Clinimetrics Research Associates
Industry: Company
DescriptionHeadquarters: Covington, KY Founded: 1988 Parent organizations: Omnicare, Theorem Clinical Research Inc. Subsidiary: Clinimetrics Global Development Inc
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Clinimetrics Research Associates Employees
Employee
Years
Job
Industry
Danielle Addison Danielle Addison's Clinimetrics Research Associates Experience March 2008 - June 2010
Job Senior Clinical Research Associate at PRA Health Sciences
Industry Pharmaceuticals
Experience
PRA Health Sciences March 2015 - Present
PRA International July 2013 - March 2015
PRA International April 2012 - July 2013
Theorem Clinical Research June 2011 - April 2012
Omnicare Clinical Research January 2011 - June 2011
Omnicare Clinical Research July 2010 - February 2011
Clinimetrics Research Associates March 2008 - June 2010
National University of Ireland, Galway June 2007 - August 2007
The University of Georgia 2006 - 2007
Skills
Clinical Monitoring, Clinical Research, Pharmaceutical Industry, Microbiology, Protein Chemistry, EDC, CTMS, Clinical Trials, PCR, Gel Electrophoresis, Clinical Development, GCP, ICH-GCP, CRO, Laboratory, Regulatory Submissions, Infectious Diseases, Clinical Data Management, Oncology
Education
The University of Georgia 2004 — 2007
BS, Microbiology
PRA Health Sciences March 2015 - Present
PRA International July 2013 - March 2015
PRA International April 2012 - July 2013
Theorem Clinical Research June 2011 - April 2012
Omnicare Clinical Research January 2011 - June 2011
Omnicare Clinical Research July 2010 - February 2011
Clinimetrics Research Associates March 2008 - June 2010
National University of Ireland, Galway June 2007 - August 2007
The University of Georgia 2006 - 2007
Skills
Clinical Monitoring, Clinical Research, Pharmaceutical Industry, Microbiology, Protein Chemistry, EDC, CTMS, Clinical Trials, PCR, Gel Electrophoresis, Clinical Development, GCP, ICH-GCP, CRO, Laboratory, Regulatory Submissions, Infectious Diseases, Clinical Data Management, Oncology
Education
The University of Georgia 2004 — 2007
BS, Microbiology
Dianne Conry's Clinimetrics Research Associates Experience 2001 - 2007
Job Consultant at Kranz & Associates
Industry Accounting
Experience
Kranz & Associates September 2010 - Present
UCSC Extension in Silicon Valley 1995 - Present
RoseRyan 2007 - 2010
Clinimetrics Research Associates 2001 - 2007
Accretive Solutions fka Horn Murdock Cole, an accounting, IT and finance consulting firm 1997 - 2001
Sony Electronics 1991 - 1996
PwC 1988 - 1991
Dictos Accountancy Corporation 1986 - 1988
Education
California State University, Fresno 1984 — 1988
BS, MS, Accounting
Kranz & Associates September 2010 - Present
UCSC Extension in Silicon Valley 1995 - Present
RoseRyan 2007 - 2010
Clinimetrics Research Associates 2001 - 2007
Accretive Solutions fka Horn Murdock Cole, an accounting, IT and finance consulting firm 1997 - 2001
Sony Electronics 1991 - 1996
PwC 1988 - 1991
Dictos Accountancy Corporation 1986 - 1988
Education
California State University, Fresno 1984 — 1988
BS, MS, Accounting
Daniel Estrella Daniel Estrella's Clinimetrics Research Associates Experience February 2008 - November 2009
Job Lead CRA at ProTrials Research
Industry Pharmaceuticals
Experience
ProTrials Research December 2011 - Present
Pedro Point Community Association 1995 - Present
Abbott Labs January 2010 - December 2011
Clinimetrics Research Associates February 2008 - November 2009
Genentech July 2007 - January 2008
Clinimetrics September 1993 - July 2007
Penederm, Inc. March 1991 - April 1993
Penederm, Inc. May 1988 - March 1991
Liposome Technology, Inc. October 1986 - May 1988
Bristol-Myers Products September 1985 - October 1986
Skills
Quality Assurