i3 Research
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i3 Research Employees
Employee
Years
Job
Industry
Erin S. Orlandi Erin S. Orlandi's i3 Research Experience September 2007 - September 2009
Job Senior Clinical Research Associate, contracting through Advanced Clinical
Industry Pharmaceuticals
Experience
BioMarin Pharmaceuticals, Inc. via Advanced Clinical September 2014 - Present
Advanced Clinical September 2014 - Present
ORION Clinical Services June 2012 - August 2014
ReSearch Pharmaceutical Services, Providing Monitoring Services to Novartis Oncology May 2011 - June 2012
Lantheus Medical Imaging November 2009 - February 2011
i3 Research September 2007 - September 2009
Cardiovascular Clinical Studies, Inc. October 2006 - September 2007
Cardiovascular Clinical Studies, Inc. June 2005 - September 2007
Cardiovascular Core Laboratories, Inc. January 2006 - October 2006
Cardiovascular Clinical Studies, Inc. January 2005 - October 2006
Skills
GCP, Medical Devices, Clinical Research, Oncology, Clinical Trials, Unblinded monitoring, Clinical Site Monitoring, Cardiology, CTMS, Regulatory Affairs, Ophthalmology, Auditing, Stem Cell Research, Event Management, Project Management, Risk Management, Endocrinology, Vaccines, Psychology, Ancient History, Blinded Monitoring, FDA, Contractual Agreements, Operating Budgets, Databases, Risk Assessment, Site Operations, Astrology, Diabetes, CRO, ICH-GCP, Clinical Operations, Clinical Data Management
Education
Boston University 2003 — 2006
Bachelor in Liberal Studies, History
Massachusetts College of Art 2004 — 2006
Course Credit Only, Anatomical Design
University of North Carolina at Charlotte 2001 — 2003
Course Credit Only, Pre-Medicine: Biology
University of North Carolina at Chapel Hill / Durham Technical Community College 1999 — 2001
Course Credits Only, Pre-Medicine / Nursing
BioMarin Pharmaceuticals, Inc. via Advanced Clinical September 2014 - Present
Advanced Clinical September 2014 - Present
ORION Clinical Services June 2012 - August 2014
ReSearch Pharmaceutical Services, Providing Monitoring Services to Novartis Oncology May 2011 - June 2012
Lantheus Medical Imaging November 2009 - February 2011
i3 Research September 2007 - September 2009
Cardiovascular Clinical Studies, Inc. October 2006 - September 2007
Cardiovascular Clinical Studies, Inc. June 2005 - September 2007
Cardiovascular Core Laboratories, Inc. January 2006 - October 2006
Cardiovascular Clinical Studies, Inc. January 2005 - October 2006
Skills
GCP, Medical Devices, Clinical Research, Oncology, Clinical Trials, Unblinded monitoring, Clinical Site Monitoring, Cardiology, CTMS, Regulatory Affairs, Ophthalmology, Auditing, Stem Cell Research, Event Management, Project Management, Risk Management, Endocrinology, Vaccines, Psychology, Ancient History, Blinded Monitoring, FDA, Contractual Agreements, Operating Budgets, Databases, Risk Assessment, Site Operations, Astrology, Diabetes, CRO, ICH-GCP, Clinical Operations, Clinical Data Management
Education
Boston University 2003 — 2006
Bachelor in Liberal Studies, History
Massachusetts College of Art 2004 — 2006
Course Credit Only, Anatomical Design
University of North Carolina at Charlotte 2001 — 2003
Course Credit Only, Pre-Medicine: Biology
University of North Carolina at Chapel Hill / Durham Technical Community College 1999 — 2001
Course Credits Only, Pre-Medicine / Nursing
Eric Ramberg Eric Ramberg's i3 Research Experience December 2003 - July 2011
Job Therapeutic Lead, Oncology at Worldwide Clinical Trials
Industry Pharmaceuticals
Experience
Worldwide Clinical Trials May 2014 - Present
Viking Oncology Consulting L.L.C. December 2013 - Present
Premier Research November 2012 - September 2013
inVentiv Health Clinical July 2011 - October 2012
i3, a UnitedHealth Group Company 2009 - July 2011
i3 Research December 2003 - July 2011
INC Research January 2001 - December 2003
Quintiles 1997 - 2000
Pharmaco LSR 1992 - 1997
Kallestad Diagnostics 1982 - 1989
Skills
Oncology, CRO, Pharmaceutical Industry, Biotechnology, Clinical Development, Clinical Research, Pharmacovigilance, Drug Development, Clinical Trials, Business Development, Pharmaceutics, GCP, Therapeutic Areas, EDC, Clinical Monitoring, Protocol, Lifesciences, CTMS, Regulatory Affairs, Infectious Diseases, Neurology, ICH-GCP
Education
National Louis University
National Louis University
Iowa State University
MS, Biochemistry
Drake University
BA, Liberal Arts
Worldwide Clinical Trials May 2014 - Present
Viking Oncology Consulting L.L.C. December 2013 - Present
Premier Research November 2012 - September 2013
inVentiv Health Clinical July 2011 - October 2012
i3, a UnitedHealth Group Company 2009 - July 2011
i3 Research December 2003 - July 2011
INC Research January 2001 - December 2003
Quintiles 1997 - 2000
Pharmaco LSR 1992 - 1997
Kallestad Diagnostics 1982 - 1989
Skills
Oncology, CRO, Pharmaceutical Industry, Biotechnology, Clinical Development, Clinical Research, Pharmacovigilance, Drug Development, Clinical Trials, Business Development, Pharmaceutics, GCP, Therapeutic Areas, EDC, Clinical Monitoring, Protocol, Lifesciences, CTMS, Regulatory Affairs, Infectious Diseases, Neurology, ICH-GCP
Education
National Louis University
National Louis University
Iowa State University
MS, Biochemistry
Drake University
BA, Liberal Arts
Betsy Reid Betsy Reid's i3 Research Experience 2001 - 2003
Job Chief Operating Officer at Paidion Research, Inc.
Industry Research
Experience
Paidion Research, Inc. May 2013 - Present
Duke Clinical Research Institute April 2010 - January 2013
Duke Clinical Research Institute 2006 - April 2010
Duke Clinical Research Institute 2003 - 2006
i3 Research 2001 - 2003
Searle 1999 - 2001
Covance, Inc. 1997 - 1999
Wyeth Research 1993 - 1995
Skills
Strategy, CRO, Business Development, Clinical Trials, Clinical Research, Pharmaceutical Industry, CTMS, Strategic Planning, Change Management, Clinical Development, Management, Organizational..., Process Improvement, Team Leadership, Business Strategy, EDC, Biotechnology, GCP, Leadership, Business Planning, Leadership Development, Lifesciences, Strategic Partnerships, Cardiology, Business Analysis, Infectious Diseases, Regulatory Affairs, FDA, Marketing Communications, Medical Writing, Protocol, Healthcare, ICH-GCP, Team Building, Drug Development, Clinical Monitoring, Medical Devices, Clinical Data Management, Cross-functional Team..., Negotiation, Emerging Markets, Sales Operations, Clinical Operations, Data Management, Budgets, Recruiting, Regulatory Submissions, Operations Management, Proposal Writing, Sop
Education
Denison University 1979 — 1983
Bachelor of Arts (BA), Sociology
Paidion Research, Inc. May 2013 - Present
Duke Clinical Research Institute April 2010 - January 2013
Duke Clinical Research Institute 2006 - April 2010
Duke Clinical Research Institute 2003 - 2006
i3 Research 2001 - 2003
Searle 1999 - 2001
Covance, Inc. 1997 - 1999
Wyeth Research 1993 - 1995
Skills
Strategy, CRO, Business Development, Clinical Trials, Clinical Research, Pharmaceutical Industry, CTMS, Strategic Planning, Change Management, Clinical Development, Management, Organizational..., Process Improvement, Team Leadership, Business Strategy, EDC, Biotechnology, GCP, Leadership, Business Planning, Leadership Development, Lifesciences, Strategic Partnerships, Cardiology, Business Analysis, Infectious Diseases, Regulatory Affairs, FDA, Marketing Communications, Medical Writing, Protocol, Healthcare, ICH-GCP, Team Building, Drug Development, Clinical Monitoring, Medical Devices, Clinical Data Management, Cross-functional Team..., Negotiation, Emerging Markets, Sales Operations, Clinical Operations, Data Management, Budgets, Recruiting, Regulatory Submissions, Operations Management, Proposal Writing, Sop
Education
Denison University 1979 — 1983
Bachelor of Arts (BA), Sociology
Teri Englbrecht Teri Englbrecht's i3 Research Experience January 2010 - December 2012
Job CEO and Senior Consultant at Clinical Research Consultants
Industry Pharmaceuticals
Experience
Clinical Research Consultants May 2005 - Present
i3 Research January 2010 - December 2012
Various Pharma, Biotech and CRO companies January 1988 - May 2005
London Regional Cancer Centre 1993 - 1998
Various Hospitals and Acute Care Settings in New Jersey June 1983 - 1993
Hospital Center At Orange 1983 - 1992
American Imaging Systems 1988 - 1989
Skills
Infectious Diseases, Dermatology, Endocrinology, Rheumatology, Cardiology, Gastroenterology, Urology, Neurology, Immunology, Gene Therapy, Clinical Monitoring, ICH-GCP, Therapeutic areas, EDC, Clinical Trial..., Inform, GCP, CRO, Clinical Trials, Regulatory Submissions, Clinical Development, Clinical Research, Oncology, Hematology, CTMS, Pharmacovigilance, Diabetes, Vaccines, Asthma, Psychiatry, Regulatory Affairs, Pharmaceuticals, Protocol Development, Nephrology, COPD, Transplantation, Regulatory Requirements, Hypertension, Clinical Data Management, SOP, Patient Recruitment, Clinical, Pediatrics, Phase I, Biotechnology, Medical Devices, FDA, Osteoporosis, Transplant, Sop
Education
County College of Morris 1981 — 1983
Applied Science, Registered Nurse
Montclair State University 1979 — 1981
MA, Psychology - Family Counseling
Rider University 1975 — 1979
B.A., Sociology and Psychology
MHS 1971 — 1975
Clinical Research Consultants May 2005 - Present
i3 Research January 2010 - December 2012
Various Pharma, Biotech and CRO companies January 1988 - May 2005
London Regional Cancer Centre 1993 - 1998
Various Hospitals and Acute Care Settings in New Jersey June 1983 - 1993
Hospital Center At Orange 1983 - 1992
American Imaging Systems 1988 - 1989
Skills
Infectious Diseases, Dermatology, Endocrinology, Rheumatology, Cardiology, Gastroenterology, Urology, Neurology, Immunology, Gene Therapy, Clinical Monitoring, ICH-GCP, Therapeutic areas, EDC, Clinical Trial..., Inform, GCP, CRO, Clinical Trials, Regulatory Submissions, Clinical Development, Clinical Research, Oncology, Hematology, CTMS, Pharmacovigilance, Diabetes, Vaccines, Asthma, Psychiatry, Regulatory Affairs, Pharmaceuticals, Protocol Development, Nephrology, COPD, Transplantation, Regulatory Requirements, Hypertension, Clinical Data Management, SOP, Patient Recruitment, Clinical, Pediatrics, Phase I, Biotechnology, Medical Devices, FDA, Osteoporosis, Transplant, Sop
Education
County College of Morris 1981 — 1983
Applied Science, Registered Nurse
Montclair State University 1979 — 1981
MA, Psychology - Family Counseling
Rider University 1975 — 1979
B.A., Sociology and Psychology
MHS 1971 — 1975
Heather Leigh Wallace Heather Leigh Wallace's i3 Research Experience December 2010 - May 2012
Job Operations Management Consultant at BioMarin Pharmaceutical Inc.
Industry Pharmaceuticals
Experience
BioMarin Pharmaceutical Inc. April 2015 - Present
Onyx Pharmaceuticals an Amgen Subsidiary January 2013 - Present
Modoc Research Services April 2011 - January 2013
Saxapahaw Writers' Group, LLC December 2010 - January 2013
Veristat, Inc. May 2012 - October 2012
i3 Research December 2010 - May 2012
Medical Writers USA May 2009 - September 2010
UCB Pharma June 2007 - April 2009
Averion International (Former Hesperion) 2006 - 2007
ICON Clinical Research May 2004 - July 2006
Skills
CRO, Clinical Trials, Clinical Development, Medical Writing, GCP, CTMS, Pharmaceutical Industry, Oncology, EDC, Clinical Research, Therapeutic Areas, Regulatory Affairs, Clinical Data Management, Biotechnology, Infectious Diseases, Regulatory Submissions, Pharmacovigilance, Clinical Study Design, Drug Development, ICH-GCP, IND, Sop, Clinical Monitoring, Drug Safety, Protocol, Medical Affairs, 21 CFR Part 11, Vaccines, Biopharmaceuticals, Neurology, FDA, Dermatology, Cardiology, Immunology, Pharmacology, Lifesciences, Life Sciences
Education
Arizona State University 2014 — 2015
Master’s Degree, Clinical Research Management, 4.0
American InterContinental University
Bachelor of Business Administration (BBA), Project Management
Delaware Valley Academy of Medical and Dental Assistants 1989 — 1990
Medical Assistant (certified as a Medical Technologist)
BioMarin Pharmaceutical Inc. April 2015 - Present
Onyx Pharmaceuticals an Amgen Subsidiary January 2013 - Present
Modoc Research Services April 2011 - January 2013
Saxapahaw Writers' Group, LLC December 2010 - January 2013
Veristat, Inc. May 2012 - October 2012
i3 Research December 2010 - May 2012
Medical Writers USA May 2009 - September 2010
UCB Pharma June 2007 - April 2009
Averion International (Former Hesperion) 2006 - 2007
ICON Clinical Research May 2004 - July 2006
Skills
CRO, Clinical Trials, Clinical Development, Medical Writing, GCP, CTMS, Pharmaceutical Industry, Oncology, EDC, Clinical Research, Therapeutic Areas, Regulatory Affairs, Clinical Data Management, Biotechnology, Infectious Diseases, Regulatory Submissions, Pharmacovigilance, Clinical Study Design, Drug Development, ICH-GCP, IND, Sop, Clinical Monitoring, Drug Safety, Protocol, Medical Affairs, 21 CFR Part 11, Vaccines, Biopharmaceuticals, Neurology, FDA, Dermatology, Cardiology, Immunology, Pharmacology, Lifesciences, Life Sciences
Education
Arizona State University 2014 — 2015
Master’s Degree, Clinical Research Management, 4.0
American InterContinental University
Bachelor of Business Administration (BBA), Project Management
Delaware Valley Academy of Medical and Dental Assistants 1989 — 1990
Medical Assistant (certified as a Medical Technologist)
Susan McFarland Susan McFarland's i3 Research Experience April 2010 - June 2011
Job Clinical Team Manager III at PRA Health Sciences
Industry Pharmaceuticals
Experience
PRA Health Sciences August 2015 - Present
PAREXEL November 2014 - August 2015
PAREXEL June 2011 - November 2014
i3 Research April 2010 - June 2011
Kendle International December 2006 - February 2010
Kendle International November 2003 - December 2006
Kendle International August 2002 - November 2003
Kendle International April 2001 - August 2002
Kendle International July 1998 - April 2001
Aerotek Scientific Staffing January 1998 - July 1998
Skills
Rheumatoid Arthritis, Endocrinology, Dermatology, Hypertension, Respiration, Asthma, Central Nervous System, Type 2 Diabetes, Heart Failure, CRO, CTMS, Clinical Trials, Clinical Monitoring, GCP, EDC, Atrial Fibrillation, Clinical Development, ICH-GCP, Pharmaceutical Industry, Drug Development, Oracle Clinical, Oncology, Regulatory Affairs, Clinical Research
Education
Miami University 1996 — 1998
NA, Organic Chemistry
Georgetown College 1992 — 1996
Bachelor of Science, Chemistry
PRA Health Sciences August 2015 - Present
PAREXEL November 2014 - August 2015
PAREXEL June 2011 - November 2014
i3 Research April 2010 - June 2011
Kendle International December 2006 - February 2010
Kendle International November 2003 - December 2006
Kendle International August 2002 - November 2003
Kendle International April 2001 - August 2002
Kendle International July 1998 - April 2001
Aerotek Scientific Staffing January 1998 - July 1998
Skills
Rheumatoid Arthritis, Endocrinology, Dermatology, Hypertension, Respiration, Asthma, Central Nervous System, Type 2 Diabetes, Heart Failure, CRO, CTMS, Clinical Trials, Clinical Monitoring, GCP, EDC, Atrial Fibrillation, Clinical Development, ICH-GCP, Pharmaceutical Industry, Drug Development, Oracle Clinical, Oncology, Regulatory Affairs, Clinical Research
Education
Miami University 1996 — 1998
NA, Organic Chemistry
Georgetown College 1992 — 1996
Bachelor of Science, Chemistry
Katalin Vizkelety Katalin Vizkelety's i3 Research Experience 2011 - Present
Job CRA at i3 Research
Industry Pharmaceuticals
Experience
i3 Research 2011 - Present
Quintiles 1998 - 2010
Pharma-Regist Kft 1995 - 1997
EGIS Pharmaceuticals PLC 1983 - 1994
Education
Eötvös Loránd Tudományegyetem 1978 — 1983
Master of Science (M.Sc.), Biology
i3 Research 2011 - Present
Quintiles 1998 - 2010
Pharma-Regist Kft 1995 - 1997
EGIS Pharmaceuticals PLC 1983 - 1994
Education
Eötvös Loránd Tudományegyetem 1978 — 1983
Master of Science (M.Sc.), Biology
Konstantine Lambridis Konstantine Lambridis's i3 Research Experience August 2010 - March 2011
Job Clinical Research Associate at University of North Carolina at Chapel Hill
Industry Pharmaceuticals
Experience
University of North Carolina at Chapel Hill July 2014 - August 2015
Cato Research March 2013 - July 2014
Novella Clinical, Inc. January 2011 - March 2013
i3 Research August 2010 - March 2011
Trinity Drug Partners, LLC February 2010 - December 2010
EVOS Holdings, LLC October 1994 - January 2010
Skills
CTMS, GCP, Clinical Trials, Oncology, FDA, Clinical Research, Program Management, Project Management, Management, Leadership, Phase I, EDC, Team Leadership, CRO, Contract Negotiation, Clinical Monitoring, ICH-GCP, Strategic Planning, Clinical Data Management, Inform, INTEGRATED CORE..., Cross-functional Team..., Clinical Development
Education
Florida Institute of Technology 1986 — 1990
B.S. in Aviation Management/Flight Technology
Rollins College - Crummer Graduate School of Business
University of North Carolina at Chapel Hill July 2014 - August 2015
Cato Research March 2013 - July 2014
Novella Clinical, Inc. January 2011 - March 2013
i3 Research August 2010 - March 2011
Trinity Drug Partners, LLC February 2010 - December 2010
EVOS Holdings, LLC October 1994 - January 2010
Skills
CTMS, GCP, Clinical Trials, Oncology, FDA, Clinical Research, Program Management, Project Management, Management, Leadership, Phase I, EDC, Team Leadership, CRO, Contract Negotiation, Clinical Monitoring, ICH-GCP, Strategic Planning, Clinical Data Management, Inform, INTEGRATED CORE..., Cross-functional Team..., Clinical Development
Education
Florida Institute of Technology 1986 — 1990
B.S. in Aviation Management/Flight Technology
Rollins College - Crummer Graduate School of Business
Boyce Hudson Boyce Hudson's i3 Research Experience January 2006 - October 2007
Job Manager, Talent Delivery at MetLife
Industry Staffing and Recruiting
Experience
MetLife October 2014 - Present
Cisco December 2009 - October 2014
Fforde Management 2007 - December 2009
i3 Research January 2006 - October 2007
Randstad 1997 - 1999
Skills
Business Development, Project Management, Process Improvement, Recruiting, Human Resources, Contract Negotiation, Executive Search, Leadership, Management, Negotiation, Outsourcing, Sourcing, Strategy, Talent Acquisition, Team Management
Education
East Carolina University - College of Business 1988 — 1993
MBA
MetLife October 2014 - Present
Cisco December 2009 - October 2014
Fforde Management 2007 - December 2009
i3 Research January 2006 - October 2007
Randstad 1997 - 1999
Skills
Business Development, Project Management, Process Improvement, Recruiting, Human Resources, Contract Negotiation, Executive Search, Leadership, Management, Negotiation, Outsourcing, Sourcing, Strategy, Talent Acquisition, Team Management
Education
East Carolina University - College of Business 1988 — 1993
MBA
Jennifer Walsh Jennifer Walsh's i3 Research Experience 2004 - 2006
Job Contract Manager Site Contracts: Oncology/Hematology and Inflamation and Immunology
Industry Pharmaceuticals
Experience
Celgene November 2010 - Present
Celgene 2010 - 2012
Novartis December 2006 - November 2010
i3 Research 2004 - 2006
SN Servicing Corporation 2001 - 2003
Education
Leadership Foundation Program 2013 — 2014
Dickinson College 1996 — 2000
Gill St. Bernards 1992 — 1996
Diploma
Celgene November 2010 - Present
Celgene 2010 - 2012
Novartis December 2006 - November 2010
i3 Research 2004 - 2006
SN Servicing Corporation 2001 - 2003
Education
Leadership Foundation Program 2013 — 2014
Dickinson College 1996 — 2000
Gill St. Bernards 1992 — 1996
Diploma
Amy Carothers Amy Carothers's i3 Research Experience September 1995 - March 2012
Job LM at Parexel
Industry Pharmaceuticals
Experience
PAREXEL March 2012 - Present
i3 Research September 1995 - March 2012
Statprobe 1999 - 2001
Schering-Plough Research Institute 1990 - 1995
Parke-Davis 1987 - 1989
Skills
CRO, Data Management, Clinical Monitoring, Clinical Research, CTMS, EDC
Education
Aquinas College 1981 — 1984
BS, Biology
Michigan State University 1980 — 1981
Biology
Eastern Michigan University
Credtis toward Masters in Clinical Administration, Management
PAREXEL March 2012 - Present
i3 Research September 1995 - March 2012
Statprobe 1999 - 2001
Schering-Plough Research Institute 1990 - 1995
Parke-Davis 1987 - 1989
Skills
CRO, Data Management, Clinical Monitoring, Clinical Research, CTMS, EDC
Education
Aquinas College 1981 — 1984
BS, Biology
Michigan State University 1980 — 1981
Biology
Eastern Michigan University
Credtis toward Masters in Clinical Administration, Management
Lisa Tanser Lisa Tanser's i3 Research Experience February 2007 - June 2008
Job Country Clinical Operations Manager at Roche
Industry Pharmaceuticals
Experience
Roche October 2014 - Present
Roche October 2012 - October 2014
Roche Pharmaceuticals May 2012 - October 2014
Roche December 2011 - September 2012
i3 Statprobe February 2011 - December 2011
i3 Statprobe January 2010 - February 2011
i3 Statprobe March 2009 - January 2010
i3 Statprobe June 2008 - April 2009
i3 Research February 2007 - June 2008
AstraZeneca Canada June 2003 - February 2007
Skills
Protocol Development, Medical Writing, Clinical, Therapeutic areas, EDC, 21 CFR Part 11, Clinical Research, Scientific..., Manuscript, Protocol, GCP, Therapeutic Areas, Regulatory Documentation, Data Management, Clinical Development, Clinical Trials, NDA, Oncology, Clinical Study Design, CRO
Education
University of Toronto 1995 — 1997
MSc, Neuropsychiatry & Sleep physiology
Brock University 1990 — 1995
(Hon)BSc, Neuroscience
Roche October 2014 - Present
Roche October 2012 - October 2014
Roche Pharmaceuticals May 2012 - October 2014
Roche December 2011 - September 2012
i3 Statprobe February 2011 - December 2011
i3 Statprobe January 2010 - February 2011
i3 Statprobe March 2009 - January 2010
i3 Statprobe June 2008 - April 2009
i3 Research February 2007 - June 2008
AstraZeneca Canada June 2003 - February 2007
Skills
Protocol Development, Medical Writing, Clinical, Therapeutic areas, EDC, 21 CFR Part 11, Clinical Research, Scientific..., Manuscript, Protocol, GCP, Therapeutic Areas, Regulatory Documentation, Data Management, Clinical Development, Clinical Trials, NDA, Oncology, Clinical Study Design, CRO
Education
University of Toronto 1995 — 1997
MSc, Neuropsychiatry & Sleep physiology
Brock University 1990 — 1995
(Hon)BSc, Neuroscience
Frederick Murray Frederick Murray's i3 Research Experience 2006 - 2008
Job Director of Endocrinology, Diabtes and Metabolic Diseases at Upstate Physicians Services PC
Industry Biotechnology
Experience
Upstate Physicians Services PC August 2015 - Present
TOPMED INC. August 2013 - Present
Edotherapeutics July 2008 - August 2010
i3 Research 2006 - 2008
Altus Pharmaceuticals August 2004 - December 2006
Aventis Pharmaceuticals April 2003 - August 2004
Takeda Pharmaceuticals January 2002 - September 2003
EMD Serono, Inc. January 1997 - January 2002
The Upjohn Company January 1992 - January 1997
Skills
Medical Writing, Clinical Pharmacology, Hypertension, Cardiology, Dermatology, GCP, Vaccines, Pharmacology, Inflammation, Neuroscience, Regulatory Submissions, Lifesciences, Regulatory Affairs, Medical Affairs, Medical Research, Protocol, Biostatistics, FDA, Medical Devices, Diabetes, Clinical Development, Life Sciences, Drug Development, Endocrinology, Healthcare
Education
Penn State Hershey Medical Center 1976 — 1978
Adult, Pediatric and Neonatology Fellowship in Endocrinology and Metabolic diseases, Reproctive Endocrinology, Steroid Metabolism and Reproductive Complications of Diabetes
University of Totronto, Toronto, Ontario, Canada 1974 — 1976
Diabetes and Endocrinology Fellowship; Fellowship with The Artificial Pancreas Group, sick Children, Basel In sulin Delivery; Animal Models of Diabetes
State University of New York Upstate Medical University 1972 — 1974
Residency in Internal medicine, Internal medicine
Maine Medical Center 1971 — 1972
Internship in Surgery & Internal Medicine, Internal Medicine & Surgery
Drexel University College of Medicine 1967 — 1971
MD, medicine
Franklin & Marshall College 1962 — 1967
Bachelor's degree, Biology, General
Upstate Physicians Services PC August 2015 - Present
TOPMED INC. August 2013 - Present
Edotherapeutics July 2008 - August 2010
i3 Research 2006 - 2008
Altus Pharmaceuticals August 2004 - December 2006
Aventis Pharmaceuticals April 2003 - August 2004
Takeda Pharmaceuticals January 2002 - September 2003
EMD Serono, Inc. January 1997 - January 2002
The Upjohn Company January 1992 - January 1997
Skills
Medical Writing, Clinical Pharmacology, Hypertension, Cardiology, Dermatology, GCP, Vaccines, Pharmacology, Inflammation, Neuroscience, Regulatory Submissions, Lifesciences, Regulatory Affairs, Medical Affairs, Medical Research, Protocol, Biostatistics, FDA, Medical Devices, Diabetes, Clinical Development, Life Sciences, Drug Development, Endocrinology, Healthcare
Education
Penn State Hershey Medical Center 1976 — 1978
Adult, Pediatric and Neonatology Fellowship in Endocrinology and Metabolic diseases, Reproctive Endocrinology, Steroid Metabolism and Reproductive Complications of Diabetes
University of Totronto, Toronto, Ontario, Canada 1974 — 1976
Diabetes and Endocrinology Fellowship; Fellowship with The Artificial Pancreas Group, sick Children, Basel In sulin Delivery; Animal Models of Diabetes
State University of New York Upstate Medical University 1972 — 1974
Residency in Internal medicine, Internal medicine
Maine Medical Center 1971 — 1972
Internship in Surgery & Internal Medicine, Internal Medicine & Surgery
Drexel University College of Medicine 1967 — 1971
MD, medicine
Franklin & Marshall College 1962 — 1967
Bachelor's degree, Biology, General
Tamara Gould Tamara Gould's i3 Research Experience 1997 - 2000
Job Experienced Pharmaceutical Professional with over 10 years of monitoring, regulatory and site management experience
Industry Pharmaceuticals
Experience
Gould Clinical Resourcing July 2010 - Present
sanofi-aventis July 2001 - Present
Novartis Pharmaceuticals 2001 - 2002
i3 Research 1997 - 2000
Skills
Sleep Medicine, CRO, Clinical Trials, Clinical Monitoring
Education
D'Youville College 1984 — 1987
BSN, Nursing
D'Youville College, University of Buffalo 1984 — 1987
Kenmore West
Gould Clinical Resourcing July 2010 - Present
sanofi-aventis July 2001 - Present
Novartis Pharmaceuticals 2001 - 2002
i3 Research 1997 - 2000
Skills
Sleep Medicine, CRO, Clinical Trials, Clinical Monitoring
Education
D'Youville College 1984 — 1987
BSN, Nursing
D'Youville College, University of Buffalo 1984 — 1987
Kenmore West
Jess Vicari Jess Vicari's i3 Research Experience February 2010 - August 2011
Job Director, Regulatory Startup & Document Management at Advanced Clinical
Industry Pharmaceuticals
Experience
Advanced Clinical September 2013 - Present
inVentiv Health Clinical January 2012 - September 2013
PharmaNet/i3, an inVentiv Health company June 2011 - March 2012
i3 Research February 2010 - August 2011
i3 Research October 2007 - February 2010
Canfield Scientific November 2004 - October 2007
Canfield Scientific November 2003 - November 2004
Snelling Staffing Services August 2002 - October 2003
Drew University November 1998 - August 2000
Skills
Clinical Trials, CTMS, GCP, CRO, Clinical Development, EDC, Clinical Research, ICH-GCP, Pharmaceutical Industry, Clinical Monitoring, Medical Writing, Clinical Data Management, Regulatory Submissions, TMF, Oncology, Therapeutic Areas, Cloud-based, Regulatory Requirements, Compliance, Quality Assurance, Computer System..., IRB, Vendor Management
Education
Drew University 2000 — 2002
BA, Behavioral Science, Madison, NJ
Villanova University 1996 — 1998
n/a, Psychology
Oak Knoll School
Advanced Clinical September 2013 - Present
inVentiv Health Clinical January 2012 - September 2013
PharmaNet/i3, an inVentiv Health company June 2011 - March 2012
i3 Research February 2010 - August 2011
i3 Research October 2007 - February 2010
Canfield Scientific November 2004 - October 2007
Canfield Scientific November 2003 - November 2004
Snelling Staffing Services August 2002 - October 2003
Drew University November 1998 - August 2000
Skills
Clinical Trials, CTMS, GCP, CRO, Clinical Development, EDC, Clinical Research, ICH-GCP, Pharmaceutical Industry, Clinical Monitoring, Medical Writing, Clinical Data Management, Regulatory Submissions, TMF, Oncology, Therapeutic Areas, Cloud-based, Regulatory Requirements, Compliance, Quality Assurance, Computer System..., IRB, Vendor Management
Education
Drew University 2000 — 2002
BA, Behavioral Science, Madison, NJ
Villanova University 1996 — 1998
n/a, Psychology
Oak Knoll School
Richard Stroder's i3 Research Experience March 2004 - September 2004
Job Global Operations Leader at ViiV Healthcare
Industry Pharmaceuticals
Experience
ViiV Healthcare August 2014 - Present
GlaxoSmithKline May 2005 - Present
Trio Clinical Resourcing September 2004 - May 2005
i3 Research March 2004 - September 2004
Inveresk Research October 2003 - February 2004
PharmaResearch, Inc November 2002 - September 2003
PharmaResearch, Inc. September 1999 - October 2002
PharmaResearch, Inc. February 1999 - August 1999
Healthfield Hospice, Inc. November 1996 - February 1999
Grady Health System August 1996 - November 1996
Skills
Clinical Trials, Clinical Monitoring, Clinical Development, GCP, Clinical Trial..., CRO, Clinical Research, Protocol Development, Infectious Diseases, ICH-GCP, Nursing, Inform
Education
Emory University 1993 — 1995
Bachelors of Science, Nursing
ViiV Healthcare August 2014 - Present
GlaxoSmithKline May 2005 - Present
Trio Clinical Resourcing September 2004 - May 2005
i3 Research March 2004 - September 2004
Inveresk Research October 2003 - February 2004
PharmaResearch, Inc November 2002 - September 2003
PharmaResearch, Inc. September 1999 - October 2002
PharmaResearch, Inc. February 1999 - August 1999
Healthfield Hospice, Inc. November 1996 - February 1999
Grady Health System August 1996 - November 1996
Skills
Clinical Trials, Clinical Monitoring, Clinical Development, GCP, Clinical Trial..., CRO, Clinical Research, Protocol Development, Infectious Diseases, ICH-GCP, Nursing, Inform
Education
Emory University 1993 — 1995
Bachelors of Science, Nursing
Christopher Crucitti Christopher Crucitti's i3 Research Experience October 2005 - February 2009
Job Executive Vice President,Global Business Development Worldwide Clinical Trials Scientifically Minded, Medically Driven
Industry Pharmaceuticals
Experience
Worldwide Clinical Trials, Inc. February 2012 - Present
inVentiv Health Clinical June 2011 - February 2012
inVentiv Clinical Solutions February 2009 - June 2011
i3 Research October 2005 - February 2009
Ingenix October 2005 - February 2009
Skills
Business Development, Sales Management, Financial Reporting, Pharmaceutical Industry, Oncology, CRO, Clinical Trials, Biotechnology, Clinical Research, Clinical Development, Medical Devices, Lifesciences, CTMS, Therapeutic Areas, Commercialization, Drug Development, Cross-functional Team..., Regulatory Affairs, Clinical Data Management, Leadership, Management, EDC, GCP, Strategic Planning, Healthcare, Regulatory Submissions, Clinical Operations, Pharmacovigilance, Neurology, Life Sciences
Education
American University 2001 — 2003
MS, Health Management
Ithaca College 1997 — 2001
BS, Cardiac Rehabilitation and Exercise Science
Worldwide Clinical Trials, Inc. February 2012 - Present
inVentiv Health Clinical June 2011 - February 2012
inVentiv Clinical Solutions February 2009 - June 2011
i3 Research October 2005 - February 2009
Ingenix October 2005 - February 2009
Skills
Business Development, Sales Management, Financial Reporting, Pharmaceutical Industry, Oncology, CRO, Clinical Trials, Biotechnology, Clinical Research, Clinical Development, Medical Devices, Lifesciences, CTMS, Therapeutic Areas, Commercialization, Drug Development, Cross-functional Team..., Regulatory Affairs, Clinical Data Management, Leadership, Management, EDC, GCP, Strategic Planning, Healthcare, Regulatory Submissions, Clinical Operations, Pharmacovigilance, Neurology, Life Sciences
Education
American University 2001 — 2003
MS, Health Management
Ithaca College 1997 — 2001
BS, Cardiac Rehabilitation and Exercise Science
Amy O'Donnell Amy O'Donnell's i3 Research Experience 2007 - Present
Job Executive Medical Director, Pain and Neuroscience, inVentiv Health Clinical
Industry Pharmaceuticals
Experience
i3 Research 2007 - Present
Education
Brown University Medical School 1990 — 1994
Doctor of Medicine (MD)
New York University School of Law 1984 — 1987
Doctor of Law (JD)
Bryn Mawr College 1981 — 1984
Bachelor of Arts (B.A.), English Language and Literature/Letters
i3 Research 2007 - Present
Education
Brown University Medical School 1990 — 1994
Doctor of Medicine (MD)
New York University School of Law 1984 — 1987
Doctor of Law (JD)
Bryn Mawr College 1981 — 1984
Bachelor of Arts (B.A.), English Language and Literature/Letters
Stacey McKinney Stacey McKinney's i3 Research Experience September 2006 - July 2012
Job Project Manager
Industry Pharmaceuticals
Experience
PRA Health Sciences July 2015 - Present
Quintiles August 2012 - July 2015
i3 Research September 2006 - July 2012
Rho August 2005 - August 2006
INC Research February 2004 - August 2005
Rho December 2003 - January 2004
Household Finance January 2003 - September 2003
Education
East Carolina University - College of Business 1999 — 2002
Marketing
PRA Health Sciences July 2015 - Present
Quintiles August 2012 - July 2015
i3 Research September 2006 - July 2012
Rho August 2005 - August 2006
INC Research February 2004 - August 2005
Rho December 2003 - January 2004
Household Finance January 2003 - September 2003
Education
East Carolina University - College of Business 1999 — 2002
Marketing
Edward Bartolic Edward Bartolic's i3 Research Experience September 2007 - May 2011
Job Neuropsychologist | Pharmaceutical Researcher
Industry Pharmaceuticals
Experience
Cogstate February 2014 - Present
Worldwide Clinical Trials, Inc January 2012 - December 2013
i3 Research September 2007 - May 2011
i3 Research October 2004 - September 2007
i3 Research July 2003 - October 2004
i3 Research November 2002 - July 2003
i3 Research July 2001 - November 2002
Medical College of Pennsylvania and Hahnemann University January 1996 - January 2001
Medical College of Pennsylvania and Hahnemann University January 1994 - January 1996
Skills
Integrating CNS..., Effective presentation..., Developing, editing and..., Therapeutic expertise..., Ability to acquire,..., Diverse knowledge of..., Developing..., Therapeutic Areas, Clinical Research, Psychiatry, CRO, Neurology, Pharmaceutical Industry, Science, Biotechnology, Protocol, Pharmaceutics, CTMS, Medicine, Therapists, Clinical Trials, Clinical Development, Medical Writing, Management, Proposal Writing, Clinical Study Design, Research, Central Nervous System, Leadership, Hospitals, Training
Education
University of Cincinnati 1989 — 1994
PhD, Clinical Psychology
University of Cincinnati 1986 — 1989
MA, Clinical Psychology
Bowling Green State University 1980 — 1984
BS, Psychology
Cogstate February 2014 - Present
Worldwide Clinical Trials, Inc January 2012 - December 2013
i3 Research September 2007 - May 2011
i3 Research October 2004 - September 2007
i3 Research July 2003 - October 2004
i3 Research November 2002 - July 2003
i3 Research July 2001 - November 2002
Medical College of Pennsylvania and Hahnemann University January 1996 - January 2001
Medical College of Pennsylvania and Hahnemann University January 1994 - January 1996
Skills
Integrating CNS..., Effective presentation..., Developing, editing and..., Therapeutic expertise..., Ability to acquire,..., Diverse knowledge of..., Developing..., Therapeutic Areas, Clinical Research, Psychiatry, CRO, Neurology, Pharmaceutical Industry, Science, Biotechnology, Protocol, Pharmaceutics, CTMS, Medicine, Therapists, Clinical Trials, Clinical Development, Medical Writing, Management, Proposal Writing, Clinical Study Design, Research, Central Nervous System, Leadership, Hospitals, Training
Education
University of Cincinnati 1989 — 1994
PhD, Clinical Psychology
University of Cincinnati 1986 — 1989
MA, Clinical Psychology
Bowling Green State University 1980 — 1984
BS, Psychology
Randy Dunson, MS, MBA, PMP Randy Dunson, MS, MBA, PMP's i3 Research Experience 2008 - 2008
Job Biopharmaceutical Project Management and Training & Development Consultant
Industry Pharmaceuticals
Experience
Independent Project Management Consultancy June 2008 - Present
Cempra Pharmaceuticals January 2012 - February 2012
Project Management Institute January 2004 - May 2011
i3 Research 2008 - 2008
Harpum Consulting Ltd 2006 - 2008
Chiltern International 2006 - 2007
Equinox Consulting LLC 2005 - 2007
Duke Clinical Research Institute 2003 - 2005
GlaxoSmithKline 2001 - 2003
PAREXEL 1998 - 2001
Skills
Project Management Best..., Six Sigma, Budget Management, Communication Skills, Clinical..., Schedule Planning &..., Vendor Management, Cost/Scope Management, Training and Development, Organizational..., Strategic Consulting, Process Consulting, Relationship Management, Expertise in strategic..., Creative Problem Solving, Collaborative Problem..., Clinical and R&D..., Strategic Planning, Clinical Research, R&D, CRO, Planning, Project Management, Project Planning, Control Theory, Management, Research, Clinical Development, Consulting, Program Management, Budgets, Drug Development, PMP, MS Project, Cross-functional Team..., Project Portfolio..., Clinical Trials, Leadership, Analysis, Biotechnology, Training, Lifesciences, Change Management, Data Management, PMO, Product Development, Medical Writing, Process Improvement, Sop, Proposal Writing
Education
Coursea 2012 — 2013
NA, Various
Elon University - Martha and Spencer Love School of Business 2003 — 2004
MBA, Finance, Strategic Planning
East Carolina University 1977 — 1979
MS, Biology
East Carolina University 1972 — 1976
BA, Biology
Independent Project Management Consultancy June 2008 - Present
Cempra Pharmaceuticals January 2012 - February 2012
Project Management Institute January 2004 - May 2011
i3 Research 2008 - 2008
Harpum Consulting Ltd 2006 - 2008
Chiltern International 2006 - 2007
Equinox Consulting LLC 2005 - 2007
Duke Clinical Research Institute 2003 - 2005
GlaxoSmithKline 2001 - 2003
PAREXEL 1998 - 2001
Skills
Project Management Best..., Six Sigma, Budget Management, Communication Skills, Clinical..., Schedule Planning &..., Vendor Management, Cost/Scope Management, Training and Development, Organizational..., Strategic Consulting, Process Consulting, Relationship Management, Expertise in strategic..., Creative Problem Solving, Collaborative Problem..., Clinical and R&D..., Strategic Planning, Clinical Research, R&D, CRO, Planning, Project Management, Project Planning, Control Theory, Management, Research, Clinical Development, Consulting, Program Management, Budgets, Drug Development, PMP, MS Project, Cross-functional Team..., Project Portfolio..., Clinical Trials, Leadership, Analysis, Biotechnology, Training, Lifesciences, Change Management, Data Management, PMO, Product Development, Medical Writing, Process Improvement, Sop, Proposal Writing
Education
Coursea 2012 — 2013
NA, Various
Elon University - Martha and Spencer Love School of Business 2003 — 2004
MBA, Finance, Strategic Planning
East Carolina University 1977 — 1979
MS, Biology
East Carolina University 1972 — 1976
BA, Biology
Tara Hun-Dorris's i3 Research Experience 2001 - 2004
Job Owner, Freelance Medical Writer, THD Editorial, Inc.
Industry Pharmaceuticals
Experience
THD Editorial, Inc. 2004 - Present
Ingenix/i3 Research 2001 - 2004
Ingenix 2001 - 2004
i3 Research 2001 - 2004
i3 Pharma Resourcing, a UnitedHealth Group Company 2001 - 2004
North Carolina School Boards Association 1999 - 2000
Water Environment Federation 1997 - 1999
South Carolina DAODAS August 1995 - April 1997
Jobson Publishing 1996 - 1996
National Environmental Training Center for Small Communities 1993 - 1995
Skills
Medical Writing, Oncology, Regulatory Submissions, Publications, Protocol, GCP, Vaccines, Asthma, Neurology, Infectious Diseases, Study Reports, Therapeutic Areas, Rheumatoid Arthritis, Clinical Study Design, Diabetes, Publication Planning, Medical Communications, Manuscript, Analgesia, Medicine, Medical Education, IND, Dermatology, Project Management, Contractor Management, Informed Consent, Regulatory document QC, Medical editing, Medical, Editing
Education
University of South Carolina-Columbia 1995 — 1997
Masters, Mass Communications
West Virginia University 1992 — 1995
B.S., Journalism
Kansas State University 1991 — 1992
Journalism
THD Editorial, Inc. 2004 - Present
Ingenix/i3 Research 2001 - 2004
Ingenix 2001 - 2004
i3 Research 2001 - 2004
i3 Pharma Resourcing, a UnitedHealth Group Company 2001 - 2004
North Carolina School Boards Association 1999 - 2000
Water Environment Federation 1997 - 1999
South Carolina DAODAS August 1995 - April 1997
Jobson Publishing 1996 - 1996
National Environmental Training Center for Small Communities 1993 - 1995
Skills
Medical Writing, Oncology, Regulatory Submissions, Publications, Protocol, GCP, Vaccines, Asthma, Neurology, Infectious Diseases, Study Reports, Therapeutic Areas, Rheumatoid Arthritis, Clinical Study Design, Diabetes, Publication Planning, Medical Communications, Manuscript, Analgesia, Medicine, Medical Education, IND, Dermatology, Project Management, Contractor Management, Informed Consent, Regulatory document QC, Medical editing, Medical, Editing
Education
University of South Carolina-Columbia 1995 — 1997
Masters, Mass Communications
West Virginia University 1992 — 1995
B.S., Journalism
Kansas State University 1991 — 1992
Journalism
Richard Malloy, MS, RRT, MRQA Richard Malloy, MS, RRT, MRQA's i3 Research Experience January 2008 - Present
Job Assistant Director Quality Assurance Good Clinical Practice
Industry Biotechnology
Experience
ViroPharma Incorporated July 2009 - Present
ViroPharma Incorporated July 2009 - Present
Viro Pharmaceutical July 2009 - Present
Duke University Medical Center July 2009 - Present
i3 Research January 2008 - Present
cell Therapeutics September 2007 - Present
HUP 2011 - 2011
GCPCetero Research February 2008 - February 2009
Cetero Research January 2008 - January 2009
international corporation January 2008 - January 2009
Skills
Clinical Trials, Clinical Development, GCP, CRO, CTMS
Education
California State University-Bakersfield 1981 — 1983
BSHCM, Health Care Management
Almeda University
2003BS; AAS, MS; Health Care Management; Respiratory Therapy
Community College of Philadelphia
Nursing
Medical College of Pennsylvania
ViroPharma Incorporated July 2009 - Present
ViroPharma Incorporated July 2009 - Present
Viro Pharmaceutical July 2009 - Present
Duke University Medical Center July 2009 - Present
i3 Research January 2008 - Present
cell Therapeutics September 2007 - Present
HUP 2011 - 2011
GCPCetero Research February 2008 - February 2009
Cetero Research January 2008 - January 2009
international corporation January 2008 - January 2009
Skills
Clinical Trials, Clinical Development, GCP, CRO, CTMS
Education
California State University-Bakersfield 1981 — 1983
BSHCM, Health Care Management
Almeda University
2003BS; AAS, MS; Health Care Management; Respiratory Therapy
Community College of Philadelphia
Nursing
Medical College of Pennsylvania
Jann Nielsen Jann Nielsen's i3 Research Experience November 2009 - October 2010
Job Drug Development … Project Management … Neurosciences... at Team Leadership
Industry Pharmaceuticals
Experience
Team Leadership May 2012 - Present
Shire Pharmaceuticals December 2010 - May 2012
i3 Research November 2009 - October 2010
Pfizer October 2009 - November 2009
Wyeth January 2001 - November 2009
Wyeth Pharmaceuticals 2001 - October 2009
Wyeth Research 2001 - October 2009
Solvay Pharmaceuticals April 2004 - February 2008
Wyeth 2001 - 2007
Wyeth 2001 - 2007
Skills
Drug Development, Neuroscience, Business Alliances, Pharmaceutical Industry, Clinical Development, Clinical Trials, Biotechnology, Regulatory Affairs, Lifesciences, Oncology, Drug Discovery, FDA, Therapeutic Areas, Cross-functional Team..., Regulatory Submissions, CRO, Strategy
Education
University of Minnesota-Twin Cities 1975 — 1979
PhD
Kalamazoo College 1969 — 1973
BA
Portage Northern High School 1965 — 1969
HS, Premed
Team Leadership May 2012 - Present
Shire Pharmaceuticals December 2010 - May 2012
i3 Research November 2009 - October 2010
Pfizer October 2009 - November 2009
Wyeth January 2001 - November 2009
Wyeth Pharmaceuticals 2001 - October 2009
Wyeth Research 2001 - October 2009
Solvay Pharmaceuticals April 2004 - February 2008
Wyeth 2001 - 2007
Wyeth 2001 - 2007
Skills
Drug Development, Neuroscience, Business Alliances, Pharmaceutical Industry, Clinical Development, Clinical Trials, Biotechnology, Regulatory Affairs, Lifesciences, Oncology, Drug Discovery, FDA, Therapeutic Areas, Cross-functional Team..., Regulatory Submissions, CRO, Strategy
Education
University of Minnesota-Twin Cities 1975 — 1979
PhD
Kalamazoo College 1969 — 1973
BA
Portage Northern High School 1965 — 1969
HS, Premed
William Jacobson William Jacobson's i3 Research Experience August 2009 - October 2010
Job Senior Scientific Director, Global Clinical Science at Takeda Development Center Americas
Industry Pharmaceuticals
Experience
Takeda Development Center Americas April 2014 - Present
Takeda Development Center Americas April 2014 - Present
Independant Strategic Drug Development Consultant December 2011 - April 2014
OptumInsight October 2010 - December 2011
I3 Research August 2009 - October 2010
Wyeth Pharmaceuticals April 2002 - August 2009
Insmed Incorporated February 2000 - March 2002
Pfizer May 1996 - January 2000
Apotex inc January 1993 - April 1996
University of Toronto September 1988 - January 1993
Skills
Regulatory Policy, Drug Development, Regulatory Guidelines, Regulatory Affairs, Program Management, Clinical Development, Pharmaceutical Industry, Medical Affairs, Medical Devices, Drug Discovery, Translational Medicine, Neuroscience, Therapeutic Areas, Clinical Research, Biopharmaceuticals, Clinical Trials, Cross-functional Team..., Pharmaceutics, CRO, Oncology, CTMS, Biotechnology, GCP, Infectious Diseases, Cardiology, Clinical Data Management, Diabetes, ICH-GCP, Clinical Operations, Pharmacology, Regulatory Requirements, Clinical Monitoring, IND, Vaccines, Endocrinology, Clinical Study Design, Neurology, Dermatology, FDA, Lifesciences, Medicine, Regulatory Submissions, Protocol, 21 CFR Part 11, EDC, Medical Writing, GMP, Pharmacovigilance, Immunology, Sop
Education
University of Florida 1986 — 1988
Fellowship, Obstetrics and Gynecology
Dalhousie University 1982 — 1986
Ph.D., Reproductive Endocrinology
Dalhousie University 1980 — 1982
M.Sc., Physiology of exercise
Concordia University 1975 — 1980
B.Sc., Biological Sciences
Concordia University 1969 — 1972
Diplome des Etudes Collegiales, Science
Malcolm Campbell High School 1965 — 1969
Takeda Development Center Americas April 2014 - Present
Takeda Development Center Americas April 2014 - Present
Independant Strategic Drug Development Consultant December 2011 - April 2014
OptumInsight October 2010 - December 2011
I3 Research August 2009 - October 2010
Wyeth Pharmaceuticals April 2002 - August 2009
Insmed Incorporated February 2000 - March 2002
Pfizer May 1996 - January 2000
Apotex inc January 1993 - April 1996
University of Toronto September 1988 - January 1993
Skills
Regulatory Policy, Drug Development, Regulatory Guidelines, Regulatory Affairs, Program Management, Clinical Development, Pharmaceutical Industry, Medical Affairs, Medical Devices, Drug Discovery, Translational Medicine, Neuroscience, Therapeutic Areas, Clinical Research, Biopharmaceuticals, Clinical Trials, Cross-functional Team..., Pharmaceutics, CRO, Oncology, CTMS, Biotechnology, GCP, Infectious Diseases, Cardiology, Clinical Data Management, Diabetes, ICH-GCP, Clinical Operations, Pharmacology, Regulatory Requirements, Clinical Monitoring, IND, Vaccines, Endocrinology, Clinical Study Design, Neurology, Dermatology, FDA, Lifesciences, Medicine, Regulatory Submissions, Protocol, 21 CFR Part 11, EDC, Medical Writing, GMP, Pharmacovigilance, Immunology, Sop
Education
University of Florida 1986 — 1988
Fellowship, Obstetrics and Gynecology
Dalhousie University 1982 — 1986
Ph.D., Reproductive Endocrinology
Dalhousie University 1980 — 1982
M.Sc., Physiology of exercise
Concordia University 1975 — 1980
B.Sc., Biological Sciences
Concordia University 1969 — 1972
Diplome des Etudes Collegiales, Science
Malcolm Campbell High School 1965 — 1969
Matt Spivey Matt Spivey's i3 Research Experience 1999 - 2004
Job Director, IT Operations at Great Expressions Dental Centers
Industry Information Technology and Services
Experience
Great Expressions Dental Centers March 2015 - Present
Great Expressions Dental Centers April 2014 - Present
Eastern Michigan University November 2008 - Present
Team Red, White & Blue June 2012 - Present
Lifestyle Lift February 2010 - April 2014
Huron Hills Church June 2009 - January 2014
NetEnrich November 2008 - February 2010
Conexio Technology Solutions, LLC. October 2005 - November 2008
UnitedHealth Group 1999 - 2005
i3 Research 1999 - 2004
Skills
IT Management, Disaster Recovery, Vendor Management, Management, Leadership, CRM, Networking, ITIL, Team Leadership, Network Administration, IT Operations, Process Improvement, Project Management, Strategic Planning, Strategy, Managed Services, Training, Cisco Technologies
Education
Eastern Michigan University 2005 — 2007
M.S, Technology Management
Eastern Michigan University 2000 — 2006
B.S, Technolgy Management
Washtenaw Community College 2000 — 2002
A.S, Computer Science
Great Expressions Dental Centers March 2015 - Present
Great Expressions Dental Centers April 2014 - Present
Eastern Michigan University November 2008 - Present
Team Red, White & Blue June 2012 - Present
Lifestyle Lift February 2010 - April 2014
Huron Hills Church June 2009 - January 2014
NetEnrich November 2008 - February 2010
Conexio Technology Solutions, LLC. October 2005 - November 2008
UnitedHealth Group 1999 - 2005
i3 Research 1999 - 2004
Skills
IT Management, Disaster Recovery, Vendor Management, Management, Leadership, CRM, Networking, ITIL, Team Leadership, Network Administration, IT Operations, Process Improvement, Project Management, Strategic Planning, Strategy, Managed Services, Training, Cisco Technologies
Education
Eastern Michigan University 2005 — 2007
M.S, Technology Management
Eastern Michigan University 2000 — 2006
B.S, Technolgy Management
Washtenaw Community College 2000 — 2002
A.S, Computer Science
Tita (Jeter) Simmons, MSQR, RAC, CSSBB, CQM Tita (Jeter) Simmons, MSQR, RAC, CSSBB, CQM's i3 Research Experience 2003 - 2004
Job Senior Director, Global Quality, Regulatory Affairs & Operational Excellence
Industry Pharmaceuticals
Experience
Health Decisions January 2014 - Present
Health Decisions August 2012 - January 2014
Health Decisions March 2012 - August 2012
Copernicus Group IRB June 2011 - March 2012
Copernicus Group IRB June 2010 - June 2011
Duke University Medical Center July 2008 - June 2010
PPD July 2007 - July 2008
Encysive Pharmaceuticals July 2004 - June 2007
i3 Research 2003 - 2004
Eisai Medical Research May 2002 - December 2003
Skills
Continuous Improvement, Quality Management, Auditing, ISO, Quality Systems, Six Sigma, Kaizen, Process Improvement, Risk Management, Lean Sigma, Compliance Management, Regulatory Affairs, Regulatory Submissions, Quality System, FDA, GCP, Sop, ISO 13485, Clinical Research, Validation, Quality Assurance, Pharmaceutical Industry, GLP, Clinical Trials, EDC, 21 CFR Part 11, CRO, Software Documentation, CAPA, Cross-functional Team..., GMP, GxP, Quality Control, Clinical Development, CTMS, Biotechnology, Change Control, Quality Auditing, Medical Devices, Regulatory Requirements
Education
Temple Graduate School of Pharmacy 2003 — 2006
MS
Kean University 1992 — 2002
BS
Health Decisions January 2014 - Present
Health Decisions August 2012 - January 2014
Health Decisions March 2012 - August 2012
Copernicus Group IRB June 2011 - March 2012
Copernicus Group IRB June 2010 - June 2011
Duke University Medical Center July 2008 - June 2010
PPD July 2007 - July 2008
Encysive Pharmaceuticals July 2004 - June 2007
i3 Research 2003 - 2004
Eisai Medical Research May 2002 - December 2003
Skills
Continuous Improvement, Quality Management, Auditing, ISO, Quality Systems, Six Sigma, Kaizen, Process Improvement, Risk Management, Lean Sigma, Compliance Management, Regulatory Affairs, Regulatory Submissions, Quality System, FDA, GCP, Sop, ISO 13485, Clinical Research, Validation, Quality Assurance, Pharmaceutical Industry, GLP, Clinical Trials, EDC, 21 CFR Part 11, CRO, Software Documentation, CAPA, Cross-functional Team..., GMP, GxP, Quality Control, Clinical Development, CTMS, Biotechnology, Change Control, Quality Auditing, Medical Devices, Regulatory Requirements
Education
Temple Graduate School of Pharmacy 2003 — 2006
MS
Kean University 1992 — 2002
BS
Venessa Galate Venessa Galate's i3 Research Experience April 2011 - March 2012
Job Senior Director, Johnson & Johnson Quality Systems Shared Services at Johnson & Johnson
Industry Pharmaceuticals
Experience
Johnson & Johnson September 2015 - Present
Johnson & Johnson April 2013 - Present
Johnson & Johnson January 2012 - Present
i3 Research April 2011 - March 2012
Roche-Genentech July 2009 - April 2011
Roche Pharmaceuticals July 2004 - July 2009
Skills
Pharmaceutical Industry, Clinical Trials, GCP, CTMS, Quality Assurance, Oncology, Change Management, CRO, FDA, EDC, Clinical Development, Clinical Research, Biotechnology, GxP, Pharmacovigilance, ICH-GCP, 21 CFR Part 11
Education
Fairleigh Dickinson University 1999 — 2003
Bachelor of Science (B.S.), International Business
Berkeley College-New York 1996 — 1998
International Business
Johnson & Johnson September 2015 - Present
Johnson & Johnson April 2013 - Present
Johnson & Johnson January 2012 - Present
i3 Research April 2011 - March 2012
Roche-Genentech July 2009 - April 2011
Roche Pharmaceuticals July 2004 - July 2009
Skills
Pharmaceutical Industry, Clinical Trials, GCP, CTMS, Quality Assurance, Oncology, Change Management, CRO, FDA, EDC, Clinical Development, Clinical Research, Biotechnology, GxP, Pharmacovigilance, ICH-GCP, 21 CFR Part 11
Education
Fairleigh Dickinson University 1999 — 2003
Bachelor of Science (B.S.), International Business
Berkeley College-New York 1996 — 1998
International Business
Nicole Olivieri - Schupp's i3 Research Experience January 2009 - September 2011
Job Talent Development
Industry Accounting
Experience
AICPA February 2015 - Present
Quintiles September 2011 - February 2015
i3 Research January 2009 - September 2011
Biogen Idec 2007 - 2009
Biogen Idec 2004 - 2007
PharmaTrainers Institute 2001 - 2004
Fujifilm Diosynth Biotechnologies 1997 - 2000
AAIPharma Services Corp. 1990 - 1997
Skills
Pharmaceutical Industry, Captivate, Learning Management..., GMP, Instructor-led Training, Instructional Design, Learning Management, E-Learning, Training Delivery, Needs Analysis, Blended Learning, 21 CFR Part 11, Performance Management, Technical Writing, Training, Employee Training, Quality Assurance, Sop, Hands-on Training, Organizational..., Succession Planning, ADDIE, Career Development, Management Development, Software Documentation, SOP
Education
North Carolina State University 2006 — 2011
M.Ed Candidate, Training and Development, Completed all coursework: 4.0 GPA
California University of Pennsylvania 1986 — 1990
B.S., Chemistry
AICPA February 2015 - Present
Quintiles September 2011 - February 2015
i3 Research January 2009 - September 2011
Biogen Idec 2007 - 2009
Biogen Idec 2004 - 2007
PharmaTrainers Institute 2001 - 2004
Fujifilm Diosynth Biotechnologies 1997 - 2000
AAIPharma Services Corp. 1990 - 1997
Skills
Pharmaceutical Industry, Captivate, Learning Management..., GMP, Instructor-led Training, Instructional Design, Learning Management, E-Learning, Training Delivery, Needs Analysis, Blended Learning, 21 CFR Part 11, Performance Management, Technical Writing, Training, Employee Training, Quality Assurance, Sop, Hands-on Training, Organizational..., Succession Planning, ADDIE, Career Development, Management Development, Software Documentation, SOP
Education
North Carolina State University 2006 — 2011
M.Ed Candidate, Training and Development, Completed all coursework: 4.0 GPA
California University of Pennsylvania 1986 — 1990
B.S., Chemistry
Shari DeGrofft Powell Shari DeGrofft Powell's i3 Research Experience October 2009 - December 2012
Job SPM II at AbbVie
Industry Pharmaceuticals
Experience
AbbVie August 2015 - Present
Premier Research September 2013 - August 2015
Premier Research December 2012 - September 2013
i3 Research October 2009 - December 2012
AAIPharma August 2008 - October 2009
AAIPharma August 2008 - July 2009
PRA International October 2007 - July 2008
Paragon Biomedical October 2005 - July 2007
Paragon Biomedical August 2003 - October 2005
Paragon Biomedical August 2002 - August 2003
Skills
EDC, Clinical Trial..., Protocol Development, CRO, GCP, Clinical Research, ICH-GCP, CRF design, Clinical Monitoring, Site Selection, Project Closeout, Project Planning, MS Project, Project Implementation, Project Finance, Project Execution, Project Delivery, Nursing, Women's Health, Oncology, Urology, Nephrology, Infectious Diseases, SOP Development, Process Improvement, Process Development, Training & Development, Training Delivery, Mentoring, Gastroenterology, Dermatology, CNS/Psychology, Phase I - IV, Timeline Management, Global Project..., Quality Management..., Clinical Research..., Clinical Research..., Employee Training, Management, CTMS, Clinical Data Management, Clinical Operations, Clinical Trials, Location Intelligence, Process Simulation, Project Management, SOP development, Clinical Development, Pharmaceutical Industry
Education
Regis University 1996 — 1997
BSN, Nursing
Colorado State University 1992 — 1996
BS, Biology, Anatomy & Neurobiology
AbbVie August 2015 - Present
Premier Research September 2013 - August 2015
Premier Research December 2012 - September 2013
i3 Research October 2009 - December 2012
AAIPharma August 2008 - October 2009
AAIPharma August 2008 - July 2009
PRA International October 2007 - July 2008
Paragon Biomedical October 2005 - July 2007
Paragon Biomedical August 2003 - October 2005
Paragon Biomedical August 2002 - August 2003
Skills
EDC, Clinical Trial..., Protocol Development, CRO, GCP, Clinical Research, ICH-GCP, CRF design, Clinical Monitoring, Site Selection, Project Closeout, Project Planning, MS Project, Project Implementation, Project Finance, Project Execution, Project Delivery, Nursing, Women's Health, Oncology, Urology, Nephrology, Infectious Diseases, SOP Development, Process Improvement, Process Development, Training & Development, Training Delivery, Mentoring, Gastroenterology, Dermatology, CNS/Psychology, Phase I - IV, Timeline Management, Global Project..., Quality Management..., Clinical Research..., Clinical Research..., Employee Training, Management, CTMS, Clinical Data Management, Clinical Operations, Clinical Trials, Location Intelligence, Process Simulation, Project Management, SOP development, Clinical Development, Pharmaceutical Industry
Education
Regis University 1996 — 1997
BSN, Nursing
Colorado State University 1992 — 1996
BS, Biology, Anatomy & Neurobiology
Sue Mellberg's i3 Research Experience 1999 - 2003
Job Independent Consultant
Industry Pharmaceuticals
Experience
Mellberg & Associates 2009 - Present
TorreyPines Therapeutics 2004 - 2009
i3 Research 1999 - 2003
Worldwide Clinical Trials 1997 - 1999
Marion Laboratories 1986 - 1997
Education
Bishop Clarkson School of Nursing 1970 — 1973
RN
Baker University
MBA
Mellberg & Associates 2009 - Present
TorreyPines Therapeutics 2004 - 2009
i3 Research 1999 - 2003
Worldwide Clinical Trials 1997 - 1999
Marion Laboratories 1986 - 1997
Education
Bishop Clarkson School of Nursing 1970 — 1973
RN
Baker University
MBA
Martina Gecikova Martina Gecikova's i3 Research Experience January 2007 - December 2009
Job SSUA II at ICON plc
Industry Pharmaceuticals
Experience
ICON plc August 2014 - Present
ICON plc September 2013 - August 2014
ICON plc January 2013 - August 2013
PharmaNet/i3 January 2010 - December 2012
i3 research January 2007 - December 2009
Sandoz February 2000 - November 2005
PLIVA July 1998 - February 2000
Skills
ICH-GCP, Clinical Trials, Protocol, Clinical Monitoring, CRO, GCP, Oncology, Pharmaceutical Industry, Regulatory Submissions, Clinical Development, Rheumatology, Endocrinology, Diabetes, Regulatory Affairs, Infectious Diseases, Neurology
Education
Pharmaceutical faculty of Comenius University Bratislava, Slovakia 1989 — 1994
Master's degree
ICON plc August 2014 - Present
ICON plc September 2013 - August 2014
ICON plc January 2013 - August 2013
PharmaNet/i3 January 2010 - December 2012
i3 research January 2007 - December 2009
Sandoz February 2000 - November 2005
PLIVA July 1998 - February 2000
Skills
ICH-GCP, Clinical Trials, Protocol, Clinical Monitoring, CRO, GCP, Oncology, Pharmaceutical Industry, Regulatory Submissions, Clinical Development, Rheumatology, Endocrinology, Diabetes, Regulatory Affairs, Infectious Diseases, Neurology
Education
Pharmaceutical faculty of Comenius University Bratislava, Slovakia 1989 — 1994
Master's degree
Colleen O'Gorman Colleen O'Gorman's i3 Research Experience February 2011 - January 2012
Job Study Startup Manager
Industry Pharmaceuticals
Experience
inVentiv Health Clinical January 2015 - Present
PharmaNet/i3 November 2011 - Present
inVentiv Health Clinical 2011 - 2013
i3 Research February 2011 - January 2012
inVentiv Clinical Solutions September 2009 - January 2011
Eli Lilly and Company March 2008 - September 2009
Barker Law Offices August 2005 - February 2008
Skills
Clinical Trials, Clinical Research, GCP, CRO, CTMS, Clinical Development, Oncology, EDC, Pharmaceutical Industry, ICH-GCP, Clinical Monitoring, Regulatory Submissions, Sop, Regulatory Affairs, Clinical Data Management, Medical Writing, Pharmacovigilance
Education
Indiana University-Purdue University at Indianapolis 2001 — 2004
BS, Psychology
Daemen College 1999 — 2001
PT
inVentiv Health Clinical January 2015 - Present
PharmaNet/i3 November 2011 - Present
inVentiv Health Clinical 2011 - 2013
i3 Research February 2011 - January 2012
inVentiv Clinical Solutions September 2009 - January 2011
Eli Lilly and Company March 2008 - September 2009
Barker Law Offices August 2005 - February 2008
Skills
Clinical Trials, Clinical Research, GCP, CRO, CTMS, Clinical Development, Oncology, EDC, Pharmaceutical Industry, ICH-GCP, Clinical Monitoring, Regulatory Submissions, Sop, Regulatory Affairs, Clinical Data Management, Medical Writing, Pharmacovigilance
Education
Indiana University-Purdue University at Indianapolis 2001 — 2004
BS, Psychology
Daemen College 1999 — 2001
PT
Maria Terinoni-Mulvey Maria Terinoni-Mulvey's i3 Research Experience September 2009 - February 2012
Job Senior Research Clinical Associate/i3 Research
Industry Pharmaceuticals
Experience
Forest Laboratories Institute, Inc. August 2011 - Present
i3 Research September 2009 - February 2012
ICON Medical Imaging (IMI) October 2008 - June 2009
Novartis Pharmaceuticals January 1997 - October 2008
Bracco Diagnostics 1994 - 1996
Carter Wallace 1993 - 1994
Belmont Center 1991 - 1993
AAA Video Distributors 1988 - 1991
Skills
Oncology, CTMS, Clinical Trials, Clinical Research, Pharmaceutical Industry, Cardiology, EDC, CRO, Clinical Monitoring, Sop, Diabetes, Neurology, FDA, Protocol, Dermatology, Regulatory Submissions, Endocrinology, IRB, Pharmaceutics, Biotechnology, Medical Writing, Pharmacovigilance, Regulatory Affairs, Data Management, GCP, Clinical Development
Education
Owens Institute of Massage Therapy 1996 — 1997
Certification, Massage Therapy
Holy Family University 1987 — 1991
BA, Pschology
Forest Laboratories Institute, Inc. August 2011 - Present
i3 Research September 2009 - February 2012
ICON Medical Imaging (IMI) October 2008 - June 2009
Novartis Pharmaceuticals January 1997 - October 2008
Bracco Diagnostics 1994 - 1996
Carter Wallace 1993 - 1994
Belmont Center 1991 - 1993
AAA Video Distributors 1988 - 1991
Skills
Oncology, CTMS, Clinical Trials, Clinical Research, Pharmaceutical Industry, Cardiology, EDC, CRO, Clinical Monitoring, Sop, Diabetes, Neurology, FDA, Protocol, Dermatology, Regulatory Submissions, Endocrinology, IRB, Pharmaceutics, Biotechnology, Medical Writing, Pharmacovigilance, Regulatory Affairs, Data Management, GCP, Clinical Development
Education
Owens Institute of Massage Therapy 1996 — 1997
Certification, Massage Therapy
Holy Family University 1987 — 1991
BA, Pschology
Dale Klous Dale Klous's i3 Research Experience January 1999 - January 2006
Job Head of Clinical Studies at Coloplast
Industry Medical Devices
Experience
Coloplast August 2013 - Present
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) September 2006 - August 2013
i3 Research January 1999 - January 2006
Datalog January 1997 - January 1999
Skills
FDA, Clinical Trials, Clinical Development, Medical Devices, Regulatory Affairs, Clinical Research, Lifesciences, NDA, CRF design, CTMS, Drug Development, Biomarkers, Biostatistics, GCP
Education
Concordia College
Bachelor's degree, Organizational Leadership
Coloplast August 2013 - Present
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) September 2006 - August 2013
i3 Research January 1999 - January 2006
Datalog January 1997 - January 1999
Skills
FDA, Clinical Trials, Clinical Development, Medical Devices, Regulatory Affairs, Clinical Research, Lifesciences, NDA, CRF design, CTMS, Drug Development, Biomarkers, Biostatistics, GCP
Education
Concordia College
Bachelor's degree, Organizational Leadership
Serene Redd Mitchell Serene Redd Mitchell's i3 Research Experience September 2005 - May 2006
Job Administrative Associate
Industry Telecommunications
Experience
Apex Systems March 2014 - June 2014
Express Employment Professionals - Raleigh, NC October 2013 - January 2014
SAFEchild, Inc February 2012 - January 2013
Kelly Services September 2006 - November 2006
i3 Research September 2005 - May 2006
CBS Payroll Service, Inc. April 2001 - May 2001
IUA Staffing October 2000 - December 2000
N Touch Wireless and Communications October 1997 - September 2000
Skills
Data Entry, Invoicing, Filing, Spreadsheets, Outlook, Fax, Microsoft Office, Microsoft Excel, Customer Service, PowerPoint, Microsoft Word, Sales, Typing, Receptionist Duties, Event Planning
Education
Ashford University 2009 — 2010
Health/Health Care Administration/Management
Associated Technical College-San Diego 2009 — 2010
Diploma, Business Administration
Apex Systems March 2014 - June 2014
Express Employment Professionals - Raleigh, NC October 2013 - January 2014
SAFEchild, Inc February 2012 - January 2013
Kelly Services September 2006 - November 2006
i3 Research September 2005 - May 2006
CBS Payroll Service, Inc. April 2001 - May 2001
IUA Staffing October 2000 - December 2000
N Touch Wireless and Communications October 1997 - September 2000
Skills
Data Entry, Invoicing, Filing, Spreadsheets, Outlook, Fax, Microsoft Office, Microsoft Excel, Customer Service, PowerPoint, Microsoft Word, Sales, Typing, Receptionist Duties, Event Planning
Education
Ashford University 2009 — 2010
Health/Health Care Administration/Management
Associated Technical College-San Diego 2009 — 2010
Diploma, Business Administration
Melissa Dean Melissa Dean's i3 Research Experience February 2008 - December 2008
Job Senior Clinical Research Associate at Covance
Industry Pharmaceuticals
Experience
Covance May 2015 - Present
Worldwide Clinical Trials April 2014 - May 2015
PPD April 2013 - April 2014
Covance January 2013 - April 2013
PPD October 2011 - January 2013
Merck November 2009 - October 2011
Schering-Plough Research Institute December 2008 - November 2009
i3 Research February 2008 - December 2008
i3 Research July 2006 - February 2008
i3 Research April 2004 - July 2006
Skills
CTMS, GCP, EDC, Clinical Trials, CRO, Therapeutic Areas, Pharmaceutical Industry, ICH-GCP, Regulatory Submissions, Clinical Data Management, Clinical Monitoring, 21 CFR Part 11, Neurology, Oracle Clinical, Psychiatry, Clinical Operations, Drug Development, Gastroenterology, FDA, Urology, Protocol, Cancer, CRF design, Regulatory Requirements, Trial Management, Inform, Sop, Pharmacology, Infectious Diseases, Data Management, Neuroscience, Pharmaceutics, Lifesciences, Life Sciences, SOP
Education
Fairleigh Dickinson University 1997 — 2000
BS, Business Management
Covance May 2015 - Present
Worldwide Clinical Trials April 2014 - May 2015
PPD April 2013 - April 2014
Covance January 2013 - April 2013
PPD October 2011 - January 2013
Merck November 2009 - October 2011
Schering-Plough Research Institute December 2008 - November 2009
i3 Research February 2008 - December 2008
i3 Research July 2006 - February 2008
i3 Research April 2004 - July 2006
Skills
CTMS, GCP, EDC, Clinical Trials, CRO, Therapeutic Areas, Pharmaceutical Industry, ICH-GCP, Regulatory Submissions, Clinical Data Management, Clinical Monitoring, 21 CFR Part 11, Neurology, Oracle Clinical, Psychiatry, Clinical Operations, Drug Development, Gastroenterology, FDA, Urology, Protocol, Cancer, CRF design, Regulatory Requirements, Trial Management, Inform, Sop, Pharmacology, Infectious Diseases, Data Management, Neuroscience, Pharmaceutics, Lifesciences, Life Sciences, SOP
Education
Fairleigh Dickinson University 1997 — 2000
BS, Business Management
Yasmin Haider Yasmin Haider's i3 Research Experience October 2010 - January 2011
Job Regulatory Manager Cancer Research Office, University of Massachusetts Medical School
Industry Research
Experience
University of Massachusetts Medical School August 2011 - Present
Millennium Pharmaceuticals May 2011 - July 2011
Biogen Idec January 2011 - May 2011
i3 Research October 2010 - January 2011
Pfizer Inc. (Formerly Wyeth) September 2008 - October 2010
University of Massachusetts May 2006 - September 2008
UMass Memorial Hospital July 2004 - May 2006
Geisinger Health System June 1998 - July 2004
Skills
GLP, Hematology, Clinical Research, CTMS, Lifesciences, Biotechnology, Pharmaceutical Industry, Oncology Trials (Phase..., GCP, TMF management &..., Regulatory Submissions, SOP's, In-House monitoring, Oncology, Cancer, Clinical Trials, Clinical Development, Regulatory Affairs, Sop, Clinical Data Management, FDA, CRO, Protocol, Microbiology, IND, IRB, Laboratory, Therapeutic Areas, ICH-GCP
Education
Misericordia University 1995 — 1998
BS, Medical Technology
Karachi University 1985 — 1989
BS, Microbiology & Chemistry
University of Massachusetts Medical School August 2011 - Present
Millennium Pharmaceuticals May 2011 - July 2011
Biogen Idec January 2011 - May 2011
i3 Research October 2010 - January 2011
Pfizer Inc. (Formerly Wyeth) September 2008 - October 2010
University of Massachusetts May 2006 - September 2008
UMass Memorial Hospital July 2004 - May 2006
Geisinger Health System June 1998 - July 2004
Skills
GLP, Hematology, Clinical Research, CTMS, Lifesciences, Biotechnology, Pharmaceutical Industry, Oncology Trials (Phase..., GCP, TMF management &..., Regulatory Submissions, SOP's, In-House monitoring, Oncology, Cancer, Clinical Trials, Clinical Development, Regulatory Affairs, Sop, Clinical Data Management, FDA, CRO, Protocol, Microbiology, IND, IRB, Laboratory, Therapeutic Areas, ICH-GCP
Education
Misericordia University 1995 — 1998
BS, Medical Technology
Karachi University 1985 — 1989
BS, Microbiology & Chemistry
Vicky Leamy's i3 Research Experience January 2006 - December 2011
Job Therapeutic Strategy Lead at Quintiles
Industry Pharmaceuticals
Experience
Quintiles December 2011 - Present
i3 Research January 2006 - December 2011
Vical June 2002 - December 2005
Advanced Biologics January 2000 - March 2002
Skills
Vaccines, Clinical Research, GCP, Animal Models, Data Management, Clinical Monitoring, Clinical Development, Immunology, Clinical Trials, International Management, Line Management, Talent Development, Technical Writing, GLP, Infectious Diseases, Antibiotics, Disease Prevention, Regulatory Submissions, EDC, Biotechnology, CTMS, Drug Development, CRO, Oncology, Therapeutic Areas, Pharmaceutical Industry, Talent Management, ICH-GCP, Antibacterial, Preventive Medicine
Education
Emory University 1997 — 1999
MPH, Public Health
Millersville University of Pennsylvania 1994 — 1996
BA, International Studies
The American University in Cairo 1995 — 1995
Intensive Arabic Studies
Quintiles December 2011 - Present
i3 Research January 2006 - December 2011
Vical June 2002 - December 2005
Advanced Biologics January 2000 - March 2002
Skills
Vaccines, Clinical Research, GCP, Animal Models, Data Management, Clinical Monitoring, Clinical Development, Immunology, Clinical Trials, International Management, Line Management, Talent Development, Technical Writing, GLP, Infectious Diseases, Antibiotics, Disease Prevention, Regulatory Submissions, EDC, Biotechnology, CTMS, Drug Development, CRO, Oncology, Therapeutic Areas, Pharmaceutical Industry, Talent Management, ICH-GCP, Antibacterial, Preventive Medicine
Education
Emory University 1997 — 1999
MPH, Public Health
Millersville University of Pennsylvania 1994 — 1996
BA, International Studies
The American University in Cairo 1995 — 1995
Intensive Arabic Studies
Frederick Cieri Frederick Cieri's i3 Research Experience April 2011 - February 2012
Job Systems Programmer Analyst at Chiltern
Industry Pharmaceuticals
Experience
FACtotum Data Consulting SAS Systems Programmer AnalystChilternMarch 2014 - Present
CSC January 2013 - March 2014
BioMarin Pharmaceutical Inc. 2014 - 2014
BioMarin Pharmaceutical Inc. 2014 - 2014
BioMarin Pharmaceutical Inc. 2014 - 2014
BioMarin Pharmaceutical Inc. 2014 - 2014
Tech Data Services February 2012 - August 2012
i3 Research April 2011 - February 2012
Merck April 2000 - December 2010
Rhone-Poulenc Rorer January 1997 - April 2000
Skills
SAS, Pharmaceuticals, SAS programming, Clinical Research, Macro, Clinical Trials, Biostatistics, CRO, Oncology, Validation, CDISC, Pharmaceutics, Microsoft Excel, Biotechnology
Education
Temple University 1994 — 1996
MS, Statistics
Drexel University 1991 — 1994
MBA, Quality Science
Temple University 1986 — 1990
BS, Mathematical Economics
FACtotum Data Consulting SAS Systems Programmer AnalystChilternMarch 2014 - Present
CSC January 2013 - March 2014
BioMarin Pharmaceutical Inc. 2014 - 2014
BioMarin Pharmaceutical Inc. 2014 - 2014
BioMarin Pharmaceutical Inc. 2014 - 2014
BioMarin Pharmaceutical Inc. 2014 - 2014
Tech Data Services February 2012 - August 2012
i3 Research April 2011 - February 2012
Merck April 2000 - December 2010
Rhone-Poulenc Rorer January 1997 - April 2000
Skills
SAS, Pharmaceuticals, SAS programming, Clinical Research, Macro, Clinical Trials, Biostatistics, CRO, Oncology, Validation, CDISC, Pharmaceutics, Microsoft Excel, Biotechnology
Education
Temple University 1994 — 1996
MS, Statistics
Drexel University 1991 — 1994
MBA, Quality Science
Temple University 1986 — 1990
BS, Mathematical Economics
Susan Keegan Susan Keegan's i3 Research Experience November 2000 - July 2006
Job Retired Regional Clinical Research Associate
Industry Pharmaceuticals
Experience
ReSearch Pharmaceutical Services November 2009 - 2011
PPD October 2006 - October 2008
ICON Clinical Research July 2006 - October 2006
i3 Research November 2000 - July 2006
PAREXEL October 1996 - November 2000
Organon 1994 - 1996
Coromed, Inc. September 1991 - November 1994
Albany Medical College 1984 - 1991
Albany Medical College 1984 - 1991
Beth Israel Hospital 1973 - 1976
Skills
Clinical Trials, Clinical Research, Clinical Monitoring, GCP
Education
Berkshire Botanical Garden/Berkshire Community College 2012 — 2013
Level1 Horticulture Certificate, Horticulture
Harvard University 1974 — 1974
Radiation Safety
Wheaton College (MA) 1971 — 1973
BA, Biology
Northeastern University 1968 — 1971
Physical Education
ReSearch Pharmaceutical Services November 2009 - 2011
PPD October 2006 - October 2008
ICON Clinical Research July 2006 - October 2006
i3 Research November 2000 - July 2006
PAREXEL October 1996 - November 2000
Organon 1994 - 1996
Coromed, Inc. September 1991 - November 1994
Albany Medical College 1984 - 1991
Albany Medical College 1984 - 1991
Beth Israel Hospital 1973 - 1976
Skills
Clinical Trials, Clinical Research, Clinical Monitoring, GCP
Education
Berkshire Botanical Garden/Berkshire Community College 2012 — 2013
Level1 Horticulture Certificate, Horticulture
Harvard University 1974 — 1974
Radiation Safety
Wheaton College (MA) 1971 — 1973
BA, Biology
Northeastern University 1968 — 1971
Physical Education
Robin Barber, PMP's i3 Research Experience October 2005 - February 2006
Job Director, IxR Technology at Merge Healthcare
Industry Hospital & Health Care
Experience
Merge Healthcare February 2014 - Present
Merge Healthcare June 2010 - February 2014
Merge Healthcare November 2006 - June 2010
etrials Worldwide May 2006 - November 2006
INC Research February 2006 - May 2006
i3 Research October 2005 - February 2006
i3 Research June 2004 - October 2005
i3 Research June 2002 - June 2004
Skills
Healthcare Information..., Healthcare, EHR, Hospitals, Medical Devices, Project Management, Program Management, SDLC, Access, Management, Quality Assurance, Analysis, Testing, Databases, Clinical Trials, Data Management, Pharmaceutical Industry
Education
Project Management Academy (PMA) 2013 — 2013
PMP Certification 27Jul2013, PMP Prep Boot Camp
Johnston County Community College 2010 — 2010
Notary Public
Johnston Community College 2007 — 2007
Project Management Fundamentals
Johnston Community College 2003 — 2003
Planning, Executing and Controlling (Project Management Principles II)
Johnston Community College 2003 — 2003
Introduction and Overview of Project Management (Project Management Principles I)
Fairfield Career Center 1997 — 1998
Medical Assistaning
Mercer County Career Center 1990 — 1992
Business and Marketing Technology
Merge Healthcare February 2014 - Present
Merge Healthcare June 2010 - February 2014
Merge Healthcare November 2006 - June 2010
etrials Worldwide May 2006 - November 2006
INC Research February 2006 - May 2006
i3 Research October 2005 - February 2006
i3 Research June 2004 - October 2005
i3 Research June 2002 - June 2004
Skills
Healthcare Information..., Healthcare, EHR, Hospitals, Medical Devices, Project Management, Program Management, SDLC, Access, Management, Quality Assurance, Analysis, Testing, Databases, Clinical Trials, Data Management, Pharmaceutical Industry
Education
Project Management Academy (PMA) 2013 — 2013
PMP Certification 27Jul2013, PMP Prep Boot Camp
Johnston County Community College 2010 — 2010
Notary Public
Johnston Community College 2007 — 2007
Project Management Fundamentals
Johnston Community College 2003 — 2003
Planning, Executing and Controlling (Project Management Principles II)
Johnston Community College 2003 — 2003
Introduction and Overview of Project Management (Project Management Principles I)
Fairfield Career Center 1997 — 1998
Medical Assistaning
Mercer County Career Center 1990 — 1992
Business and Marketing Technology
Marina Gunning Marina Gunning's i3 Research Experience June 2002 - February 2005
Job Sr Project Manager Global Project Management at PPD
Industry Pharmaceuticals
Experience
PPD May 2013 - Present
Novartis 2010 - October 2012
Novartis Pharmaceuticals February 2005 - July 2010
i3 Research June 2002 - February 2005
Organon Pharmaceuticals 1991 - 2002
Skills
Clinical Trials, CRO, Clinical Research, Pharmaceutical Industry, CTMS, Clinical Development, Clinical Monitoring, EDC, Oncology, GCP, Project Management, Biotechnology, Clinical Study Design, Infectious Diseases, ICH-GCP, Regulatory Affairs, Clinical Data Management, Drug Development, FDA, Regulatory Submissions, Clinical Operations, Protocol, Biopharmaceuticals, Trial Management, Medical Writing, Pharmacovigilance, Medical Affairs, Sop, Neurology, Hematology, Immunology, Rheumatology, Gastroenterology, IVR, Vendor Management, Vaccines, Patient Recruitment, Pharmaceutics, Endocrinology, Oracle Clinical, IND, Dermatology, Diabetes, Lifesciences, ePRISM, Cardiology, Pharmacology, Regulatory Requirements, Global Clinical Trial..., Clinical Trial Budget...
Education
Villanova University 2012 — 2012
Master Certification, Project Management, A
Villanova University 2011 — 2012
Essential Certification, Project Management
The George Washington University - School of Business 2008 — 2008
Essential Cetification, Managing Projects
County College of Morris 1981 — 1984
AA, Biology
University of Medicine and Dentistry of New Jersey
Surgical Preceptorship, Anesthesiology
PPD May 2013 - Present
Novartis 2010 - October 2012
Novartis Pharmaceuticals February 2005 - July 2010
i3 Research June 2002 - February 2005
Organon Pharmaceuticals 1991 - 2002
Skills
Clinical Trials, CRO, Clinical Research, Pharmaceutical Industry, CTMS, Clinical Development, Clinical Monitoring, EDC, Oncology, GCP, Project Management, Biotechnology, Clinical Study Design, Infectious Diseases, ICH-GCP, Regulatory Affairs, Clinical Data Management, Drug Development, FDA, Regulatory Submissions, Clinical Operations, Protocol, Biopharmaceuticals, Trial Management, Medical Writing, Pharmacovigilance, Medical Affairs, Sop, Neurology, Hematology, Immunology, Rheumatology, Gastroenterology, IVR, Vendor Management, Vaccines, Patient Recruitment, Pharmaceutics, Endocrinology, Oracle Clinical, IND, Dermatology, Diabetes, Lifesciences, ePRISM, Cardiology, Pharmacology, Regulatory Requirements, Global Clinical Trial..., Clinical Trial Budget...
Education
Villanova University 2012 — 2012
Master Certification, Project Management, A
Villanova University 2011 — 2012
Essential Certification, Project Management
The George Washington University - School of Business 2008 — 2008
Essential Cetification, Managing Projects
County College of Morris 1981 — 1984
AA, Biology
University of Medicine and Dentistry of New Jersey
Surgical Preceptorship, Anesthesiology
Toya Lennon Toya Lennon's i3 Research Experience August 2001 - August 2004
Job Clinical Study Manager at Grifols
Industry Pharmaceuticals
Experience
Grifols November 2014 - Present
Grifols November 2012 - November 2014
Grifols December 2008 - November 2012
Aderex April 2008 - September 2008
RTI Health Solutions September 2006 - April 2008
Lineberry Research September 2004 - September 2006
i3 Research August 2001 - August 2004
PPD October 1999 - August 2001
Hospital, Clinic, and Agency 1997 - 2001
Skills
CRO, Clinical Trials, Pharmaceutical Industry, GCP, Clinical Development, CTMS, ICH-GCP, Clinical Monitoring, EDC, Biotechnology, SOP, Therapeutic Areas
Education
Howard University 1992 — 1996
Bachelor of Science (B.S.), Registered Nursing/Registered Nurse
Grifols November 2014 - Present
Grifols November 2012 - November 2014
Grifols December 2008 - November 2012
Aderex April 2008 - September 2008
RTI Health Solutions September 2006 - April 2008
Lineberry Research September 2004 - September 2006
i3 Research August 2001 - August 2004
PPD October 1999 - August 2001
Hospital, Clinic, and Agency 1997 - 2001
Skills
CRO, Clinical Trials, Pharmaceutical Industry, GCP, Clinical Development, CTMS, ICH-GCP, Clinical Monitoring, EDC, Biotechnology, SOP, Therapeutic Areas
Education
Howard University 1992 — 1996
Bachelor of Science (B.S.), Registered Nursing/Registered Nurse
Akshay Sharma Akshay Sharma's i3 Research Experience September 2010 - September 2011
Job Leading Engineering @ Human API We are hiring!
Industry Computer Software
Experience
Human API September 2014 - Present
Ensighten May 2013 - September 2014
PixelSimple October 2011 - October 2012
i3 Research September 2010 - September 2011
3M 2004 - 2010
Cognizant Technology Solutions September 2002 - May 2004
Skills
Java Enterprise Edition, Software Development, Integration, Architectures, Data Analysis, Big Data, Scalability, Management, Flex, Web Analytics, Product Development, Agile Methodologies, SQL, XML, Java
Education
Visvesvaraya Technological University 1998 — 2002
B.E, Information Science and Engineering
Kendriya Vidyalaya 1986 — 1998
Human API September 2014 - Present
Ensighten May 2013 - September 2014
PixelSimple October 2011 - October 2012
i3 Research September 2010 - September 2011
3M 2004 - 2010
Cognizant Technology Solutions September 2002 - May 2004
Skills
Java Enterprise Edition, Software Development, Integration, Architectures, Data Analysis, Big Data, Scalability, Management, Flex, Web Analytics, Product Development, Agile Methodologies, SQL, XML, Java
Education
Visvesvaraya Technological University 1998 — 2002
B.E, Information Science and Engineering
Kendriya Vidyalaya 1986 — 1998
Chelsea Malek Chelsea Malek's i3 Research Experience July 2010 - January 2012
Job Clinical Research Associate at PPD
Industry Pharmaceuticals
Experience
PPD April 2015 - Present
PPD March 2014 - March 2015
PPD January 2012 - March 2014
i3 Research July 2010 - January 2012
Skills
Microsoft Excel, Microsoft Word, PowerPoint, Outlook, RightFax, Clinical Research, CRO, GCP, Clinical Administration, FDA, Sop
Education
East Carolina University 2006 — 2010
BS, Health Information/Medical Records Administration/Administrator
East Carolina University 2006 — 2010
Health Information Management
PPD April 2015 - Present
PPD March 2014 - March 2015
PPD January 2012 - March 2014
i3 Research July 2010 - January 2012
Skills
Microsoft Excel, Microsoft Word, PowerPoint, Outlook, RightFax, Clinical Research, CRO, GCP, Clinical Administration, FDA, Sop
Education
East Carolina University 2006 — 2010
BS, Health Information/Medical Records Administration/Administrator
East Carolina University 2006 — 2010
Health Information Management
Jason Russak's i3 Research Experience June 2010 - December 2011
Job Sr. Manager, Business Process at Biogen
Industry Biotechnology
Experience
Biogen March 2015 - Present
Flemington-Raritan First Aid and Rescue Squad January 2000 - Present
Biogen Idec July 2014 - March 2015
Biogen Idec April 2013 - July 2014
Biogen Idec December 2011 - April 2013
i3 Research June 2010 - December 2011
Medway Café June 2009 - August 2010
Dana-Farber Cancer Institute August 2007 - June 2010
Whitehouse Rescue Squad June 2005 - December 2008
Beth Israel Deaconess Medical Center February 2007 - August 2007
Skills
Clinical Trials, Clinical Development, CTMS, CRO, EDC, Clinical Research, Protocol, Biotechnology, FDA, GCP, Quality Assurance, IMP Management, GCP Inspection Readiness, Project Management, Lifesciences, Sop, Oncology, Process Improvement, Process Management, Process Optimization, SOP development, Quality Improvement, Business Process Mapping, Visio, Lean Six Sigma, Green Belt, Yellow Belt, Process Excellence, Vendor Management, ICH-GCP, Document Management, Clinical Monitoring, Neurology, Multiple Sclerosis, Clinical Study Design, SOP authoring, Change Management, Clinical Operations, Strategic Partnerships, SOP
Education
Worcester Polytechnic Institute 2014 — 2018
Master of Business Administration (M.B.A.)
Boston University School of Medicine 2005 — 2008
Master of Arts, Medical Sciences2008
Northeastern University 2001 — 2005
BS, Biology
Biogen March 2015 - Present
Flemington-Raritan First Aid and Rescue Squad January 2000 - Present
Biogen Idec July 2014 - March 2015
Biogen Idec April 2013 - July 2014
Biogen Idec December 2011 - April 2013
i3 Research June 2010 - December 2011
Medway Café June 2009 - August 2010
Dana-Farber Cancer Institute August 2007 - June 2010
Whitehouse Rescue Squad June 2005 - December 2008
Beth Israel Deaconess Medical Center February 2007 - August 2007
Skills
Clinical Trials, Clinical Development, CTMS, CRO, EDC, Clinical Research, Protocol, Biotechnology, FDA, GCP, Quality Assurance, IMP Management, GCP Inspection Readiness, Project Management, Lifesciences, Sop, Oncology, Process Improvement, Process Management, Process Optimization, SOP development, Quality Improvement, Business Process Mapping, Visio, Lean Six Sigma, Green Belt, Yellow Belt, Process Excellence, Vendor Management, ICH-GCP, Document Management, Clinical Monitoring, Neurology, Multiple Sclerosis, Clinical Study Design, SOP authoring, Change Management, Clinical Operations, Strategic Partnerships, SOP
Education
Worcester Polytechnic Institute 2014 — 2018
Master of Business Administration (M.B.A.)
Boston University School of Medicine 2005 — 2008
Master of Arts, Medical Sciences2008
Northeastern University 2001 — 2005
BS, Biology
Katy Mulleady's i3 Research Experience February 2011 - May 2011
Job Associate Global Regulatory and Start Up Director at Quintiles
Industry Pharmaceuticals
Experience
Quintiles October 2014 - Present
Quintiles June 2012 - October 2014
Novella Clinical, Inc. May 2011 - May 2012
i3 Research February 2011 - May 2011
i3 Research August 2009 - February 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" August 2008 - August 2009
i3 Research August 2007 - August 2008
PPD January 2005 - August 2007
Integrated Laboratory Systems January 2004 - January 2005
Skills
Clinical Trials, CRO, GCP, CTMS, Pharmaceutical Industry, Clinical Development, EDC, ICH-GCP, Oncology, Regulatory Affairs
Education
Durham Technical Community College 2004 — 2005
Certificate, Clinical Research
Greensboro College 1999 — 2003
BS, Biology, Chemistry, Religion
Quintiles October 2014 - Present
Quintiles June 2012 - October 2014
Novella Clinical, Inc. May 2011 - May 2012
i3 Research February 2011 - May 2011
i3 Research August 2009 - February 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" August 2008 - August 2009
i3 Research August 2007 - August 2008
PPD January 2005 - August 2007
Integrated Laboratory Systems January 2004 - January 2005
Skills
Clinical Trials, CRO, GCP, CTMS, Pharmaceutical Industry, Clinical Development, EDC, ICH-GCP, Oncology, Regulatory Affairs
Education
Durham Technical Community College 2004 — 2005
Certificate, Clinical Research
Greensboro College 1999 — 2003
BS, Biology, Chemistry, Religion
Ani Shkodrova Ani Shkodrova's i3 Research Experience October 2005 - October 2008
Job Head of Monitoring at Pfizer
Industry Pharmaceuticals
Experience
Pfizer April 2011 - Present
Pfizer January 2009 - April 2011
Quintiles October 2008 - December 2008
i3 Research October 2005 - October 2008
Skills
Clinical Trials, Clinical Monitoring, ICH-GCP, CTMS, GCP, Pharmacovigilance, Pharmaceutical Industry, CRO, Therapeutic Areas, Regulatory Submissions
Education
Medicinski universitet - Sofia 1994 — 2000
Master, Medicine
Pfizer April 2011 - Present
Pfizer January 2009 - April 2011
Quintiles October 2008 - December 2008
i3 Research October 2005 - October 2008
Skills
Clinical Trials, Clinical Monitoring, ICH-GCP, CTMS, GCP, Pharmacovigilance, Pharmaceutical Industry, CRO, Therapeutic Areas, Regulatory Submissions
Education
Medicinski universitet - Sofia 1994 — 2000
Master, Medicine
Jean Abbott, MT (ASCP) Jean Abbott, MT (ASCP)'s i3 Research Experience October 2010 - February 2011
Job Clinical Research Associate at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL August 2012 - Present
Execupharm October 2011 - May 2012
Columbia Laboratories April 2011 - July 2011
i3 Research October 2010 - February 2011
Cu-Tech LLC August 2006 - May 2009
Private Pediatric Practice August 1988 - January 1996
St. Michael's Medical Center September 1982 - February 1988
Skills
Clinical Trials, Clinical, Clinical Research, Pharmaceuticals, CRO, Writing, Excel, Word, GCP, Biostatistics, Compliance, Research, Documentation, FDA, Therapeutic areas, Clinical Monitoring, Quality Assurance, EDC, Infectious Diseases, Diagnostics, QC, Medical Terminology, Clinical Trial..., Clinical Data Management, ICH-GCP, Pharmacovigilance, Clinical Development, Protocol Development, Medical Writing, CTMS, Pharmaceutical Industry, Regulatory Submissions, Protocol, Therapeutic Areas, Microsoft Excel, Sop, Regulatory Affairs
Education
Drexel University College of Medicine 2008 — 2011
MS, Clinical Research and Management
SYRACUSE UNIVERSITY, Utica Campus 1979 — 1982
BS, Medical Technology
PAREXEL August 2012 - Present
Execupharm October 2011 - May 2012
Columbia Laboratories April 2011 - July 2011
i3 Research October 2010 - February 2011
Cu-Tech LLC August 2006 - May 2009
Private Pediatric Practice August 1988 - January 1996
St. Michael's Medical Center September 1982 - February 1988
Skills
Clinical Trials, Clinical, Clinical Research, Pharmaceuticals, CRO, Writing, Excel, Word, GCP, Biostatistics, Compliance, Research, Documentation, FDA, Therapeutic areas, Clinical Monitoring, Quality Assurance, EDC, Infectious Diseases, Diagnostics, QC, Medical Terminology, Clinical Trial..., Clinical Data Management, ICH-GCP, Pharmacovigilance, Clinical Development, Protocol Development, Medical Writing, CTMS, Pharmaceutical Industry, Regulatory Submissions, Protocol, Therapeutic Areas, Microsoft Excel, Sop, Regulatory Affairs
Education
Drexel University College of Medicine 2008 — 2011
MS, Clinical Research and Management
SYRACUSE UNIVERSITY, Utica Campus 1979 — 1982
BS, Medical Technology
Cynthia L. Martinez, RN Cynthia L. Martinez, RN's i3 Research Experience 2001 - 2007
Job Clinical Research Associate III at INC Research
Industry Pharmaceuticals
Experience
INC Research April 2013 - Present
Contract Clinical Data and Project Manager 2012 - April 2013
Independent Contractor February 2012 - June 2012
Array BioPharma January 2009 - June 2011
Array BioPharma 2007 - 2009
i3 Research 2001 - 2007
MDS Pharma Services 1999 - 2001
Longmont Medical Research Network 1996 - 1999
Skills
Medidata, Webforms, SAS add-in, Oncology: Breast cancer..., CNS: schizophernia,..., Geniturinary: BPH and..., Pulmonary: COPD, Rheumatology:..., Gastroenterology: GERD,..., Endocrine/Metabolism:..., Dermatology: Alopecia..., Use of FTP, VPN and..., Clinical Trials, GCP, Clinical Development, Biotechnology, EDC
Education
Front Range Community College
Associate of Arts and Sciences (A.A.S.), Registered Nursing/Registered Nurse
INC Research April 2013 - Present
Contract Clinical Data and Project Manager 2012 - April 2013
Independent Contractor February 2012 - June 2012
Array BioPharma January 2009 - June 2011
Array BioPharma 2007 - 2009
i3 Research 2001 - 2007
MDS Pharma Services 1999 - 2001
Longmont Medical Research Network 1996 - 1999
Skills
Medidata, Webforms, SAS add-in, Oncology: Breast cancer..., CNS: schizophernia,..., Geniturinary: BPH and..., Pulmonary: COPD, Rheumatology:..., Gastroenterology: GERD,..., Endocrine/Metabolism:..., Dermatology: Alopecia..., Use of FTP, VPN and..., Clinical Trials, GCP, Clinical Development, Biotechnology, EDC
Education
Front Range Community College
Associate of Arts and Sciences (A.A.S.), Registered Nursing/Registered Nurse
Meredith (Walkley) Chistolini Meredith (Walkley) Chistolini's i3 Research Experience September 2005 - October 2006
Job Management Consultant, Accenture
Industry Management Consulting
Experience
Accenture May 2012 - Present
Crystal CIty Working Parents September 2012 - Present
Bayer CropScience February 2008 - May 2012
Credit Suisse October 2006 - August 2007
i3 Research September 2005 - October 2006
SAS September 2001 - August 2003
PricewaterhouseCoopers February 2001 - July 2003
Skills
Business Strategy, Strategy, Change Management, Process Improvement, Project Management, Management Consulting, Vendor Management, Financial Analysis, Business Analysis, Market Research, Business Process..., Business Transformation, Program Management, Business Intelligence, Product Development, CRM, Management
Education
North Carolina State University 2003 — 2005
Master of Economics
James Madison University 1996 — 2000
BS, Economics
Accenture May 2012 - Present
Crystal CIty Working Parents September 2012 - Present
Bayer CropScience February 2008 - May 2012
Credit Suisse October 2006 - August 2007
i3 Research September 2005 - October 2006
SAS September 2001 - August 2003
PricewaterhouseCoopers February 2001 - July 2003
Skills
Business Strategy, Strategy, Change Management, Process Improvement, Project Management, Management Consulting, Vendor Management, Financial Analysis, Business Analysis, Market Research, Business Process..., Business Transformation, Program Management, Business Intelligence, Product Development, CRM, Management
Education
North Carolina State University 2003 — 2005
Master of Economics
James Madison University 1996 — 2000
BS, Economics
Cyndy Collis Cyndy Collis's i3 Research Experience February 2008 - May 2009
Job Experienced Pharmaceutical Project and Clinical Manager
Industry Pharmaceuticals
Experience
INC Research June 2015 - Present
PAREXEL June 2012 - August 2014
Cytochroma Inc. April 2011 - February 2012
Hospira Inc. 2009 - 2011
i3 Research February 2008 - May 2009
Collis Consultants September 2006 - February 2008
deCODE genetics August 2005 - September 2006
Ovation Pharmaceuticals December 2003 - September 2005
TAP Pharmaceuticals October 1995 - December 2003
TAP Pharmaceuticals 1995 - 2003
Skills
Clinical Development, Oncology, Clinical Trials, CRO, Vendor, Pharmaceuticals, Clinical, Biopharmaceuticals, Pharmaceutics, Pharmaceutical Industry, Clinical Research, Lifesciences, Biotechnology, Infectious Diseases, Regulatory Affairs, CTMS, Cardiology, FDA, Medical Devices, Drug Development, Diabetes, GCP
Education
Elmhurst College 1983 — 1986
BS, Chemistry, Magna Cum Laude
INC Research June 2015 - Present
PAREXEL June 2012 - August 2014
Cytochroma Inc. April 2011 - February 2012
Hospira Inc. 2009 - 2011
i3 Research February 2008 - May 2009
Collis Consultants September 2006 - February 2008
deCODE genetics August 2005 - September 2006
Ovation Pharmaceuticals December 2003 - September 2005
TAP Pharmaceuticals October 1995 - December 2003
TAP Pharmaceuticals 1995 - 2003
Skills
Clinical Development, Oncology, Clinical Trials, CRO, Vendor, Pharmaceuticals, Clinical, Biopharmaceuticals, Pharmaceutics, Pharmaceutical Industry, Clinical Research, Lifesciences, Biotechnology, Infectious Diseases, Regulatory Affairs, CTMS, Cardiology, FDA, Medical Devices, Drug Development, Diabetes, GCP
Education
Elmhurst College 1983 — 1986
BS, Chemistry, Magna Cum Laude
Pradeep Inamdar's i3 Research Experience May 2010 - October 2011
Job Owner, Global Technosoft Resources, Inc.
Industry Computer Software
Experience
Global Technosoft Resources April 2000 - Present
ArisGlobal, LLC February 2005 - November 2011
Salix Pharmaceuticals February 2011 - October 2011
i3 Research May 2010 - October 2011
Nektar Therapeutics March 2011 - September 2011
United Therapeutics July 2010 - July 2011
Roche October 2008 - January 2011
Onyx Pharmaceuticals 2009 - 2010
Cerus January 2008 - April 2008
Amgen 2007 - 2008
Skills
Customer Relations, Vendor Management, New Business Development, Contract Negotiation, Process Improvement, Contract Management, Budgeting, Strategic Planning, Resource Management, Program Management, Team Building, Virtual Teams, SDLC, Project Implementation, Software Development, Pharmaceuticals, Life Sciences, Pharmaceutical Industry, Lifesciences, Analysis, Oracle, Requirements Analysis, Project Planning, Customer Service, Databases, Management, Integration, Budgets, Project Management, Software Project..., Consulting, Cross-functional Team..., Requirements Gathering
Education
Clemson University 1990 — 1992
MS, Computer Science
Clemson University 1988 — 1990
MS, Civil Engineering
Visvesvaraya National Institute of Technology 1982 — 1986
BE, Civil Engineering
Global Technosoft Resources April 2000 - Present
ArisGlobal, LLC February 2005 - November 2011
Salix Pharmaceuticals February 2011 - October 2011
i3 Research May 2010 - October 2011
Nektar Therapeutics March 2011 - September 2011
United Therapeutics July 2010 - July 2011
Roche October 2008 - January 2011
Onyx Pharmaceuticals 2009 - 2010
Cerus January 2008 - April 2008
Amgen 2007 - 2008
Skills
Customer Relations, Vendor Management, New Business Development, Contract Negotiation, Process Improvement, Contract Management, Budgeting, Strategic Planning, Resource Management, Program Management, Team Building, Virtual Teams, SDLC, Project Implementation, Software Development, Pharmaceuticals, Life Sciences, Pharmaceutical Industry, Lifesciences, Analysis, Oracle, Requirements Analysis, Project Planning, Customer Service, Databases, Management, Integration, Budgets, Project Management, Software Project..., Consulting, Cross-functional Team..., Requirements Gathering
Education
Clemson University 1990 — 1992
MS, Computer Science
Clemson University 1988 — 1990
MS, Civil Engineering
Visvesvaraya National Institute of Technology 1982 — 1986
BE, Civil Engineering
Jack Arthur's i3 Research Experience April 2010 - July 2011
Job Associate Director at InVentiv Health
Industry Pharmaceuticals
Experience
inVentiv Health Clinical April 2015 - Present
inVentiv Health Clinical July 2011 - April 2015
i3 Research April 2010 - July 2011
i3 Research December 2006 - April 2011
Fresenius HemoCare July 2005 - December 2006
Pulmonary Consultants 2003 - July 2005
PC3/AmericasDoctor August 1999 - 2003
Skills
Clinical Trials, ICH-GCP, EDC, Clinical Development, Clinical Research, Training, Microsoft Office, Medical Devices, Sop, Regulatory Submissions, CTMS, Clinical Site Monitoring, Clinical Monitoring, Clinical Research..., SOP
Education
Gonzaga University 1998 — 2002
B.S., Biochemistry
inVentiv Health Clinical April 2015 - Present
inVentiv Health Clinical July 2011 - April 2015
i3 Research April 2010 - July 2011
i3 Research December 2006 - April 2011
Fresenius HemoCare July 2005 - December 2006
Pulmonary Consultants 2003 - July 2005
PC3/AmericasDoctor August 1999 - 2003
Skills
Clinical Trials, ICH-GCP, EDC, Clinical Development, Clinical Research, Training, Microsoft Office, Medical Devices, Sop, Regulatory Submissions, CTMS, Clinical Site Monitoring, Clinical Monitoring, Clinical Research..., SOP
Education
Gonzaga University 1998 — 2002
B.S., Biochemistry
Lindsay Brazzell (Cook)'s i3 Research Experience 2004 - 2005
Job Contract Medical Writer/President of Cook Medical Communications, LLC
Industry Pharmaceuticals
Experience
Cook Med January 2007 - Present
Hoffmann-La Roche 2007 - August 2011
Boehringer Ingelheim Pharmaceuticals 2009 - April 2010
Salix Pharmaceuticals September 2008 - April 2009
Schwarz Biosciences April 2006 - January 2007
Quantum Medical Communications 2005 - 2006
i3Research 2005 - 2006
i3 Pharma Resourcing, a UnitedHealth Group Company 2004 - 2005
i3 Research 2004 - 2005
Novartis Ophthalmics 2003 - 2005
Skills
CRO, Medical Writing, Clinical Research, Clinical Study Design, Regulatory Submissions, Protocol, FDA, Pharmaceutical Industry, Clinical Trials, Clinical Development, GCP, Oncology, Sop, Publication Planning, Infectious Diseases, Clinical Monitoring, Pharmacovigilance, Neurology, Diabetes, Regulatory Affairs, CTMS, Therapeutic Areas, ICH-GCP, Biotechnology, Vaccines, Lifesciences, Life Sciences, SOP
Education
Georgia State University 1990 — 1992
MA, Sociology
Emory University 1986 — 1990
BA, Anthropology
Cook Med January 2007 - Present
Hoffmann-La Roche 2007 - August 2011
Boehringer Ingelheim Pharmaceuticals 2009 - April 2010
Salix Pharmaceuticals September 2008 - April 2009
Schwarz Biosciences April 2006 - January 2007
Quantum Medical Communications 2005 - 2006
i3Research 2005 - 2006
i3 Pharma Resourcing, a UnitedHealth Group Company 2004 - 2005
i3 Research 2004 - 2005
Novartis Ophthalmics 2003 - 2005
Skills
CRO, Medical Writing, Clinical Research, Clinical Study Design, Regulatory Submissions, Protocol, FDA, Pharmaceutical Industry, Clinical Trials, Clinical Development, GCP, Oncology, Sop, Publication Planning, Infectious Diseases, Clinical Monitoring, Pharmacovigilance, Neurology, Diabetes, Regulatory Affairs, CTMS, Therapeutic Areas, ICH-GCP, Biotechnology, Vaccines, Lifesciences, Life Sciences, SOP
Education
Georgia State University 1990 — 1992
MA, Sociology
Emory University 1986 — 1990
BA, Anthropology
Sergey Druganov, MD's i3 Research Experience January 2010 - September 2011
Job Holistic medicine, Homeopathy, Osteopathic Manipulative Treatment
Industry Health, Wellness and Fitness
Experience
Homeopathic Touch LLC July 2015 - Present
D.Popov Homeopathy Center January 2002 - July 2015
i3 Research January 2010 - September 2011
i3 Research May 2008 - January 2010
LegeArtis February 2006 - May 2008
PAREXEL January 2006 - January 2008
PAREXEL Ukraine February 2001 - 2006
Department of clinical immunology and allergology; National Medical University 'O.O. Bogomolec' August 1998 - December 2002
Private Immunorehabilitation Clinic December 2000 - February 2002
Skills
Pharmaceutical, Clinical Trials, Immunology, Treatment, GCP, Clinical Research, ICH-GCP, Clinical, Pediatrics, Healthcare, Homeopathy, Osteopathic..., CRO, CTMS, Hematology, Infectious Diseases, Oncology, Medicine, Clinical Monitoring, Pharmacovigilance, Clinical Development, Pharmaceutics, Therapeutic Areas
Education
The Institute of Classical Osteopathy 2012 — 2013
classical osteopathy
International Academy of Classical Homeopathy (I.A.C.H.) 2010 — 2012
Homeopathic Medicine/Homeopathy
Kyiv Medical University of UAFM 2011 — 2011
Osteopathic Medicine/Osteopathy
D.Popov Homeopathy Center 2001 — 2002
Homeopathic Medicine/Homeopathy
Kyiv National Taras Shevchenko University 1998 — 1999
Manager of Public Health, Public Health Management
Protos Institute of Homeopathy 1997 — 1999
Homeopathic Medicine/Homeopathy
Kiev Medical Academy of Postgraduate Education 1998 — 1998
Specialist, Children Immunology
National Medical University 'O.O. Bogomolec', Kyiv 1991 — 1997
Doctor of Medicine (M.D.), Pediatrics
Homeopathic Touch LLC July 2015 - Present
D.Popov Homeopathy Center January 2002 - July 2015
i3 Research January 2010 - September 2011
i3 Research May 2008 - January 2010
LegeArtis February 2006 - May 2008
PAREXEL January 2006 - January 2008
PAREXEL Ukraine February 2001 - 2006
Department of clinical immunology and allergology; National Medical University 'O.O. Bogomolec' August 1998 - December 2002
Private Immunorehabilitation Clinic December 2000 - February 2002
Skills
Pharmaceutical, Clinical Trials, Immunology, Treatment, GCP, Clinical Research, ICH-GCP, Clinical, Pediatrics, Healthcare, Homeopathy, Osteopathic..., CRO, CTMS, Hematology, Infectious Diseases, Oncology, Medicine, Clinical Monitoring, Pharmacovigilance, Clinical Development, Pharmaceutics, Therapeutic Areas
Education
The Institute of Classical Osteopathy 2012 — 2013
classical osteopathy
International Academy of Classical Homeopathy (I.A.C.H.) 2010 — 2012
Homeopathic Medicine/Homeopathy
Kyiv Medical University of UAFM 2011 — 2011
Osteopathic Medicine/Osteopathy
D.Popov Homeopathy Center 2001 — 2002
Homeopathic Medicine/Homeopathy
Kyiv National Taras Shevchenko University 1998 — 1999
Manager of Public Health, Public Health Management
Protos Institute of Homeopathy 1997 — 1999
Homeopathic Medicine/Homeopathy
Kiev Medical Academy of Postgraduate Education 1998 — 1998
Specialist, Children Immunology
National Medical University 'O.O. Bogomolec', Kyiv 1991 — 1997
Doctor of Medicine (M.D.), Pediatrics
Tiffany Newman, NCCP's i3 Research Experience September 2007 - May 2008
Job Paralegal
Industry Legal Services
Experience
Mecklenburg County Public Defender December 2010 - Present
i3 Research September 2007 - May 2008
RTI International June 2002 - September 2007
Skills
Applicant Tracking..., Technical Recruiting, Employee Relations, Human Resources, Recruiting, Talent Acquisition, Onboarding, College Recruiting, Sourcing, Deferred Compensation, Vendor Management, Organizational..., Talent Management, Employment Law, Executive Search, Training, Contract Management, OFCCP, Process Improvement, Outlook
Education
Central Piedmont Community College 2009 — 2010
Paralegal
North Carolina Agricultural and Technical State University 1998 — 2002
Mecklenburg County Public Defender December 2010 - Present
i3 Research September 2007 - May 2008
RTI International June 2002 - September 2007
Skills
Applicant Tracking..., Technical Recruiting, Employee Relations, Human Resources, Recruiting, Talent Acquisition, Onboarding, College Recruiting, Sourcing, Deferred Compensation, Vendor Management, Organizational..., Talent Management, Employment Law, Executive Search, Training, Contract Management, OFCCP, Process Improvement, Outlook
Education
Central Piedmont Community College 2009 — 2010
Paralegal
North Carolina Agricultural and Technical State University 1998 — 2002
Shirley Zimmerman's i3 Research Experience August 1999 - August 2000
Job CRA ManagerRegional
Industry Research
Experience
PRA Health Sciences May 2010 - Present
Averion International 2009 - 2010
Metropolitan Research Associates August 2007 - September 2009
MDS Pharma Services October 2004 - April 2007
Endpoint Research 2007 - 2007
Kendle International 2001 - 2004
Premier Research 2000 - 2001
i3 Research August 1999 - August 2000
i3 Research August 1997 - August 1999
Skills
CTMS, Clinical Monitoring, CRO, Clinical Research, Clinical Data Management, GCP, Clinical Trials, Vaccines, Pharmaceutical Industry, Clinical Research..., Therapeutic Areas, ICH-GCP, Oncology, EDC, Clinical Development
Education
County College of Morris 1985 — 1988
A.A.S./RN, Nursing
Semmelweis Egyetem 1978 — 1981
medicine
Bethany College 1977 — 1978
PRA Health Sciences May 2010 - Present
Averion International 2009 - 2010
Metropolitan Research Associates August 2007 - September 2009
MDS Pharma Services October 2004 - April 2007
Endpoint Research 2007 - 2007
Kendle International 2001 - 2004
Premier Research 2000 - 2001
i3 Research August 1999 - August 2000
i3 Research August 1997 - August 1999
Skills
CTMS, Clinical Monitoring, CRO, Clinical Research, Clinical Data Management, GCP, Clinical Trials, Vaccines, Pharmaceutical Industry, Clinical Research..., Therapeutic Areas, ICH-GCP, Oncology, EDC, Clinical Development
Education
County College of Morris 1985 — 1988
A.A.S./RN, Nursing
Semmelweis Egyetem 1978 — 1981
medicine
Bethany College 1977 — 1978
Martin Snipes's i3 Research Experience November 2006 - March 2009
Job Independent Research Professional
Industry Pharmaceuticals
Experience
Clinical Research Solutions, LLC June 2011 - Present
Boehringer-Ingelheim March 2010 - Present
Novartis, Lawrence. KS August 2009 - February 2010
i3 Research November 2006 - March 2009
PAREXEL November 2005 - November 2006
PPD, Inc June 2002 - November 2005
Duke University Medical Center February 1998 - June 2002
Skills
Clinical Monitoring, CTMS, Clinical Trials, CRO, GCP, ICH-GCP, Clinical Development, EDC, Oncology, Clinical Research, Pharmaceutical Industry, Biotechnology, Clinical Data Management, Therapeutic Areas, Medical Writing, Sop, FDA, Infectious Diseases, Regulatory Affairs, Regulatory Submissions, Protocol, Diabetes, Oracle Clinical, Gastroenterology, GLP, Drug Safety, Cancer, Lifesciences, Drug Development, Biopharmaceuticals, Patient Recruitment, Medical Devices, Validation, Dermatology, CRF design, IRB, Vaccines, Phase I, Pharmacology, Medidata, Inform, Ophthalmology, Molecular Biology, Hematology, Immunology, Neurology, Biostatistics, Clinical Research..., Clinical Operations, GMP
Education
Fayetteville State University 1990 — 1995
Bachelor of Science (B.S.), Biology, General
Fayetteville State University 1990 — 1995
B.S, Biology
Clinical Research Solutions, LLC June 2011 - Present
Boehringer-Ingelheim March 2010 - Present
Novartis, Lawrence. KS August 2009 - February 2010
i3 Research November 2006 - March 2009
PAREXEL November 2005 - November 2006
PPD, Inc June 2002 - November 2005
Duke University Medical Center February 1998 - June 2002
Skills
Clinical Monitoring, CTMS, Clinical Trials, CRO, GCP, ICH-GCP, Clinical Development, EDC, Oncology, Clinical Research, Pharmaceutical Industry, Biotechnology, Clinical Data Management, Therapeutic Areas, Medical Writing, Sop, FDA, Infectious Diseases, Regulatory Affairs, Regulatory Submissions, Protocol, Diabetes, Oracle Clinical, Gastroenterology, GLP, Drug Safety, Cancer, Lifesciences, Drug Development, Biopharmaceuticals, Patient Recruitment, Medical Devices, Validation, Dermatology, CRF design, IRB, Vaccines, Phase I, Pharmacology, Medidata, Inform, Ophthalmology, Molecular Biology, Hematology, Immunology, Neurology, Biostatistics, Clinical Research..., Clinical Operations, GMP
Education
Fayetteville State University 1990 — 1995
Bachelor of Science (B.S.), Biology, General
Fayetteville State University 1990 — 1995
B.S, Biology
Russ Hudnall's i3 Research Experience December 2010 - October 2011
Job Clinical Study Manager at Indi (Integrated Diagnostics)
Industry Pharmaceuticals
Experience
Indi (Integrated Diagnostics) May 2014 - Present
PRA International September 2013 - May 2014
Quintiles October 2012 - August 2013
Quintiles October 2011 - October 2012
i3 Research December 2010 - October 2011
i3 Research April 2010 - December 2010
PPD June 2006 - September 2009
PPD September 2005 - June 2006
PPD July 2004 - September 2005
PPD June 2002 - July 2004
Skills
Clinical Monitoring, CTMS, CRO, EDC, GCP, ICH-GCP, Clinical Trials, Therapeutic Areas, Clinical Development, Oncology, Clinical Data Management, Infectious Diseases, Regulatory Submissions, Pharmaceutical Industry, Clinical Research, Vaccines, Sop, Pharmacovigilance, Clinical Operations, Oracle Clinical
Education
New York Institute of Technology-Old Westbury 2006 — 2010
Bachelor of Science (BS), Behavioral Science - Sociology
Central Washington University 1995 — 1997
Biology
Indi (Integrated Diagnostics) May 2014 - Present
PRA International September 2013 - May 2014
Quintiles October 2012 - August 2013
Quintiles October 2011 - October 2012
i3 Research December 2010 - October 2011
i3 Research April 2010 - December 2010
PPD June 2006 - September 2009
PPD September 2005 - June 2006
PPD July 2004 - September 2005
PPD June 2002 - July 2004
Skills
Clinical Monitoring, CTMS, CRO, EDC, GCP, ICH-GCP, Clinical Trials, Therapeutic Areas, Clinical Development, Oncology, Clinical Data Management, Infectious Diseases, Regulatory Submissions, Pharmaceutical Industry, Clinical Research, Vaccines, Sop, Pharmacovigilance, Clinical Operations, Oracle Clinical
Education
New York Institute of Technology-Old Westbury 2006 — 2010
Bachelor of Science (BS), Behavioral Science - Sociology
Central Washington University 1995 — 1997
Biology
Aimee McLean Barrera's i3 Research Experience March 2008 - March 2010
Job Senior Project Manager, Global Project Management at inVentiv Health Clinical
Industry Pharmaceuticals
Experience
inVentiv Health Clinical April 2015 - Present
inVentiv Health Clinical May 2012 - Present
PharmaNet/i3 March 2010 - May 2012
i3 Research March 2008 - March 2010
i3 Research September 2006 - March 2008
Skills
CTMS, Clinical Trials, Pharmaceutical Industry, CRO, GCP, Clinical Development, Clinical Monitoring, Clinical Research, Regulatory Affairs, EDC, Clinical Data Management, Sop, FDA, Protocol
Education
Elon University 1990 — 1994
BA, Political Science
inVentiv Health Clinical April 2015 - Present
inVentiv Health Clinical May 2012 - Present
PharmaNet/i3 March 2010 - May 2012
i3 Research March 2008 - March 2010
i3 Research September 2006 - March 2008
Skills
CTMS, Clinical Trials, Pharmaceutical Industry, CRO, GCP, Clinical Development, Clinical Monitoring, Clinical Research, Regulatory Affairs, EDC, Clinical Data Management, Sop, FDA, Protocol
Education
Elon University 1990 — 1994
BA, Political Science
Julie Egner Wilhjelm's i3 Research Experience 2004 - 2005
Job Clinical Operations Lead
Industry Pharmaceuticals
Experience
PAREXEL 2011 - Present
Egner Clinical Trial Consultng, Inc January 2008 - 2010
Wyeth August 2005 - January 2008
i3 Research 2004 - 2005
Skills
CTMS, Clinical Research, CRO, Clinical Monitoring, Clinical Trials, Clinical Development, EDC, ICH-GCP, GCP, GMP
Education
DePauw University 1997 — 2001
BA, Psychology
PAREXEL 2011 - Present
Egner Clinical Trial Consultng, Inc January 2008 - 2010
Wyeth August 2005 - January 2008
i3 Research 2004 - 2005
Skills
CTMS, Clinical Research, CRO, Clinical Monitoring, Clinical Trials, Clinical Development, EDC, ICH-GCP, GCP, GMP
Education
DePauw University 1997 — 2001
BA, Psychology
Christine Cornwell, BS, CCRA's i3 Research Experience April 2008 - December 2008
Job Independent Clinical Research Consultant
Industry Pharmaceuticals
Experience
Consultant June 2015 - Present
PRA Health Sciences December 2014 - June 2015
Genentech December 2008 - November 2014
i3 Research April 2008 - December 2008
Quintiles May 2006 - April 2008
PRA International April 2004 - May 2006
PRA International July 2002 - April 2004
Sepracor February 2002 - June 2002
Averion International May 2001 - April 2002
Skills
Oncology, Clinical Research, EDC, CTMS, ICH-GCP, Ophthalmology, Clinical Operations, Clinical Research..., Clinical Trials, GCP, CRO, Clinical Monitoring, Clinical Development, Pharmaceutical Industry, Therapeutic Areas, SOP, Protocol, FDA, Clinical Data Management
Education
Eastern Connecticut State University 2001 — 2005
Bachelor of Science (BS), Biology, General
Eastern Connecticut State University 2001 — 2005
Bachelor of Science (B.S.), Biology, General
Consultant June 2015 - Present
PRA Health Sciences December 2014 - June 2015
Genentech December 2008 - November 2014
i3 Research April 2008 - December 2008
Quintiles May 2006 - April 2008
PRA International April 2004 - May 2006
PRA International July 2002 - April 2004
Sepracor February 2002 - June 2002
Averion International May 2001 - April 2002
Skills
Oncology, Clinical Research, EDC, CTMS, ICH-GCP, Ophthalmology, Clinical Operations, Clinical Research..., Clinical Trials, GCP, CRO, Clinical Monitoring, Clinical Development, Pharmaceutical Industry, Therapeutic Areas, SOP, Protocol, FDA, Clinical Data Management
Education
Eastern Connecticut State University 2001 — 2005
Bachelor of Science (BS), Biology, General
Eastern Connecticut State University 2001 — 2005
Bachelor of Science (B.S.), Biology, General
Sherwood Barbee's i3 Research Experience June 2004 - January 2007
Job Associate Customer Delivery Manager at Quintiles
Industry Pharmaceuticals
Experience
Quintiles January 2010 - Present
Quintiles January 2007 - January 2010
i3 Research June 2004 - January 2007
Skills
CRO, Clinical Trials, CTMS, GCP, ICH-GCP, EDC, Clinical Monitoring, Clinical Development, Therapeutic Areas, Clinical Data Management, Oncology, Clinical Research, Pharmaceutical Industry, Inform, Clinical Operations, Regulatory Submissions, Regulatory Affairs, Sop
Education
University of North Carolina at Chapel Hill 2012 — 2014
Master of Business Administration (MBA), Strategy and Entrepreneurship
Campbell University 2001 — 2006
MS, Clinical Research
North Carolina Central University 1995 — 1999
BS, Biology, Criminal Justice
Quintiles January 2010 - Present
Quintiles January 2007 - January 2010
i3 Research June 2004 - January 2007
Skills
CRO, Clinical Trials, CTMS, GCP, ICH-GCP, EDC, Clinical Monitoring, Clinical Development, Therapeutic Areas, Clinical Data Management, Oncology, Clinical Research, Pharmaceutical Industry, Inform, Clinical Operations, Regulatory Submissions, Regulatory Affairs, Sop
Education
University of North Carolina at Chapel Hill 2012 — 2014
Master of Business Administration (MBA), Strategy and Entrepreneurship
Campbell University 2001 — 2006
MS, Clinical Research
North Carolina Central University 1995 — 1999
BS, Biology, Criminal Justice
Robin Hernandez's i3 Research Experience 2003 - 2004
Job Outsourcing Professional
Industry Biotechnology
Experience
MedImmune 2011 - 2012
MedImmune 2007 - 2011
MedImmune 2004 - 2007
i3 Research 2003 - 2004
i3 Research 2001 - 2003
Prestwick Clinical, Inc. 2000 - 2001
Quintiles 1999 - 2000
Quintiles 1997 - 1998
Quintiles 1996 - 1997
Skills
Clinical Development, Vendor Management, Clinical Research, Contract Negotiation, Drug Development, Clinical Trials, CRO, Pharmaceutical Industry, Biotechnology, GCP
Education
American University 1992 — 1996
Bachelor's, International Studies, Economics
MedImmune 2011 - 2012
MedImmune 2007 - 2011
MedImmune 2004 - 2007
i3 Research 2003 - 2004
i3 Research 2001 - 2003
Prestwick Clinical, Inc. 2000 - 2001
Quintiles 1999 - 2000
Quintiles 1997 - 1998
Quintiles 1996 - 1997
Skills
Clinical Development, Vendor Management, Clinical Research, Contract Negotiation, Drug Development, Clinical Trials, CRO, Pharmaceutical Industry, Biotechnology, GCP
Education
American University 1992 — 1996
Bachelor's, International Studies, Economics
Rimma Sigal's i3 Research Experience 2005 - 2006
Job Sr. Clinical Research Associate at Abbvie
Industry Pharmaceuticals
Experience
PharmaNet/i3 Sr. Clinical Research AssociateAbbvie2014 - Present
Schering-Plough January 2006 - 2011
Schering-Plough Research Institute January 2006 - 2011
i3 Research 2005 - 2006
PAREXEL 1998 - 2002
Skills
CTMS, Clinical Trials, CRO, Clinical Research, Clinical Research..., Clinical Monitoring, GCP, ICH-GCP, EDC, Clinical Development, Therapeutic Areas, Clinical Data Management, Oncology, Regulatory Submissions, Oracle Clinical
Education
Boston University 1996 — 1998
Master of Public Health (MPH), Public Health/Epidemiology
PharmaNet/i3 Sr. Clinical Research AssociateAbbvie2014 - Present
Schering-Plough January 2006 - 2011
Schering-Plough Research Institute January 2006 - 2011
i3 Research 2005 - 2006
PAREXEL 1998 - 2002
Skills
CTMS, Clinical Trials, CRO, Clinical Research, Clinical Research..., Clinical Monitoring, GCP, ICH-GCP, EDC, Clinical Development, Therapeutic Areas, Clinical Data Management, Oncology, Regulatory Submissions, Oracle Clinical
Education
Boston University 1996 — 1998
Master of Public Health (MPH), Public Health/Epidemiology
Chris Brady, PsyD's i3 Research Experience May 2005 - May 2012
Job Senior Director, RTS at inVentiv Health Clinical
Industry Research
Experience
inVentiv Health Clinical 2005 - Present
i3 Research May 2005 - May 2012
Skills
Clinical Trials, Therapeutic Areas, CRO, Psychiatry, Clinical Development, Neurology, Autism Spectrum..., Research Design, Major Depressive..., Schizophrenia, Bipolar Disorder, Parkinson's, Generalized Anxiety, Pediatric Psychology, ADHD, Drug Development, CTMS, EDC, GCP, Clinical Research, Pharmaceutical Industry, Clinical Monitoring, ICH-GCP, Oncology
Education
Adler School of Professional Psychology 1994 — 2000
Doctor of Psychology, Clinical Psychology
University of Illinois at Urbana-Champaign 1991 — 1994
Bachelor of Arts (BA), Liberal Arts and Sciences, General Studies and Humanities
inVentiv Health Clinical 2005 - Present
i3 Research May 2005 - May 2012
Skills
Clinical Trials, Therapeutic Areas, CRO, Psychiatry, Clinical Development, Neurology, Autism Spectrum..., Research Design, Major Depressive..., Schizophrenia, Bipolar Disorder, Parkinson's, Generalized Anxiety, Pediatric Psychology, ADHD, Drug Development, CTMS, EDC, GCP, Clinical Research, Pharmaceutical Industry, Clinical Monitoring, ICH-GCP, Oncology
Education
Adler School of Professional Psychology 1994 — 2000
Doctor of Psychology, Clinical Psychology
University of Illinois at Urbana-Champaign 1991 — 1994
Bachelor of Arts (BA), Liberal Arts and Sciences, General Studies and Humanities
Lisa Neylan's i3 Research Experience August 2008 - April 2010
Job Clinical Research AssociateIndependent Contractor at Neylan Clinical Research, LLC
Industry Research
Experience
Neylan Clinical Research, LLC November 2014 - Present
PPD November 2013 - October 2014
i3 Research August 2008 - April 2010
i3 Research February 2008 - August 2008
PPD January 2006 - January 2008
PPD August 2005 - January 2006
Dublin City Schools August 2003 - June 2004
Skills
Clinical Monitoring, Training, Clinical Trials, Clinical Research, CTMS, Protocol
Education
The Ohio State University 2002 — 2003
M.Ed, Education
Denison University 1996 — 2000
BA, Biology/Spanish
Neylan Clinical Research, LLC November 2014 - Present
PPD November 2013 - October 2014
i3 Research August 2008 - April 2010
i3 Research February 2008 - August 2008
PPD January 2006 - January 2008
PPD August 2005 - January 2006
Dublin City Schools August 2003 - June 2004
Skills
Clinical Monitoring, Training, Clinical Trials, Clinical Research, CTMS, Protocol
Education
The Ohio State University 2002 — 2003
M.Ed, Education
Denison University 1996 — 2000
BA, Biology/Spanish
Cari Ruzila's i3 Research Experience June 2007 - July 2008
Job InHouse Clinical Research Associate on assignment at Sanofi
Industry Pharmaceuticals
Experience
Sanofi July 2013 - Present
sanofi-aventis December 2010 - July 2013
Pfizer February 2010 - December 2010
Novartis July 2008 - December 2009
i3 Research June 2007 - July 2008
Novartis June 2006 - June 2007
Wyeth October 2004 - May 2006
Skills
Clinical Trials, CTMS, Pharmaceutical Industry, CRO, Therapeutic Areas, Clinical Research, Sop, Clinical Development, Regulatory Affairs, FDA, Clinical Monitoring, Pharmaceutics, Regulatory Submissions, Clinical Data Management, ICH-GCP, Protocol, SOP
Education
Elon University 1991 — 1995
BA, English Literature
Sanofi July 2013 - Present
sanofi-aventis December 2010 - July 2013
Pfizer February 2010 - December 2010
Novartis July 2008 - December 2009
i3 Research June 2007 - July 2008
Novartis June 2006 - June 2007
Wyeth October 2004 - May 2006
Skills
Clinical Trials, CTMS, Pharmaceutical Industry, CRO, Therapeutic Areas, Clinical Research, Sop, Clinical Development, Regulatory Affairs, FDA, Clinical Monitoring, Pharmaceutics, Regulatory Submissions, Clinical Data Management, ICH-GCP, Protocol, SOP
Education
Elon University 1991 — 1995
BA, English Literature
Barry Dillman, RQAP-GCP, CCRP's i3 Research Experience December 2006 - July 2010
Job Owner, Principal Consultant at Good Clinical Consultants Inc.
Industry Pharmaceuticals
Experience
Good Clinical Consultants Inc. January 2013 - Present
inVentiv Health Clinical April 2013 - September 2013
Boston Scientific July 2010 - December 2012
i3 Research December 2006 - July 2010
SCIREX Corporation December 2004 - December 2006
Synarc 2002 - 2004
GlaxoSmithKline May 2002 - December 2002
Skills
FDA, GCP, Clinical Trials, Validation, 21 CFR Part 11, Quality Assurance, EDC, Medical Devices, Computer System..., Clinical Research, SDLC, Visio
Education
Oregon Health and Science University School of Medicine
Doctoral Canidate, Clinical/Medical Laboratory Science/Research and Allied Professions
Drexel University
Doctor of Philosophy (Ph.D.), Clinical/Medical Laboratory Science/Research and Allied Professions
Penn State University 1998 — 2002
Bachelor of Science (B.S.), Biology, Chemistry
Good Clinical Consultants Inc. January 2013 - Present
inVentiv Health Clinical April 2013 - September 2013
Boston Scientific July 2010 - December 2012
i3 Research December 2006 - July 2010
SCIREX Corporation December 2004 - December 2006
Synarc 2002 - 2004
GlaxoSmithKline May 2002 - December 2002
Skills
FDA, GCP, Clinical Trials, Validation, 21 CFR Part 11, Quality Assurance, EDC, Medical Devices, Computer System..., Clinical Research, SDLC, Visio
Education
Oregon Health and Science University School of Medicine
Doctoral Canidate, Clinical/Medical Laboratory Science/Research and Allied Professions
Drexel University
Doctor of Philosophy (Ph.D.), Clinical/Medical Laboratory Science/Research and Allied Professions
Penn State University 1998 — 2002
Bachelor of Science (B.S.), Biology, Chemistry
Amy Rigney's i3 Research Experience April 2006 - May 2007
Job Chief Operations Officer at SPRI Clinical Trials Global
Industry Biotechnology
Experience
SPRI Clinical Trials - Global January 2014 - Present
SPRI Clinical Trials - Global February 2013 - December 2013
SPRI Clinical Trials - Global January 2011 - January 2013
Biolex Therapeutics August 2008 - March 2011
Talecris Biotherapeutics May 2007 - August 2008
i3 Research April 2006 - May 2007
Gilead Sciences December 2001 - March 2006
Triangle Pharmaceuticals August 1999 - December 2001
Skills
Infectious Diseases, CRO, Clinical Trials, CTMS, Biotechnology, GCP, Cross-functional Team..., Clinical Research, Cardiology, Oncology, Gastroenterology, Pharmaceutical Industry, FDA, Clinical Development, Clinical Operations, Medical Devices, EDC
Education
Boston University
M.Ed., Counseling
University of Maryland College Park
B.S., Psychology
SPRI Clinical Trials - Global January 2014 - Present
SPRI Clinical Trials - Global February 2013 - December 2013
SPRI Clinical Trials - Global January 2011 - January 2013
Biolex Therapeutics August 2008 - March 2011
Talecris Biotherapeutics May 2007 - August 2008
i3 Research April 2006 - May 2007
Gilead Sciences December 2001 - March 2006
Triangle Pharmaceuticals August 1999 - December 2001
Skills
Infectious Diseases, CRO, Clinical Trials, CTMS, Biotechnology, GCP, Cross-functional Team..., Clinical Research, Cardiology, Oncology, Gastroenterology, Pharmaceutical Industry, FDA, Clinical Development, Clinical Operations, Medical Devices, EDC
Education
Boston University
M.Ed., Counseling
University of Maryland College Park
B.S., Psychology
Laura Olson, CCRA's i3 Research Experience November 2006 - May 2008
Job Clinical Research Specialist, AMS
Industry Research
Experience
American Medical Systems August 2013 - Present
American Medical Systems April 2012 - August 2013
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) June 2011 - April 2012
RCRI, Inc. December 2010 - June 2011
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) June 2008 - December 2010
i3 Research November 2006 - May 2008
Medtronic October 2004 - November 2006
Minneapolis Clinic of Neurology March 2003 - October 2004
Skills
Clinical Trials, GCP
Education
Concordia University-St. Paul 2010 — 2011
B.A., Organizational Management & Leadership
Dunwoody College of Technology
American Medical Systems August 2013 - Present
American Medical Systems April 2012 - August 2013
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) June 2011 - April 2012
RCRI, Inc. December 2010 - June 2011
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) June 2008 - December 2010
i3 Research November 2006 - May 2008
Medtronic October 2004 - November 2006
Minneapolis Clinic of Neurology March 2003 - October 2004
Skills
Clinical Trials, GCP
Education
Concordia University-St. Paul 2010 — 2011
B.A., Organizational Management & Leadership
Dunwoody College of Technology
Jeffrey Kempker's i3 Research Experience 2006 - 2008
Job Senior CRA at inVentiv Health
Industry Pharmaceuticals
Experience
inVentiv Health April 2013 - Present
INC Research July 2012 - March 2013
Kforce Clinical Research, Inc. August 2008 - June 2012
PharmaNet/i3 Strategic Resourcing August 2008 - June 2012
i3 Research 2006 - 2008
Quintiles 2004 - 2006
Eli Lilly 2004 - 2004
Skills
Clinical Monitoring, GCP, Clinical Research, EDC, Clinical Trial..., Endocrinology, Neurology, Diabetes, Phase I, Cardiology, Pediatrics, Allergy, Data Entry, CTMS, Inform, Asthma, Psychiatry, Hypertension, COPD, Rheumatology, Excel, Therapeutic areas, Data Management, Quality Assurance, CRO, Clinical Data Management, Therapeutic Areas
Education
Indiana University Bloomington 1992 — 1998
Master's Public Health, Public Health
inVentiv Health April 2013 - Present
INC Research July 2012 - March 2013
Kforce Clinical Research, Inc. August 2008 - June 2012
PharmaNet/i3 Strategic Resourcing August 2008 - June 2012
i3 Research 2006 - 2008
Quintiles 2004 - 2006
Eli Lilly 2004 - 2004
Skills
Clinical Monitoring, GCP, Clinical Research, EDC, Clinical Trial..., Endocrinology, Neurology, Diabetes, Phase I, Cardiology, Pediatrics, Allergy, Data Entry, CTMS, Inform, Asthma, Psychiatry, Hypertension, COPD, Rheumatology, Excel, Therapeutic areas, Data Management, Quality Assurance, CRO, Clinical Data Management, Therapeutic Areas
Education
Indiana University Bloomington 1992 — 1998
Master's Public Health, Public Health
Amy Robey's i3 Research Experience 2010 - 2011
Job Experienced Clinical Operations Manager , Vaccines/Pharmaceutical Industry
Industry Pharmaceuticals
Experience
i3 Research 2010 - 2011
GlaxoSmithKline Biologicals 2008 - 2010
Kforce Inc. 2005 - 2006
GSK 1998 - 2004
Skills
CTMS, Clinical Trials, GCP, CRO, Clinical Monitoring, Clinical Development, ICH-GCP, EDC, Oncology, Pharmaceutical Industry, Therapeutic Areas, Clinical Data Management, Clinical Research, Sop, Infectious Diseases, Vaccines, Protocol, Clinical Operations, Drug Development, Pharmacovigilance, Regulatory Submissions
Education
Towson University 1992 — 1995
BSN
Goucher College 1989 — 1992
BA
i3 Research 2010 - 2011
GlaxoSmithKline Biologicals 2008 - 2010
Kforce Inc. 2005 - 2006
GSK 1998 - 2004
Skills
CTMS, Clinical Trials, GCP, CRO, Clinical Monitoring, Clinical Development, ICH-GCP, EDC, Oncology, Pharmaceutical Industry, Therapeutic Areas, Clinical Data Management, Clinical Research, Sop, Infectious Diseases, Vaccines, Protocol, Clinical Operations, Drug Development, Pharmacovigilance, Regulatory Submissions
Education
Towson University 1992 — 1995
BSN
Goucher College 1989 — 1992
BA
Millie Shultz's i3 Research Experience 2003 - 2004
Job Director, Oncology Indication Lead
Industry Pharmaceuticals
Experience
Merck August 2015 - Present
Cubist Pharmaceuticals February 2014 - July 2015
Millennium Pharmaceuticals March 2012 - February 2014
Takeda Shanghai Development Center July 2012 - April 2013
Millennium Pharmaceuticals December 2009 - March 2012
Millennium Pharmaceuticals 2005 - January 2010
BattelleCRO 2004 - 2005
i3 Research 2003 - 2004
Quintiles 2002 - 2003
Schering Plough 2002 - 2002
Skills
Clinical Development, Pharmaceutical Industry, Oncology, Clinical Trials, Clinical Operations, Clinical Research, CRO, CTMS, Drug Development, Biotechnology, EDC, GCP, ICH-GCP, Regulatory Submissions, Therapeutic Areas
Education
Harvard University 2006 — 2010
Cancer Biology, Pharmacology, Anatomy & Physiology
The George Washington University School of Medicine and Health Sciences 2003 — 2005
MSHS, Clinical Research Administration
Purdue University 1993 — 1997
BS, Environmental Science and Natural Resources
Merck August 2015 - Present
Cubist Pharmaceuticals February 2014 - July 2015
Millennium Pharmaceuticals March 2012 - February 2014
Takeda Shanghai Development Center July 2012 - April 2013
Millennium Pharmaceuticals December 2009 - March 2012
Millennium Pharmaceuticals 2005 - January 2010
BattelleCRO 2004 - 2005
i3 Research 2003 - 2004
Quintiles 2002 - 2003
Schering Plough 2002 - 2002
Skills
Clinical Development, Pharmaceutical Industry, Oncology, Clinical Trials, Clinical Operations, Clinical Research, CRO, CTMS, Drug Development, Biotechnology, EDC, GCP, ICH-GCP, Regulatory Submissions, Therapeutic Areas
Education
Harvard University 2006 — 2010
Cancer Biology, Pharmacology, Anatomy & Physiology
The George Washington University School of Medicine and Health Sciences 2003 — 2005
MSHS, Clinical Research Administration
Purdue University 1993 — 1997
BS, Environmental Science and Natural Resources
Stephanie D. Sutton-Sheehan, MBA's i3 Research Experience December 2006 - April 2008
Job Senior Clinical Research Associate at TFS Trial Form Support
Industry Pharmaceuticals
Experience
TFS Trial Form Support January 2015 - Present
PRA Health Sciences August 2013 - January 2015
ReSearch Pharmaceutical Services August 2012 - July 2013
ClinForce April 2012 - August 2012
Sarah Cannon Research Institute December 2009 - January 2011
Clinical Research Consultant 2007 - 2009
i3 Research December 2006 - April 2008
PPD May 2006 - April 2008
Digital Image Marketing, LLC January 2005 - April 2008
Hospira Inc February 2004 - November 2004
Skills
Clinical Research, Therapeutic Areas, CTMS, Clinical Trials, GCP, EDC, Clinical Trial..., ICH-GCP, Project Management, Clinical Site Management, Patient Recruitment, Site Investigation, Quality Management, Clinical Site Monitoring, FDA GMP, Project Planning, Project Implementation, Project Finance, Process Management, Process Improvement, Business Process Mapping, Small Business..., Marketing Management, Social Media Marketing, Marketing Research, Medical Research, Legal Research Skills, Biostatistics, Biotechnology Industry, Oncology, Monoclonal Antibodies, Biopharmaceuticals, Clinical Cardiology, Type 2 Diabetes, COPD, Asthma, Angioedema, Immunology, Neurology, Tobacco Cessation, Microsoft Office, Microsoft Technologies, Microsoft Project, Adobe Professional, Adobe LiveCycle Designer, Adobe Creative Suite, eTMF, Digital Printing, Crystal Reports, Pharmaceutical Industry
Education
Bellevue College 2013 — 2013
N/A, Arabic Language and Literature, Pass
American InterContinental University 2004 — 2005
MBA, International Marketing, 3.98
University of Washington, Michael G. Foster School of Business 2000 — 2000
Certificate-Executive Program, Business Administration and Management, General, Pass
University of Washington 1996 — 2000
BA, Medicine
University of Washington School of Medicine 1995 — 1995
Certificate, Minority Medical Education Program, Pass
Highline College 1992 — 1995
Associate of Arts (A.A.), Psychology
TFS Trial Form Support January 2015 - Present
PRA Health Sciences August 2013 - January 2015
ReSearch Pharmaceutical Services August 2012 - July 2013
ClinForce April 2012 - August 2012
Sarah Cannon Research Institute December 2009 - January 2011
Clinical Research Consultant 2007 - 2009
i3 Research December 2006 - April 2008
PPD May 2006 - April 2008
Digital Image Marketing, LLC January 2005 - April 2008
Hospira Inc February 2004 - November 2004
Skills
Clinical Research, Therapeutic Areas, CTMS, Clinical Trials, GCP, EDC, Clinical Trial..., ICH-GCP, Project Management, Clinical Site Management, Patient Recruitment, Site Investigation, Quality Management, Clinical Site Monitoring, FDA GMP, Project Planning, Project Implementation, Project Finance, Process Management, Process Improvement, Business Process Mapping, Small Business..., Marketing Management, Social Media Marketing, Marketing Research, Medical Research, Legal Research Skills, Biostatistics, Biotechnology Industry, Oncology, Monoclonal Antibodies, Biopharmaceuticals, Clinical Cardiology, Type 2 Diabetes, COPD, Asthma, Angioedema, Immunology, Neurology, Tobacco Cessation, Microsoft Office, Microsoft Technologies, Microsoft Project, Adobe Professional, Adobe LiveCycle Designer, Adobe Creative Suite, eTMF, Digital Printing, Crystal Reports, Pharmaceutical Industry
Education
Bellevue College 2013 — 2013
N/A, Arabic Language and Literature, Pass
American InterContinental University 2004 — 2005
MBA, International Marketing, 3.98
University of Washington, Michael G. Foster School of Business 2000 — 2000
Certificate-Executive Program, Business Administration and Management, General, Pass
University of Washington 1996 — 2000
BA, Medicine
University of Washington School of Medicine 1995 — 1995
Certificate, Minority Medical Education Program, Pass
Highline College 1992 — 1995
Associate of Arts (A.A.), Psychology
Tim Crowder's i3 Research Experience March 2000 - November 2005
Job Contract Clinical Research Associate at Crowder Clinical Consulting, LLC
Industry Biotechnology
Experience
Crowder Clinical Consulting, LLC January 2012 - Present
Amgen/Quintiles November 2005 - December 2011
i3 Research March 2000 - November 2005
CTMS June 1997 - March 2000
Baxter Healthcare August 1994 - June 1997
Skills
Clinical Research, Microbiology, CTMS, GCP, Clinical Monitoring, Clinical Trials, Oncology, EDC, Clinical Development, CRO, Therapeutic Areas, ICH-GCP, Clinical Data Management, Clinical Operations, Infectious Diseases
Education
East Tennessee State University 2008 — 2013
Doctoral Candidate, Epidemiology
The George Washington University School of Medicine and Health Sciences 2002 — 2005
MSHS, Health Science
East Tennessee State University 1991 — 1996
BS, Major Microbiology Minor Biology
Crowder Clinical Consulting, LLC January 2012 - Present
Amgen/Quintiles November 2005 - December 2011
i3 Research March 2000 - November 2005
CTMS June 1997 - March 2000
Baxter Healthcare August 1994 - June 1997
Skills
Clinical Research, Microbiology, CTMS, GCP, Clinical Monitoring, Clinical Trials, Oncology, EDC, Clinical Development, CRO, Therapeutic Areas, ICH-GCP, Clinical Data Management, Clinical Operations, Infectious Diseases
Education
East Tennessee State University 2008 — 2013
Doctoral Candidate, Epidemiology
The George Washington University School of Medicine and Health Sciences 2002 — 2005
MSHS, Health Science
East Tennessee State University 1991 — 1996
BS, Major Microbiology Minor Biology
Kevin Ketchum's i3 Research Experience October 2009 - January 2011
Job Project Leader II at Duke Clinical Research Institute
Industry Pharmaceuticals
Experience
Duke Clinical Research Institute September 2014 - Present
INC Research June 2012 - September 2014
PharmaNet/i3 July 2011 - June 2012
Health Decisions January 2011 - July 2011
i3 Research October 2009 - January 2011
Novella Clinical September 2008 - August 2009
inc research August 2007 - September 2008
Quintiles June 2003 - August 2007
Duke University Medical Center 2000 - 2003
Skills
Regulatory Submissions, Clinical Monitoring, CRO, Leadership, ICH-GCP, Clinical Trials, Sop, Clinical Data Management, CTMS, Clinical Development, Clinical Study Design, EDC, GCP, Therapeutic Areas, Clinical Research, Pharmaceutical Industry, Oncology
Education
East Stroudsburg University of Pennsylvania 1998 — 1999
MS, Cardiac Rehabilitation & Exercise Science
East Stroudsburg University of Pennsylvania 1995 — 1997
BS, Exercise Physiology
Millersville University of Pennsylvania 1995 — 1996
Millersville University of Pennsylvania 1987 — 1989
Duke Clinical Research Institute September 2014 - Present
INC Research June 2012 - September 2014
PharmaNet/i3 July 2011 - June 2012
Health Decisions January 2011 - July 2011
i3 Research October 2009 - January 2011
Novella Clinical September 2008 - August 2009
inc research August 2007 - September 2008
Quintiles June 2003 - August 2007
Duke University Medical Center 2000 - 2003
Skills
Regulatory Submissions, Clinical Monitoring, CRO, Leadership, ICH-GCP, Clinical Trials, Sop, Clinical Data Management, CTMS, Clinical Development, Clinical Study Design, EDC, GCP, Therapeutic Areas, Clinical Research, Pharmaceutical Industry, Oncology
Education
East Stroudsburg University of Pennsylvania 1998 — 1999
MS, Cardiac Rehabilitation & Exercise Science
East Stroudsburg University of Pennsylvania 1995 — 1997
BS, Exercise Physiology
Millersville University of Pennsylvania 1995 — 1996
Millersville University of Pennsylvania 1987 — 1989
Jennifer Croan's i3 Research Experience June 2007 - May 2009
Job Senior Proposal Associate, Business Development Operations at Worldwide Clinical Trials, Inc.
Industry Pharmaceuticals
Experience
Worldwide Clinical Trials April 2015 - Present
Worldwide Clinical Trials, Inc. August 2011 - March 2015
Covance Laboratories Inc May 2009 - February 2011
i3 Research June 2007 - May 2009
Eli Lilly and Company April 2005 - June 2007
Eli Lilly & Company, Lilly Research Laboratories July 1995 - April 2005
Skills
Contract Negotiation, CRO, Pharmaceutical Industry, Business Development, Process Improvement, Program Management, Project Management, Proposal Writing, Life Sciences
Education
Indiana Wesleyan University 2001 — 2003
Bachelor
Purdue University 1994 — 1995
Associate
Worldwide Clinical Trials April 2015 - Present
Worldwide Clinical Trials, Inc. August 2011 - March 2015
Covance Laboratories Inc May 2009 - February 2011
i3 Research June 2007 - May 2009
Eli Lilly and Company April 2005 - June 2007
Eli Lilly & Company, Lilly Research Laboratories July 1995 - April 2005
Skills
Contract Negotiation, CRO, Pharmaceutical Industry, Business Development, Process Improvement, Program Management, Project Management, Proposal Writing, Life Sciences
Education
Indiana Wesleyan University 2001 — 2003
Bachelor
Purdue University 1994 — 1995
Associate
Katharina Uffelman's i3 Research Experience March 2005 - October 2006
Job Vice President Global Operations at Quintiles
Industry Pharmaceuticals
Experience
Quintiles July 2012 - Present
OptumInsight October 2010 - July 2012
i3 Global August 2009 - October 2010
i3 global 2006 - August 2009
i3 Research March 2005 - October 2006
i3 Research January 2004 - March 2005
Inveresk March 2002 - January 2004
PharmaResearch 2001 - 2004
Skills
Clinical Trials, Clinical Development, CRO, GCP, CTMS, EDC, Drug Development, ICH-GCP
Education
Averett University
MBA
Averett University
BS
Quintiles July 2012 - Present
OptumInsight October 2010 - July 2012
i3 Global August 2009 - October 2010
i3 global 2006 - August 2009
i3 Research March 2005 - October 2006
i3 Research January 2004 - March 2005
Inveresk March 2002 - January 2004
PharmaResearch 2001 - 2004
Skills
Clinical Trials, Clinical Development, CRO, GCP, CTMS, EDC, Drug Development, ICH-GCP
Education
Averett University
MBA
Averett University
BS
Deborah Nicholas's i3 Research Experience December 2008 - June 2009
Job Statistician
Industry Banking
Experience
Target Corporation September 2014 - September 2015
Contract/Temporary Positions June 2010 - May 2013
WCPE Radio December 1996 - October 2012
i3 Research December 2008 - June 2009
The Carolinas Center for Medical Excellence November 2006 - October 2008
The Carolinas Center for Medical Excellence January 2000 - November 2006
Additional Experience May 1980 - November 2000
Skills
SAS, Analytics, Statistics, SAS programming, Data Analysis, Leadership, Data Management, Microsoft Office, Editing, Access, Excel, SAS/SQL, PowerPoint, Word, Proofreading, Relational Databases, Microsoft Excel, Microsoft Word, SAS Programming, Analysis, Research
Education
Duke University
Bachelor of Science (B.S.), Psychology
North Carolina State University
Bachelor of Science (B.S.), Statistics (minor in Economics)
North Carolina State University
Master of Science (M.S.), Advanced Analytics
Target Corporation September 2014 - September 2015
Contract/Temporary Positions June 2010 - May 2013
WCPE Radio December 1996 - October 2012
i3 Research December 2008 - June 2009
The Carolinas Center for Medical Excellence November 2006 - October 2008
The Carolinas Center for Medical Excellence January 2000 - November 2006
Additional Experience May 1980 - November 2000
Skills
SAS, Analytics, Statistics, SAS programming, Data Analysis, Leadership, Data Management, Microsoft Office, Editing, Access, Excel, SAS/SQL, PowerPoint, Word, Proofreading, Relational Databases, Microsoft Excel, Microsoft Word, SAS Programming, Analysis, Research
Education
Duke University
Bachelor of Science (B.S.), Psychology
North Carolina State University
Bachelor of Science (B.S.), Statistics (minor in Economics)
North Carolina State University
Master of Science (M.S.), Advanced Analytics
Virginia (Ginger) Haynes's i3 Research Experience September 2007 - June 2011
Job Principal Research Scientist, Global Health Outcomes, Eli Lilly
Industry Pharmaceuticals
Experience
Eli Lilly and Company June 2011 - Present
i3 Research September 2007 - June 2011
Eli Lilly 1998 - 2007
Lilly 1998 - 2007
Eli Lilly & Co / Zyprexa Product Team 1998 - 2001
Skills
Statistics, Clinical Trials, SAS, Pharmaceutical Industry, Medicine, Biostatistics, Clinical Research, EDC, GCP, Neuroscience, Research, Clinical Study Design, Leadership, CTMS, Medical Devices, Drug Development, CRO, Biotechnology, Clinical Development, Oncology, Lifesciences, Life Sciences
Education
Baylor University 1995 — 1998
PhD, Statistics
Eli Lilly and Company June 2011 - Present
i3 Research September 2007 - June 2011
Eli Lilly 1998 - 2007
Lilly 1998 - 2007
Eli Lilly & Co / Zyprexa Product Team 1998 - 2001
Skills
Statistics, Clinical Trials, SAS, Pharmaceutical Industry, Medicine, Biostatistics, Clinical Research, EDC, GCP, Neuroscience, Research, Clinical Study Design, Leadership, CTMS, Medical Devices, Drug Development, CRO, Biotechnology, Clinical Development, Oncology, Lifesciences, Life Sciences
Education
Baylor University 1995 — 1998
PhD, Statistics
AnhDao Vu's i3 Research Experience 2005 - 2006
Job Clinical Research Professional
Industry Pharmaceuticals
Experience
Company Confidential 2008 - Present
INC Research 2007 - 2008
Company Confidential 2006 - 2007
i3 Research 2005 - 2006
i3 Statprobe 2004 - 2005
John Wayne Cancer Institute 2003 - 2004
Beckman Coulter 2002 - 2004
Ribapharm Inc. 2002 - 2003
Horizon Medical 2000 - 2002
Watson Pharmaceuticals 1999 - 2000
Education
California State University-Dominguez Hills
Master of Science (MS), Quality Assurance
California State University-Fullerton
Bachelor of Science (BS), Biochemistry
Company Confidential 2008 - Present
INC Research 2007 - 2008
Company Confidential 2006 - 2007
i3 Research 2005 - 2006
i3 Statprobe 2004 - 2005
John Wayne Cancer Institute 2003 - 2004
Beckman Coulter 2002 - 2004
Ribapharm Inc. 2002 - 2003
Horizon Medical 2000 - 2002
Watson Pharmaceuticals 1999 - 2000
Education
California State University-Dominguez Hills
Master of Science (MS), Quality Assurance
California State University-Fullerton
Bachelor of Science (BS), Biochemistry
Michele Visser's i3 Research Experience May 2006 - June 2011
Job Business Development Inside Sales at ICON plc
Industry Biotechnology
Experience
ICON plc July 2015 - Present
Theorem Clinical Research October 2014 - June 2015
inVentiv Health Clinical June 2011 - October 2014
i3 Research May 2006 - June 2011
Allphase Clinical Research September 2005 - May 2006
PRA International October 2000 - August 2005
University of Ottawa Heart Institute 1998 - 2000
Skills
Lifesciences, Clinical Trials, Pharmaceutical Industry, EDC, CRO, Neurology, Oncology, Business Development, Biotechnology, Clinical Monitoring, CRM, Marketing, GCP, Medical Devices, Start-ups, CTMS, Global Business..., Drug Development, Clinical Data Management, Infectious Diseases, Cross-functional Team..., Regulatory Affairs, Clinical Research, Clinical Development, Protocol, Therapeutic Areas, Life Sciences, Biopharmaceuticals
Education
Carleton University 1996 — 1999
BPA - Honours, Public Administration
ICON plc July 2015 - Present
Theorem Clinical Research October 2014 - June 2015
inVentiv Health Clinical June 2011 - October 2014
i3 Research May 2006 - June 2011
Allphase Clinical Research September 2005 - May 2006
PRA International October 2000 - August 2005
University of Ottawa Heart Institute 1998 - 2000
Skills
Lifesciences, Clinical Trials, Pharmaceutical Industry, EDC, CRO, Neurology, Oncology, Business Development, Biotechnology, Clinical Monitoring, CRM, Marketing, GCP, Medical Devices, Start-ups, CTMS, Global Business..., Drug Development, Clinical Data Management, Infectious Diseases, Cross-functional Team..., Regulatory Affairs, Clinical Research, Clinical Development, Protocol, Therapeutic Areas, Life Sciences, Biopharmaceuticals
Education
Carleton University 1996 — 1999
BPA - Honours, Public Administration
Brenda Abell's i3 Research Experience October 2010 - Present
Job CTA/Document Review at i3 Research
Industry Pharmaceuticals
Experience
i3 Research October 2010 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2008 - August 2010
GE Healthcare 1998 - 2008
Education
Temple University 2003 — 2007
MS, Quality Assurance/Regulatory Affairs
Rider University 1999 — 2002
BA, Liberal Arts - with a concentration in business
Corning Community College 1994 — 1996
A.S., Liberal Arts
i3 Research October 2010 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2008 - August 2010
GE Healthcare 1998 - 2008
Education
Temple University 2003 — 2007
MS, Quality Assurance/Regulatory Affairs
Rider University 1999 — 2002
BA, Liberal Arts - with a concentration in business
Corning Community College 1994 — 1996
A.S., Liberal Arts
Pamela Buchholz's i3 Research Experience April 2009 - May 2010
Job Senior Director Clinical Trials Domain at Duke Clinical Research Institute
Industry Hospital & Health Care
Experience
Duke Clinical Research Institute July 2015 - Present
Duke Clinical Research Institute December 2014 - July 2015
Duke Clinical Research Institute May 2011 - December 2014
i3 Research April 2009 - May 2010
Spacelabs Healthcare January 2007 - January 2009
Hertford Cardiology (formerly Quantum Research) March 2005 - January 2007
Quantum Research July 2003 - March 2005
Harley Street Cardiovascular Investigations June 1999 - July 2003
The Ayr Hospital April 1993 - May 1999
Skills
Cardiology, Clinical Trials, Clinical Research, Medical Devices, GCP, FDA, Oncology, Biotechnology, Clinical Development, CRO, Clinical Data Management, EDC, Regulatory Affairs, Protocol, Lifesciences, Sop, Medical Writing, CTMS, Life Sciences, SOP
Education
Glasgow Caledonian University
Stowe College, Glasgow
Duke Clinical Research Institute July 2015 - Present
Duke Clinical Research Institute December 2014 - July 2015
Duke Clinical Research Institute May 2011 - December 2014
i3 Research April 2009 - May 2010
Spacelabs Healthcare January 2007 - January 2009
Hertford Cardiology (formerly Quantum Research) March 2005 - January 2007
Quantum Research July 2003 - March 2005
Harley Street Cardiovascular Investigations June 1999 - July 2003
The Ayr Hospital April 1993 - May 1999
Skills
Cardiology, Clinical Trials, Clinical Research, Medical Devices, GCP, FDA, Oncology, Biotechnology, Clinical Development, CRO, Clinical Data Management, EDC, Regulatory Affairs, Protocol, Lifesciences, Sop, Medical Writing, CTMS, Life Sciences, SOP
Education
Glasgow Caledonian University
Stowe College, Glasgow
Lydia Kohls's i3 Research Experience 1999 - 2008
Job Project Manager at InventivHealth
Industry Research
Experience
PharmaNet/i3 October 2011 - Present
AGA Medical June 2010 - October 2011
AGA Medical June 2009 - June 2010
i3 Research 1999 - 2008
i3 Research 1999 - 2005
Education
Antioch University New England 1990 — 1992
MES, Resource Management and Adminstration
Hampshire College 1980 — 1985
BA, Environmental Studies
PharmaNet/i3 October 2011 - Present
AGA Medical June 2010 - October 2011
AGA Medical June 2009 - June 2010
i3 Research 1999 - 2008
i3 Research 1999 - 2005
Education
Antioch University New England 1990 — 1992
MES, Resource Management and Adminstration
Hampshire College 1980 — 1985
BA, Environmental Studies
Gerry Montgomery's i3 Research Experience May 2009 - July 2011
Job Director Business Development at etera solutions
Industry Management Consulting
Experience
etera solutions December 2013 - Present
RNsights September 2012 - December 2013
RelayHealth July 2011 - September 2012
i3 Research May 2009 - July 2011
The Zitter Group June 2007 - February 2009
Neuro Metrix June 2006 - June 2007
Alcon 1991 - 1998
Skills
Pharmaceutical Industry, Medical Devices
Education
Drexel University - LeBow College of Business 1982 — 1986
BS, Business Administration
etera solutions December 2013 - Present
RNsights September 2012 - December 2013
RelayHealth July 2011 - September 2012
i3 Research May 2009 - July 2011
The Zitter Group June 2007 - February 2009
Neuro Metrix June 2006 - June 2007
Alcon 1991 - 1998
Skills
Pharmaceutical Industry, Medical Devices
Education
Drexel University - LeBow College of Business 1982 — 1986
BS, Business Administration
Alyson O'Donnell's i3 Research Experience February 2008 - April 2009
Job Sr, Director, ICON Commercialisation & Outcomes at ICON plc
Industry Pharmaceuticals
Experience
ICON plc March 2015 - Present
Clinipace Worldwide July 2014 - March 2015
DOCS, a division of ICON plc September 2011 - June 2014
United BioSource Corporation June 2010 - August 2011
Medpace April 2009 - April 2010
i3 Research February 2008 - April 2009
i3 Research February 2006 - February 2008
Publicis Selling Solutions March 2005 - February 2006
Covance May 2004 - March 2005
Covance September 2001 - May 2004
Skills
Pharmaceutical Industry, CRO, Clinical Development, Clinical Trials, CTMS, Biotechnology, GCP, Oncology, Regulatory Affairs, EDC
Education
City University London 1995 — 1997
MBA, International Business
ICON plc March 2015 - Present
Clinipace Worldwide July 2014 - March 2015
DOCS, a division of ICON plc September 2011 - June 2014
United BioSource Corporation June 2010 - August 2011
Medpace April 2009 - April 2010
i3 Research February 2008 - April 2009
i3 Research February 2006 - February 2008
Publicis Selling Solutions March 2005 - February 2006
Covance May 2004 - March 2005
Covance September 2001 - May 2004
Skills
Pharmaceutical Industry, CRO, Clinical Development, Clinical Trials, CTMS, Biotechnology, GCP, Oncology, Regulatory Affairs, EDC
Education
City University London 1995 — 1997
MBA, International Business
Heidi Marks's i3 Research Experience 1999 - 2007
Job President, Marks Consulting, LLC
Industry Pharmaceuticals
Experience
Marks Consulting, LLC June 2007 - Present
eReady Monitors 1997 - May 2010
Trio Clinical Research 2007 - 2009
i3 research 1999 - 2007
On the Mark 1997 - 1998
Celgene 1996 - 1998
Eisai N. A. Pharmaceuticals 1995 - 1996
American Cyanamid Lederle Labs 1993 - 1995
Education
University of North Carolina at Chapel Hill 2010 — 2010
certificate, Paralegal
Brandeis University 1984 — 1987
spring valley high school 1981 — 1984
Marks Consulting, LLC June 2007 - Present
eReady Monitors 1997 - May 2010
Trio Clinical Research 2007 - 2009
i3 research 1999 - 2007
On the Mark 1997 - 1998
Celgene 1996 - 1998
Eisai N. A. Pharmaceuticals 1995 - 1996
American Cyanamid Lederle Labs 1993 - 1995
Education
University of North Carolina at Chapel Hill 2010 — 2010
certificate, Paralegal
Brandeis University 1984 — 1987
spring valley high school 1981 — 1984
Andrea Rochlitz's i3 Research Experience January 2007 - November 2008
Job at CRAMed Bt
Industry Pharmaceuticals
Experience
CRA-Med Bt February 2007 - Present
i3 Research January 2007 - November 2008
PPD Hungary January 2005 - January 2007
PRA International, Budapest September 2003 - January 2005
PRA International, Budapest May 2003 - September 2003
Skills
Clinical Research, CTMS, Regulatory Submissions, ICH-GCP, Clinical Monitoring, CRO, Clinical Trials, GCP, Therapeutic Areas, Gastroenterology, EDC, Clinical Operations, Protocol, Clinical Data Management, Clinical Research..., Clinical Development
Education
Eötvös Loránd University 1998 — 2000
BA, English
'Bárczi Gusztáv' Teacher's Training College of Special Education 1987 — 1990
BSc, Special Education
CRA-Med Bt February 2007 - Present
i3 Research January 2007 - November 2008
PPD Hungary January 2005 - January 2007
PRA International, Budapest September 2003 - January 2005
PRA International, Budapest May 2003 - September 2003
Skills
Clinical Research, CTMS, Regulatory Submissions, ICH-GCP, Clinical Monitoring, CRO, Clinical Trials, GCP, Therapeutic Areas, Gastroenterology, EDC, Clinical Operations, Protocol, Clinical Data Management, Clinical Research..., Clinical Development
Education
Eötvös Loránd University 1998 — 2000
BA, English
'Bárczi Gusztáv' Teacher's Training College of Special Education 1987 — 1990
BSc, Special Education
Nathan Buerstatte's i3 Research Experience December 2011 - January 2013
Job Clinical Trial Manager at FORUM Pharmaceuticals (previously EnVivo Pharmaceuticals)
Industry Research
Experience
FORUM Pharmaceuticals (previously EnVivo Pharmaceuticals) November 2013 - Present
Biogen Idec April 2013 - October 2013
Biogen Idec January 2013 - April 2013
i3 Research December 2011 - January 2013
New England Research Institutes, Inc. (NERI) August 2008 - September 2011
Skills
Clinical Trials, Biotechnology, Lifesciences, Biostatistics, Statistics, CRO, Qualitative Research, Epidemiology, Research Design, Survey Research, SAS, GCP, Data Analysis, Public Health, CTMS, Vendor Management, Leading Meetings, Team Management, Timelines, Deliverables, Project Oversight, Phase 1, Phase 2, Protocol Design, Clinical Operations
Education
Boston University School of Public Health 2000 — 2002
MPH, Epidemiology
Boston College 1996 — 2000
BS, Biology, General
FORUM Pharmaceuticals (previously EnVivo Pharmaceuticals) November 2013 - Present
Biogen Idec April 2013 - October 2013
Biogen Idec January 2013 - April 2013
i3 Research December 2011 - January 2013
New England Research Institutes, Inc. (NERI) August 2008 - September 2011
Skills
Clinical Trials, Biotechnology, Lifesciences, Biostatistics, Statistics, CRO, Qualitative Research, Epidemiology, Research Design, Survey Research, SAS, GCP, Data Analysis, Public Health, CTMS, Vendor Management, Leading Meetings, Team Management, Timelines, Deliverables, Project Oversight, Phase 1, Phase 2, Protocol Design, Clinical Operations
Education
Boston University School of Public Health 2000 — 2002
MPH, Epidemiology
Boston College 1996 — 2000
BS, Biology, General
Pupul Ashta's i3 Research Experience January 2008 - January 2010
Job Clinical Research Associate III at INC Research
Industry Pharmaceuticals
Experience
INC Research 2013 - Present
INC Research December 2010 - October 2012
i3 Research, India January 2010 - December 2010
i3 Research January 2008 - January 2010
i3 research 2008 - 2008
Skills
Cardiovascular Disease, CDISC, Transplant, Clinical Monitoring, Alzheimer's disease, Electronic Submissions, Clinical Development, Therapeutic Areas, ICH-GCP, Pharmacovigilance, GCP, Clinical Trials, CTMS, CRO, EDC, Clinical Operations
Education
Guru Nanak Dev University 2002 — 2005
M.Sc, Chemistry
INC Research 2013 - Present
INC Research December 2010 - October 2012
i3 Research, India January 2010 - December 2010
i3 Research January 2008 - January 2010
i3 research 2008 - 2008
Skills
Cardiovascular Disease, CDISC, Transplant, Clinical Monitoring, Alzheimer's disease, Electronic Submissions, Clinical Development, Therapeutic Areas, ICH-GCP, Pharmacovigilance, GCP, Clinical Trials, CTMS, CRO, EDC, Clinical Operations
Education
Guru Nanak Dev University 2002 — 2005
M.Sc, Chemistry
Nancy Costello, Ph.D.'s i3 Research Experience 2006 - 2008
Job Senior Contracts and Proposals Manager at Quanticate
Industry Pharmaceuticals
Experience
Quanticate August 2015 - Present
Psychiatric and Psychological Associates of Durham 2002 - Present
Quintiles July 2013 - August 2015
inVentiv Health September 2008 - July 2013
i3 Research 2006 - 2008
University of North Carolina at Chapel Hill 1996 - 2001
Durham VA 1996 - 1997
Skills
Clinical Research, Oncology, CRO, Clinical Trials, Clinical Development, SharePoint, Proposal Writing, Business Process..., CTMS, Process Improvement, Neuroscience, Psychometrics, Health Psychology, Databases, Budget Process, Cardiovascular, Therapeutic Areas, EDC, Clinical Monitoring, Drug Development, Pharmaceutical Industry, GCP, Medical Writing, Psychiatry, Diabetes, Infectious Diseases, Neurology, Pharmacology, Management, Life Sciences
Education
University of Miami 1992 — 1996
PhD, Health Psychology
Albany Medical College 1983 — 1989
PhD, Pharmacology
Le Moyne College 1979 — 1983
BS, Biology
Quanticate August 2015 - Present
Psychiatric and Psychological Associates of Durham 2002 - Present
Quintiles July 2013 - August 2015
inVentiv Health September 2008 - July 2013
i3 Research 2006 - 2008
University of North Carolina at Chapel Hill 1996 - 2001
Durham VA 1996 - 1997
Skills
Clinical Research, Oncology, CRO, Clinical Trials, Clinical Development, SharePoint, Proposal Writing, Business Process..., CTMS, Process Improvement, Neuroscience, Psychometrics, Health Psychology, Databases, Budget Process, Cardiovascular, Therapeutic Areas, EDC, Clinical Monitoring, Drug Development, Pharmaceutical Industry, GCP, Medical Writing, Psychiatry, Diabetes, Infectious Diseases, Neurology, Pharmacology, Management, Life Sciences
Education
University of Miami 1992 — 1996
PhD, Health Psychology
Albany Medical College 1983 — 1989
PhD, Pharmacology
Le Moyne College 1979 — 1983
BS, Biology
Carolyn Connelly's i3 Research Experience January 2002 - September 2002
Job Director, Clinical and Regulatory Affairs at Keryx Biopharmaceuticals
Industry Pharmaceuticals
Experience
Akebia Therapeutics 2015 - Present
Keryx Biopharmaceuticals March 2007 - 2014
Keryx Biopharmaceuticals August 2004 - March 2007
i3 Research January 2002 - September 2002
Skills
Neurology, Psychiatry, GI, Clinical Research, Regulatory Affairs, EDC, CTMS, Oncology, Clinical Trials, CRO, GCP, Clinical Development, ICH-GCP, Clinical Monitoring, Therapeutic Areas, Biotechnology, Pharmaceutical Industry
Education
Brown University 1993 — 1997
BA, Psychology
Akebia Therapeutics 2015 - Present
Keryx Biopharmaceuticals March 2007 - 2014
Keryx Biopharmaceuticals August 2004 - March 2007
i3 Research January 2002 - September 2002
Skills
Neurology, Psychiatry, GI, Clinical Research, Regulatory Affairs, EDC, CTMS, Oncology, Clinical Trials, CRO, GCP, Clinical Development, ICH-GCP, Clinical Monitoring, Therapeutic Areas, Biotechnology, Pharmaceutical Industry
Education
Brown University 1993 — 1997
BA, Psychology
Katie Chappell's i3 Research Experience September 2004 - June 2006
Job Open to reviewing employment opportunities
Industry Research
Experience
PAREXEL April 2012 - Present
PAREXEL April 2012 - Present
Biologics, Inc. May 2009 - March 2012
SRA (Constella Group) July 2006 - January 2009
SRA International (Constella) 2006 - 2009
SRA International 2006 - 2009
i3 Research September 2004 - June 2006
Charles River/Inveresk/PharmaResearch 1999 - 2004
GSK 1998 - 1999
B&GC--Pitt Co. 1992 - 1997
Skills
CRO, Clinical Monitoring, ICH-GCP, Clinical Research, Oncology, Clinical Development, Therapeutic Areas, Infectious Diseases, Clinical Data Management, Pharmaceutical Industry, Inform, Protocol, Sop, Regulatory Submissions, Patient Recruitment, Clinical Operations, Regulatory Affairs, Cardiology, Biotechnology
Education
East Carolina University 1991 — 1995
BA, Psychology
PAREXEL April 2012 - Present
PAREXEL April 2012 - Present
Biologics, Inc. May 2009 - March 2012
SRA (Constella Group) July 2006 - January 2009
SRA International (Constella) 2006 - 2009
SRA International 2006 - 2009
i3 Research September 2004 - June 2006
Charles River/Inveresk/PharmaResearch 1999 - 2004
GSK 1998 - 1999
B&GC--Pitt Co. 1992 - 1997
Skills
CRO, Clinical Monitoring, ICH-GCP, Clinical Research, Oncology, Clinical Development, Therapeutic Areas, Infectious Diseases, Clinical Data Management, Pharmaceutical Industry, Inform, Protocol, Sop, Regulatory Submissions, Patient Recruitment, Clinical Operations, Regulatory Affairs, Cardiology, Biotechnology
Education
East Carolina University 1991 — 1995
BA, Psychology
Lois Whitcher's i3 Research Experience 2001 - 2002
Job Sr Manager, Research Services at ICON plc
Industry Research
Experience
ICON plc April 2013 - Present
Quintiles 2009 - April 2013
SRA/Constella Group 2002 - 2009
RPS 2002 - 2002
i3 Research 2001 - 2002
LPW Consulting 1995 - 2001
GlaxoSmithKline 1989 - 1995
Clinical Research International 1987 - 1989
Education
West Virginia Wesleyan College 1976 — 1980
BS, Nursing
Florida International University
MHSA, Health Services Administration
ICON plc April 2013 - Present
Quintiles 2009 - April 2013
SRA/Constella Group 2002 - 2009
RPS 2002 - 2002
i3 Research 2001 - 2002
LPW Consulting 1995 - 2001
GlaxoSmithKline 1989 - 1995
Clinical Research International 1987 - 1989
Education
West Virginia Wesleyan College 1976 — 1980
BS, Nursing
Florida International University
MHSA, Health Services Administration
Catherine Dunne's i3 Research Experience January 2008 - December 2009
Job Regulatory Affairs
Industry Pharmaceuticals
Experience
Ipsen January 2010 - July 2011
i3 Research January 2008 - December 2009
Pfizer Pharmaceuticals September 1998 - December 2007
Education
Dublin City University 1994 — 1998
BSc
Ipsen January 2010 - July 2011
i3 Research January 2008 - December 2009
Pfizer Pharmaceuticals September 1998 - December 2007
Education
Dublin City University 1994 — 1998
BSc
Donna Walton's i3 Research Experience November 2006 - July 2008
Job Senior CRA (Homebased) at Chiltern
Industry Pharmaceuticals
Experience
Chiltern August 2015 - Present
Clinipace Worldwide (formerly Paragon Biomedical) August 2012 - August 2015
PRA International October 2011 - August 2012
Quintiles August 2008 - September 2011
i3 Research November 2006 - July 2008
PAREXEL June 2006 - October 2006
Lineberry Research Associates August 2001 - June 2006
PharmaLinkFHI 2000 - 2001
Cardinal Health (was Magellan Laboratories) 1997 - 2000
GlaxoSmithKline (was Burroughs Wellcome Pharmaceuticals Co.) 1985 - 1992
Skills
Therapeutic Areas, Clinical Trials, Infectious Diseases, Protocol, Vaccines, Psychiatry, Clinical Research..., Central Nervous System, Quality Assurance, CRO, GCP, Clinical Monitoring, CTMS, Clinical Research, ICH-GCP, EDC
Education
Durham Technical College
Associates 2 year degree, Clinical Trials Research
Elon University
Bachelors Degrees (Double Major), Chemistry & Biology
Chiltern August 2015 - Present
Clinipace Worldwide (formerly Paragon Biomedical) August 2012 - August 2015
PRA International October 2011 - August 2012
Quintiles August 2008 - September 2011
i3 Research November 2006 - July 2008
PAREXEL June 2006 - October 2006
Lineberry Research Associates August 2001 - June 2006
PharmaLinkFHI 2000 - 2001
Cardinal Health (was Magellan Laboratories) 1997 - 2000
GlaxoSmithKline (was Burroughs Wellcome Pharmaceuticals Co.) 1985 - 1992
Skills
Therapeutic Areas, Clinical Trials, Infectious Diseases, Protocol, Vaccines, Psychiatry, Clinical Research..., Central Nervous System, Quality Assurance, CRO, GCP, Clinical Monitoring, CTMS, Clinical Research, ICH-GCP, EDC
Education
Durham Technical College
Associates 2 year degree, Clinical Trials Research
Elon University
Bachelors Degrees (Double Major), Chemistry & Biology
Becky Fishman's i3 Research Experience November 2005 - October 2006
Job Senior Medical Writer at INC Research
Industry Pharmaceuticals
Experience
INC Research September 2014 - Present
INC Research March 2012 - September 2014
Novella Clinical April 2009 - March 2012
INC Research June 2007 - February 2009
INC Research October 2006 - June 2007
i3 Research November 2005 - October 2006
Charles River Laboratories Clinical Services/Inveresk/PharmaResearch Corporation July 1999 - October 2005
Skills
CRO, Clinical Trials, GCP, Medical Writing, Pharmacovigilance, Oncology, Clinical Research, Protocol, Infectious Diseases, Drug Safety, Sop, Cardiology, Report Writing, Therapeutic Areas, Adverse Event Reporting, Narrative, Writing, Technical Writing, Adverse Events, Clinical Protocols, Study Reports, CSRs, Clinical Study Design, Factor Analysis, Phase 2, Pharmacokinetics, Phase I
Education
University of North Carolina at Chapel Hill 1995 — 1997
MHA, Healthcare Administration
Emory University 1989 — 1993
BA, French Literature, Political Science
INC Research September 2014 - Present
INC Research March 2012 - September 2014
Novella Clinical April 2009 - March 2012
INC Research June 2007 - February 2009
INC Research October 2006 - June 2007
i3 Research November 2005 - October 2006
Charles River Laboratories Clinical Services/Inveresk/PharmaResearch Corporation July 1999 - October 2005
Skills
CRO, Clinical Trials, GCP, Medical Writing, Pharmacovigilance, Oncology, Clinical Research, Protocol, Infectious Diseases, Drug Safety, Sop, Cardiology, Report Writing, Therapeutic Areas, Adverse Event Reporting, Narrative, Writing, Technical Writing, Adverse Events, Clinical Protocols, Study Reports, CSRs, Clinical Study Design, Factor Analysis, Phase 2, Pharmacokinetics, Phase I
Education
University of North Carolina at Chapel Hill 1995 — 1997
MHA, Healthcare Administration
Emory University 1989 — 1993
BA, French Literature, Political Science
Tracy Shearer's i3 Research Experience 1999 - 2005
Job Clinical Research Consultant Shearer Consulting Inc.
Industry Pharmaceuticals
Experience
Shearer Consulting Inc. June 2008 - Present
ASTELLAS - (Contractor) 2006 - 2012
i3 Research 1999 - 2005
Education
East Carolina University
BSN, Nursing
Shearer Consulting Inc. June 2008 - Present
ASTELLAS - (Contractor) 2006 - 2012
i3 Research 1999 - 2005
Education
East Carolina University
BSN, Nursing
Alyson Lineberry's i3 Research Experience May 2009 - March 2010
Job Associate Director, Clinical Operations at Salix Pharmaceuticals
Industry Pharmaceuticals
Experience
Salix Pharmaceuticals January 2015 - Present
Salix Pharmaceuticals January 2014 - January 2015
Salix Pharmaceuticals April 2010 - January 2014
i3 Research May 2009 - March 2010
Constella Group (formerly Lineberry Research Associates) May 1999 - March 2009
Education
Campbell University 1995 — 1999
BS, Pharmaceutical Sciences
Salix Pharmaceuticals January 2015 - Present
Salix Pharmaceuticals January 2014 - January 2015
Salix Pharmaceuticals April 2010 - January 2014
i3 Research May 2009 - March 2010
Constella Group (formerly Lineberry Research Associates) May 1999 - March 2009
Education
Campbell University 1995 — 1999
BS, Pharmaceutical Sciences
Helen Russo, M.Sc.'s i3 Research Experience 2010 - 2011
Job consultant at hmr enterprises
Industry Pharmaceuticals
Experience
hmr enterprises March 1998 - Present
i3 Research 2010 - 2011
InVentiv 2009 - 2009
InVentiv 2009 - 2009
InVentiv 2009 - 2009
Pharmaco 1996 - 1998
PPD 1996 - 1998
Skills
Clinical Trials, Neurology, Oncology, Clinical Research, Cardiology, Sop, FDA, Pharmaceutical Industry, Alzheimer's disease, Data Management, Clinical Monitoring, Protocol, CRO, CTMS, Clinical Development, Regulatory Affairs, Biotechnology, Medical Writing, GCP, EDC, ICH-GCP, Infectious Diseases, Therapeutic Areas, Regulatory Submissions, Medical Devices, Pharmacovigilance, Pharmacovi
Education
Arizona State University 2013 — 2015
Master of Science (M.Sc.), Clinical Research Management, 4.0
San Diego State University-California State University 1987 — 1989
BA, Communication Disorders
hmr enterprises March 1998 - Present
i3 Research 2010 - 2011
InVentiv 2009 - 2009
InVentiv 2009 - 2009
InVentiv 2009 - 2009
Pharmaco 1996 - 1998
PPD 1996 - 1998
Skills
Clinical Trials, Neurology, Oncology, Clinical Research, Cardiology, Sop, FDA, Pharmaceutical Industry, Alzheimer's disease, Data Management, Clinical Monitoring, Protocol, CRO, CTMS, Clinical Development, Regulatory Affairs, Biotechnology, Medical Writing, GCP, EDC, ICH-GCP, Infectious Diseases, Therapeutic Areas, Regulatory Submissions, Medical Devices, Pharmacovigilance, Pharmacovi
Education
Arizona State University 2013 — 2015
Master of Science (M.Sc.), Clinical Research Management, 4.0
San Diego State University-California State University 1987 — 1989
BA, Communication Disorders
Kevin Hinnant's i3 Research Experience September 2006 - September 2007
Job Senior Clinical Project Manager at Quintiles
Industry Pharmaceuticals
Experience
Quintiles October 2011 - Present
INC Research October 2007 - October 2011
i3 Research September 2006 - September 2007
PPD August 2005 - August 2006
PPD April 2002 - August 2005
PPD August 2001 - August 2002
PPD August 1997 - August 2002
Skills
Hypertension, Asthma, Neurology, Respiration, Immunology
Education
East Carolina University 2002 — 2005
Nursing, Nursing
Campbell University 1998 — 2002
Biology, Biology
Quintiles October 2011 - Present
INC Research October 2007 - October 2011
i3 Research September 2006 - September 2007
PPD August 2005 - August 2006
PPD April 2002 - August 2005
PPD August 2001 - August 2002
PPD August 1997 - August 2002
Skills
Hypertension, Asthma, Neurology, Respiration, Immunology
Education
East Carolina University 2002 — 2005
Nursing, Nursing
Campbell University 1998 — 2002
Biology, Biology
Lisa Philipsek's i3 Research Experience January 2008 - June 2008
Job Insurance Professional
Industry Insurance
Experience
i3 Research January 2008 - June 2008
St. Catherine University 2006 - 2008
Ingenix 2003 - 2005
Skills
Data Analysis, Insurance, Customer Service, Data Entry, Health Insurance
Education
Ball State University
MS, Wellness Management
St. Cloud State University
BA, Anthropology
i3 Research January 2008 - June 2008
St. Catherine University 2006 - 2008
Ingenix 2003 - 2005
Skills
Data Analysis, Insurance, Customer Service, Data Entry, Health Insurance
Education
Ball State University
MS, Wellness Management
St. Cloud State University
BA, Anthropology
Joel Oconer, MD, RN's i3 Research Experience March 2011 - June 2012
Job Clinical Research Consultant at INC Research
Industry Research
Experience
INC Research April 2015 - Present
Salix Pharmaceuticals May 2014 - April 2015
PRA International January 2013 - April 2014
PSI CRO AG June 2012 - January 2013
i3 Research March 2011 - June 2012
i3 Research December 2007 - March 2011
MDS Pharma Services February 2006 - November 2007
Advanced Clinical Research Institute June 2002 - February 2006
Medical Research Associates November 2001 - June 2002
Los Baños Doctors Hospital November 1999 - April 2000
Skills
CTMS, Clinical Monitoring, GCP, CRO, ICH-GCP, EDC, Clinical Trials, Clinical Development, Therapeutic Areas, Clinical Data Management, Oncology, Clinical Operations, Infectious Diseases, Regulatory Submissions, Hematology, Dermatology, Neuroscience
Education
Excelsior College 2002 — 2003
Associate of Science (A.S.), Registered Nursing, Nursing Administration, Nursing Research and Clinical Nursing
University of Santo Tomas 1994 — 1998
Doctor of Medicine, Medicine
University of Santo Tomas 1990 — 1994
Bachelor of Science, Medical Technology
INC Research April 2015 - Present
Salix Pharmaceuticals May 2014 - April 2015
PRA International January 2013 - April 2014
PSI CRO AG June 2012 - January 2013
i3 Research March 2011 - June 2012
i3 Research December 2007 - March 2011
MDS Pharma Services February 2006 - November 2007
Advanced Clinical Research Institute June 2002 - February 2006
Medical Research Associates November 2001 - June 2002
Los Baños Doctors Hospital November 1999 - April 2000
Skills
CTMS, Clinical Monitoring, GCP, CRO, ICH-GCP, EDC, Clinical Trials, Clinical Development, Therapeutic Areas, Clinical Data Management, Oncology, Clinical Operations, Infectious Diseases, Regulatory Submissions, Hematology, Dermatology, Neuroscience
Education
Excelsior College 2002 — 2003
Associate of Science (A.S.), Registered Nursing, Nursing Administration, Nursing Research and Clinical Nursing
University of Santo Tomas 1994 — 1998
Doctor of Medicine, Medicine
University of Santo Tomas 1990 — 1994
Bachelor of Science, Medical Technology
XiaoLi (Nina) Gao's i3 Research Experience July 2002 - November 2004
Job Lead Data Manager at Minnkind Corp.
Industry Biotechnology
Experience
Mainnkind Corp. January 2011 - October 2014
Medarex Inc October 2005 - December 2010
Novartis November 2004 - October 2005
i3 Research July 2002 - November 2004
Net2phone, Inc., March 2000 - August 2001
First Affiliated Hospital of Xi’an Jiaotong University, Medical School December 1982 - November 1996
Skills
Clinical Data Management, Oracle Clinical, EDC, Sop, CDISC, Clinical Trials, GCP, Medical Coding, 21 CFR Part 11, Protocol, ICH-GCP, Clinical Development, CRO, CRF design, Data Management, Computer System..., Oncology, CTMS, Pharmaceutical Industry, Biotechnology, FDA, Validation, Clinical Research, Therapeutic Areas
Education
City University of New York City College 1998 — 2000
Master, Computer science
Xi'an Jiaotong University, Medical School 1977 — 1983
Doctor of Medicine (M.D.), Medicine
Mainnkind Corp. January 2011 - October 2014
Medarex Inc October 2005 - December 2010
Novartis November 2004 - October 2005
i3 Research July 2002 - November 2004
Net2phone, Inc., March 2000 - August 2001
First Affiliated Hospital of Xi’an Jiaotong University, Medical School December 1982 - November 1996
Skills
Clinical Data Management, Oracle Clinical, EDC, Sop, CDISC, Clinical Trials, GCP, Medical Coding, 21 CFR Part 11, Protocol, ICH-GCP, Clinical Development, CRO, CRF design, Data Management, Computer System..., Oncology, CTMS, Pharmaceutical Industry, Biotechnology, FDA, Validation, Clinical Research, Therapeutic Areas
Education
City University of New York City College 1998 — 2000
Master, Computer science
Xi'an Jiaotong University, Medical School 1977 — 1983
Doctor of Medicine (M.D.), Medicine
Anna Battaglia's i3 Research Experience January 2000 - September 2001
Job Director Study Feasibility and Patient RecruitmentGlobal Operations
Industry Pharmaceuticals
Experience
Allergan March 2009 - Present
Eisai Medical Research 2006 - 2009
Novartis 2001 - 2006
i3 Research January 2000 - September 2001
Schering-Plough Research Institute 1993 - 2000
Berlex Biosciences 1986 - 1993
Sandoz 1984 - 1986
Skills
Commercialization, Pharmaceutical Industry, Clinical Development, Oncology, Clinical Trials, Biotechnology, CRO, Drug Development, FDA, Cardiology, Neurology, Account Management, Strategic Planning, Sop, Regulatory Submissions, Regulatory Affairs, Quality System, Clinical Operations, CTMS, Clinical Data Management, Clinical Research
Education
Fairleigh Dickinson University
MBA, International Business
Allergan March 2009 - Present
Eisai Medical Research 2006 - 2009
Novartis 2001 - 2006
i3 Research January 2000 - September 2001
Schering-Plough Research Institute 1993 - 2000
Berlex Biosciences 1986 - 1993
Sandoz 1984 - 1986
Skills
Commercialization, Pharmaceutical Industry, Clinical Development, Oncology, Clinical Trials, Biotechnology, CRO, Drug Development, FDA, Cardiology, Neurology, Account Management, Strategic Planning, Sop, Regulatory Submissions, Regulatory Affairs, Quality System, Clinical Operations, CTMS, Clinical Data Management, Clinical Research
Education
Fairleigh Dickinson University
MBA, International Business
Kalyan Marada's i3 Research Experience January 2010 - May 2010
Job Documentum Technical Lead / Architect
Industry Computer Software
Experience
AbbVie March 2015 - Present
Massachusetts Gaming Commission November 2013 - February 2015
Verizon June 2013 - October 2013
Liberty Mutual Insurance April 2013 - June 2013
FDA September 2012 - April 2013
Blue Cross Blue Shield of Massachusetts June 2012 - September 2012
Sallie Mae September 2010 - June 2012
Fairfax County Government June 2010 - September 2010
i3 Research January 2010 - May 2010
Standard & Poor's April 2009 - December 2009
Skills
Captiva, Solution Architecture, Documentum, WDK, Document Management, Enterprise Content..., Java Enterprise Edition, XML, DQL, Webtop, SOA, Enterprise Architecture, Requirements Analysis, Weblogic, xCP, WebLogic, Consulting, SDLC, SQL
Education
Jawaharlal Nehru Technological University
Bachelor's degree, Computer Science
AbbVie March 2015 - Present
Massachusetts Gaming Commission November 2013 - February 2015
Verizon June 2013 - October 2013
Liberty Mutual Insurance April 2013 - June 2013
FDA September 2012 - April 2013
Blue Cross Blue Shield of Massachusetts June 2012 - September 2012
Sallie Mae September 2010 - June 2012
Fairfax County Government June 2010 - September 2010
i3 Research January 2010 - May 2010
Standard & Poor's April 2009 - December 2009
Skills
Captiva, Solution Architecture, Documentum, WDK, Document Management, Enterprise Content..., Java Enterprise Edition, XML, DQL, Webtop, SOA, Enterprise Architecture, Requirements Analysis, Weblogic, xCP, WebLogic, Consulting, SDLC, SQL
Education
Jawaharlal Nehru Technological University
Bachelor's degree, Computer Science
angela julian's i3 Research Experience August 2006 - May 2007
Job CRA at Research Point Global
Industry Research
Experience
Research Point Global May 2013 - Present
Aerotek 2012 - 2013
PharmaNet/i3 Strategic Resourcing/InventivHealth Clinical August 2011 - October 2012
INC Research December 2009 - August 2011
Premier Research Group Limited June 2007 - October 2009
i3 Research August 2006 - May 2007
PPD March 2004 - July 2006
SCIREX Corporation April 2001 - March 2004
Capital Dialysis of Texas August 2000 - March 2001
Geary Community Hospital December 1999 - August 2000
Skills
Clinical Monitoring, EDC, CTMS, ICH-GCP, GCP, CRO, Clinical Trials, Clinical Research
Education
Washburn University 1997 — 1999
B.S, Nursing
Kansas State University 1994 — 1995
B.S, Life Science
Hutchinson Community College 1992 — 1993
A.A, General Studies
Research Point Global May 2013 - Present
Aerotek 2012 - 2013
PharmaNet/i3 Strategic Resourcing/InventivHealth Clinical August 2011 - October 2012
INC Research December 2009 - August 2011
Premier Research Group Limited June 2007 - October 2009
i3 Research August 2006 - May 2007
PPD March 2004 - July 2006
SCIREX Corporation April 2001 - March 2004
Capital Dialysis of Texas August 2000 - March 2001
Geary Community Hospital December 1999 - August 2000
Skills
Clinical Monitoring, EDC, CTMS, ICH-GCP, GCP, CRO, Clinical Trials, Clinical Research
Education
Washburn University 1997 — 1999
B.S, Nursing
Kansas State University 1994 — 1995
B.S, Life Science
Hutchinson Community College 1992 — 1993
A.A, General Studies
Dennis Bahm's i3 Research Experience July 2010 - June 2012
Job Associate Director at PPD
Industry Pharmaceuticals
Experience
PPD July 2012 - Present
i3 Research July 2010 - June 2012
Pfizer (Wyeth) February 2006 - July 2010
Pfizer 2001 - 2005
Pfizer (Warner-Lambert/Parke-Davis) 1999 - 2001
Warner-Lambert/Parke-Davis 1995 - 1999
Warner-Lambert/Parke-Davis 1989 - 1995
Warner-Lambert/Parke-Davis 1988 - 1989
Warner-Lambert/Parke-Davis 1986 - 1988
Mercy-Memorial Medical Center 1978 - 1986
Skills
Regulatory Requirements, CRO, GCP, Lifesciences, Management, Cardiology, Regulatory Submissions, Psychiatry, Budgets, Medical Affairs, EDC, Neurology, Pain Management, Pharmacovigilance, Clinical Operations, Clinical Data Management, Nursing, Software Documentation, Medical Devices
Education
University of Michigan 1989 — 1991
Masters of Science, Clinical Research Design and Statistical Analysis
Ferris State University 1974 — 1979
Bachelors Degree In Pharmacy, Pharmacy
PPD July 2012 - Present
i3 Research July 2010 - June 2012
Pfizer (Wyeth) February 2006 - July 2010
Pfizer 2001 - 2005
Pfizer (Warner-Lambert/Parke-Davis) 1999 - 2001
Warner-Lambert/Parke-Davis 1995 - 1999
Warner-Lambert/Parke-Davis 1989 - 1995
Warner-Lambert/Parke-Davis 1988 - 1989
Warner-Lambert/Parke-Davis 1986 - 1988
Mercy-Memorial Medical Center 1978 - 1986
Skills
Regulatory Requirements, CRO, GCP, Lifesciences, Management, Cardiology, Regulatory Submissions, Psychiatry, Budgets, Medical Affairs, EDC, Neurology, Pain Management, Pharmacovigilance, Clinical Operations, Clinical Data Management, Nursing, Software Documentation, Medical Devices
Education
University of Michigan 1989 — 1991
Masters of Science, Clinical Research Design and Statistical Analysis
Ferris State University 1974 — 1979
Bachelors Degree In Pharmacy, Pharmacy
Rosemary Homareau's i3 Research Experience 2007 - 2010
Job Clinical Research Project Manager
Industry Pharmaceuticals
Experience
i3 Research 2007 - 2010
AstraZeneca Canada 2003 - 2007
Pfizer Pharmaceuticals 1998 - 2003
Novartis 1995 - 1998
Janssen Pharmaceutica 1994 - 1995
Ciba-Geigy 1990 - 1994
Education
Brock University
Honours BSc.
i3 Research 2007 - 2010
AstraZeneca Canada 2003 - 2007
Pfizer Pharmaceuticals 1998 - 2003
Novartis 1995 - 1998
Janssen Pharmaceutica 1994 - 1995
Ciba-Geigy 1990 - 1994
Education
Brock University
Honours BSc.
Richard Margolin's i3 Research Experience 2005 - 2008
Job Vice President, Clinical Development at CereSpir, Inc.
Industry Pharmaceuticals
Experience
CereSpir, Inc. November 2013 - Present
JANSSEN Alzheimer Immunotherapy May 2011 - November 2013
Merck Research Laboratories January 2008 - May 2011
i3 Research 2005 - 2008
Keck USC School of Medicine September 2000 - June 2005
Vanderbilt University Medical Center 1997 - 2001
National Institutes of Health 1982 - 1984
Skills
Neuroscience, Biomarkers, Medicine, Drug Development, CRO, Clinical Study Design, Translational Medicine, Psychiatry, Clinical Research, Science, Clinical Development, Treatment, Clinical Trials, Pharmacology, Clinical Pharmacology, Drug Discovery, Neurology, Alzheimer's disease, Pharmaceutical Industry, Translational Research, Medical Research, Lifesciences, Biotechnology, Sop, Immunology, Infectious Diseases, Laboratory, FDA
Education
University of California, Irvine - College of Medicine 1974 — 1977
MD
Harvard University 1968 — 1974
AB, Psychophysiology
CereSpir, Inc. November 2013 - Present
JANSSEN Alzheimer Immunotherapy May 2011 - November 2013
Merck Research Laboratories January 2008 - May 2011
i3 Research 2005 - 2008
Keck USC School of Medicine September 2000 - June 2005
Vanderbilt University Medical Center 1997 - 2001
National Institutes of Health 1982 - 1984
Skills
Neuroscience, Biomarkers, Medicine, Drug Development, CRO, Clinical Study Design, Translational Medicine, Psychiatry, Clinical Research, Science, Clinical Development, Treatment, Clinical Trials, Pharmacology, Clinical Pharmacology, Drug Discovery, Neurology, Alzheimer's disease, Pharmaceutical Industry, Translational Research, Medical Research, Lifesciences, Biotechnology, Sop, Immunology, Infectious Diseases, Laboratory, FDA
Education
University of California, Irvine - College of Medicine 1974 — 1977
MD
Harvard University 1968 — 1974
AB, Psychophysiology
Stephanie MacLaughlin's i3 Research Experience 2010 - 2011
Job Clinical Operations Leader at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL February 2014 - Present
PRA International June 2011 - February 2014
i3 Research 2010 - 2011
ICON Clinical Research 2006 - 2010
ICON Clinical Research 2004 - 2006
ICON Clinical Research 2003 - 2004
ICON Clinical Research 2002 - 2003
Skills
CRO, CTMS, Clinical Monitoring, GCP, ICH-GCP, EDC, Clinical Trials, Clinical Development, Therapeutic Areas, Oncology, Clinical Data Management, Infectious Diseases, Regulatory Submissions, Clinical Research, Oracle Clinical
Education
Belmont University
BS, Biology, Chemistry
PAREXEL February 2014 - Present
PRA International June 2011 - February 2014
i3 Research 2010 - 2011
ICON Clinical Research 2006 - 2010
ICON Clinical Research 2004 - 2006
ICON Clinical Research 2003 - 2004
ICON Clinical Research 2002 - 2003
Skills
CRO, CTMS, Clinical Monitoring, GCP, ICH-GCP, EDC, Clinical Trials, Clinical Development, Therapeutic Areas, Oncology, Clinical Data Management, Infectious Diseases, Regulatory Submissions, Clinical Research, Oracle Clinical
Education
Belmont University
BS, Biology, Chemistry
Cheryl Arvay's i3 Research Experience May 2010 - January 2012
Job Senior Project Manager at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL March 2012 - Present
i3 Research May 2010 - January 2012
Clinsys Clinical Research October 2002 - March 2010
Schering-Plough Research Institute December 1991 - October 2002
Skills
CRO, Clinical Trial..., Protocol Development, GCP, Clinical Development, Clinical Research, EDC, Clinical Trials, Oncology, Infectious Diseases, Asthma, SOP, Pharmaceuticals, Neurology, Cardiology, Healthcare, Cross-functional Team..., Clinical Monitoring, Nursing
Education
University of Pittsburgh 1987 — 1991
MPH, Epidemiology
Carlow College 1973 — 1977
BSN, Nursing
PAREXEL March 2012 - Present
i3 Research May 2010 - January 2012
Clinsys Clinical Research October 2002 - March 2010
Schering-Plough Research Institute December 1991 - October 2002
Skills
CRO, Clinical Trial..., Protocol Development, GCP, Clinical Development, Clinical Research, EDC, Clinical Trials, Oncology, Infectious Diseases, Asthma, SOP, Pharmaceuticals, Neurology, Cardiology, Healthcare, Cross-functional Team..., Clinical Monitoring, Nursing
Education
University of Pittsburgh 1987 — 1991
MPH, Epidemiology
Carlow College 1973 — 1977
BSN, Nursing
Patty Bebee's i3 Research Experience 2005 - 2006
Job Education Coordinator/Quality Assurance
Industry
Experience
University of Michigan Health System 2010 - Present
University of Michigan Health System 2007 - 2010
Kforce Inc September 2006 - March 2007
i3 Research 2005 - 2006
Education
Eastern Michigan University 2013 — 2015
Master's Degree, Clinical Research Administration
Concordia College
Bachelor's Degree, Health/Health Care Administration/Management
Washtena
Associate's Degree, Registered Nursing/Registered Nurse
University of Michigan Health System 2010 - Present
University of Michigan Health System 2007 - 2010
Kforce Inc September 2006 - March 2007
i3 Research 2005 - 2006
Education
Eastern Michigan University 2013 — 2015
Master's Degree, Clinical Research Administration
Concordia College
Bachelor's Degree, Health/Health Care Administration/Management
Washtena
Associate's Degree, Registered Nursing/Registered Nurse
Kathleen Hartnett-Heliger's i3 Research Experience 1998 - 2007
Job Business Manager at Instat Services, Inc.
Industry Pharmaceuticals
Experience
Instat Services, Inc. April 2007 - Present
i3 Research 1998 - 2007
Education
Centenary College 2004 — 2010
MBA, Business Administration
Instat Services, Inc. April 2007 - Present
i3 Research 1998 - 2007
Education
Centenary College 2004 — 2010
MBA, Business Administration
Brian Dean, MS's i3 Research Experience 2006 - 2007
Job Clinical Research Consultant at Dean Clinical Consulting, LLC
Industry Pharmaceuticals
Experience
Dean Clinical Consulting, LLC October 2014 - Present
Auxilium Pharmaceuticals January 2012 - September 2014
Auxilium Pharmaceuticals October 2008 - January 2012
Auxilium Pharmaceuticals 2007 - 2008
i3 Research 2006 - 2007
Omnicare Clinical Research 2001 - 2006
SCIREX Corporation 2000 - 2001
Clinicor, Inc. 1999 - 2000
Skills
CRO, Protocol, Biopharmaceuticals, 21 CFR Part 11, CTMS, Pharmaceutical Industry, Clinical Trials, GCP, Regulatory Affairs, GLP, Oncology, FDA, Vaccines, Clinical Research..., Clinical Development, Clinical Research, Informed Consent, Infectious Diseases, Clinical Data Management, Clinical Operations, EDC, Clinical Study Design, Medical Affairs, Lifesciences, Clinical Monitoring, Biotechnology, Therapeutic Areas, Drug Development, CRF design, Neurology, Regulatory Submissions, ICH-GCP, Medical Devices, Sop, Clinical Research..., Data Management, Regulatory Requirements, Life Sciences, SOP
Education
Drexel University College of Medicine 2010 — 2014
Master of Science (M.S.), Clinical Research Organization and Management, 4.0
Baylor University 1994 — 1998
Bachelor of Science (B.S.), Biology
Dean Clinical Consulting, LLC October 2014 - Present
Auxilium Pharmaceuticals January 2012 - September 2014
Auxilium Pharmaceuticals October 2008 - January 2012
Auxilium Pharmaceuticals 2007 - 2008
i3 Research 2006 - 2007
Omnicare Clinical Research 2001 - 2006
SCIREX Corporation 2000 - 2001
Clinicor, Inc. 1999 - 2000
Skills
CRO, Protocol, Biopharmaceuticals, 21 CFR Part 11, CTMS, Pharmaceutical Industry, Clinical Trials, GCP, Regulatory Affairs, GLP, Oncology, FDA, Vaccines, Clinical Research..., Clinical Development, Clinical Research, Informed Consent, Infectious Diseases, Clinical Data Management, Clinical Operations, EDC, Clinical Study Design, Medical Affairs, Lifesciences, Clinical Monitoring, Biotechnology, Therapeutic Areas, Drug Development, CRF design, Neurology, Regulatory Submissions, ICH-GCP, Medical Devices, Sop, Clinical Research..., Data Management, Regulatory Requirements, Life Sciences, SOP
Education
Drexel University College of Medicine 2010 — 2014
Master of Science (M.S.), Clinical Research Organization and Management, 4.0
Baylor University 1994 — 1998
Bachelor of Science (B.S.), Biology
Shannon Goodman's i3 Research Experience October 2008 - January 2012
Job Senior Clinical Monitoring Associate at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL January 2012 - Present
i3 Research October 2008 - January 2012
PPD August 2005 - October 2008
Southeastern Center for MH/DD/SAS July 2000 - August 2005
Skills
GCP, Clinical Trials, Clinical Research, Clinical Monitoring, Site Management
Education
Appalachian State University 1996 — 1998
MA, Special Education
Appalachian State University 1992 — 1996
BS, Psychology, Elementary Education
PAREXEL January 2012 - Present
i3 Research October 2008 - January 2012
PPD August 2005 - October 2008
Southeastern Center for MH/DD/SAS July 2000 - August 2005
Skills
GCP, Clinical Trials, Clinical Research, Clinical Monitoring, Site Management
Education
Appalachian State University 1996 — 1998
MA, Special Education
Appalachian State University 1992 — 1996
BS, Psychology, Elementary Education
Dalton Thibodeaux's i3 Research Experience 2002 - June 2007
Job Lead Clinical Site Manager at Alcon Laboratories, Inc.
Industry Pharmaceuticals
Experience
Alcon Laboratories, Inc. July 2007 - Present
i3 Research 2002 - June 2007
Quintiles 2000 - 2002
Skills
Clinical Monitoring, Clinical Trial..., ICH-GCP, GCP, EDC, Ophthalmology, Therapeutic areas, Clinical Trials, Clinical Research, Clinical Development, Phase I, Medical Devices, Clinical Operations, Diabetes, Rheumatoid Arthritis, IRB, 21 CFR Part 11, Protocol, Regulatory Submissions, Pharmaceutical Industry, CTMS, CAPA, Regulatory Affairs, Sop, CRO, Clinical Data Management, Pharmacovigilance, Therapeutic Areas, Drug Development, FDA, SOP
Education
Kansas State University 1992 — 1997
Bachelor of Science (B.S.), Pre-Medicine
Harrison Central High School 1984 — 1986
Alcon Laboratories, Inc. July 2007 - Present
i3 Research 2002 - June 2007
Quintiles 2000 - 2002
Skills
Clinical Monitoring, Clinical Trial..., ICH-GCP, GCP, EDC, Ophthalmology, Therapeutic areas, Clinical Trials, Clinical Research, Clinical Development, Phase I, Medical Devices, Clinical Operations, Diabetes, Rheumatoid Arthritis, IRB, 21 CFR Part 11, Protocol, Regulatory Submissions, Pharmaceutical Industry, CTMS, CAPA, Regulatory Affairs, Sop, CRO, Clinical Data Management, Pharmacovigilance, Therapeutic Areas, Drug Development, FDA, SOP
Education
Kansas State University 1992 — 1997
Bachelor of Science (B.S.), Pre-Medicine
Harrison Central High School 1984 — 1986
Evy Moreno, BSHS, CCRP's i3 Research Experience October 2010 - February 2011
Job Senior CRA at Inventiv Health Clinical
Industry Pharmaceuticals
Experience
inVentiv Health Clinical January 2012 - Present
E.M. Research Consulting, Inc March 2011 - January 2012
i3 Research October 2010 - February 2011
Q-Med Clinical Research, Inc. March 2009 - July 2010
Noven Pharmaceutical, Inc. March 2008 - October 2008
PharmaNet Development Group, Inc. June 2003 - July 2006
University of Miami November 2001 - May 2003
Skills
GCP, Clinical Trials, EDC, ICH-GCP, CRO, IRB, Remote Monitoring, Drug Accountability, Inform, Oracle Applications, Clinical Monitoring, Clinical Research, FDA, Clinical Development, Protocol, SOP
Education
Florida International University 2005 — 2009
BSHS, Health Sciences/Minor Health Service Administration
Miami Dade Community College 1999 — 2001
Associate, Science (Concentration on Health Information Management)
Miami Dade Community College
Associate of Arts
inVentiv Health Clinical January 2012 - Present
E.M. Research Consulting, Inc March 2011 - January 2012
i3 Research October 2010 - February 2011
Q-Med Clinical Research, Inc. March 2009 - July 2010
Noven Pharmaceutical, Inc. March 2008 - October 2008
PharmaNet Development Group, Inc. June 2003 - July 2006
University of Miami November 2001 - May 2003
Skills
GCP, Clinical Trials, EDC, ICH-GCP, CRO, IRB, Remote Monitoring, Drug Accountability, Inform, Oracle Applications, Clinical Monitoring, Clinical Research, FDA, Clinical Development, Protocol, SOP
Education
Florida International University 2005 — 2009
BSHS, Health Sciences/Minor Health Service Administration
Miami Dade Community College 1999 — 2001
Associate, Science (Concentration on Health Information Management)
Miami Dade Community College
Associate of Arts
Laura Loos's i3 Research Experience May 2007 - Present
Job Quality Assurance at i3 Research
Industry Pharmaceuticals
Experience
i3 Research May 2007 - Present
i3 Drug Safety 1997 - Present
Education
Jackson Community College 1983 — 1985
i3 Research May 2007 - Present
i3 Drug Safety 1997 - Present
Education
Jackson Community College 1983 — 1985
Norva Fisher's i3 Research Experience March 2004 - December 2006
Job Forest Research Institute
Industry Pharmaceuticals
Experience
ReSearch Pharmaceutical Services January 2007 - Present
i3 Research March 2004 - December 2006
PPD March 2002 - March 2004
Skills
Clinical Monitoring, EDC, Clinical Research..., CTMS, ICH-GCP, GCP, CRO, Therapeutic Areas
Education
Southern Illinois University, Carbondale 1976 — 1977
BA, Psychology
Eastern Illinois University 1975 — 1976
ReSearch Pharmaceutical Services January 2007 - Present
i3 Research March 2004 - December 2006
PPD March 2002 - March 2004
Skills
Clinical Monitoring, EDC, Clinical Research..., CTMS, ICH-GCP, GCP, CRO, Therapeutic Areas
Education
Southern Illinois University, Carbondale 1976 — 1977
BA, Psychology
Eastern Illinois University 1975 — 1976
Tara Odom's i3 Research Experience January 2008 - February 2010
Job Experienced data coordinator/manager with considerable experience within the CRO, Pharmaceutical, Biotech environment.
Industry Pharmaceuticals
Experience
Novartis June 2014 - Present
Various contract positions June 2010 - July 2014
Premier Research Group May 2009 - October 2010
i3 Research January 2008 - February 2010
Smith Hanley Consulting Group November 2006 - December 2007
Skills
Database Management, Clinical database..., Microsoft Excel, Word,..., Database Admin, EDC, Microsoft Excel, Oncology, Oracle Clinical, Inform, Data Management, CRO, Clinical Trials
Education
Campbell University 1993 — 1996
Psychology
Wake Technical Community College 1992 — 1993
Transfer student
Novartis June 2014 - Present
Various contract positions June 2010 - July 2014
Premier Research Group May 2009 - October 2010
i3 Research January 2008 - February 2010
Smith Hanley Consulting Group November 2006 - December 2007
Skills
Database Management, Clinical database..., Microsoft Excel, Word,..., Database Admin, EDC, Microsoft Excel, Oncology, Oracle Clinical, Inform, Data Management, CRO, Clinical Trials
Education
Campbell University 1993 — 1996
Psychology
Wake Technical Community College 1992 — 1993
Transfer student
Keasha Webb's i3 Research Experience January 2005 - August 2005
Job Clinical Research Associate at Omnyx, LLC
Industry Pharmaceuticals
Experience
Omnyx December 2013 - Present
Omnyx September 2013 - December 2013
LifeCell Corporation April 2013 - September 2013
Smith Hanley Consulting Group April 2011 - April 2013
ReSearch Pharmaceutical Services November 2010 - April 2011
ReSearch Pharmaceutical Services December 2008 - October 2010
Integrium Clinical June 2008 - November 2008
Smith Hanley Consulting Group September 2005 - June 2008
i3 Research January 2005 - August 2005
i3 Research April 1998 - January 2005
Skills
•Highly organized and..., •Ability to..., •Solid knowledge of..., •Proficient in..., CT.gov, Ariba, Impact,..., Clinical Trials, CRO, Regulatory Affairs, Clinical Data Management, FDA, Data Management, Pharmaceutical Industry, Sop, Clinical Operations, CTMS, GCP, Clinical Research, Clinical Study Design, Clinical Development
Education
The Chubb Institute 2002 — 2003
Certificate, Network Technician
Newark Business Training Institute 1997 — 1998
Certificate, Medical Office Skills
Bloomfield College 1988 — 1990
Sociology
Omnyx December 2013 - Present
Omnyx September 2013 - December 2013
LifeCell Corporation April 2013 - September 2013
Smith Hanley Consulting Group April 2011 - April 2013
ReSearch Pharmaceutical Services November 2010 - April 2011
ReSearch Pharmaceutical Services December 2008 - October 2010
Integrium Clinical June 2008 - November 2008
Smith Hanley Consulting Group September 2005 - June 2008
i3 Research January 2005 - August 2005
i3 Research April 1998 - January 2005
Skills
•Highly organized and..., •Ability to..., •Solid knowledge of..., •Proficient in..., CT.gov, Ariba, Impact,..., Clinical Trials, CRO, Regulatory Affairs, Clinical Data Management, FDA, Data Management, Pharmaceutical Industry, Sop, Clinical Operations, CTMS, GCP, Clinical Research, Clinical Study Design, Clinical Development
Education
The Chubb Institute 2002 — 2003
Certificate, Network Technician
Newark Business Training Institute 1997 — 1998
Certificate, Medical Office Skills
Bloomfield College 1988 — 1990
Sociology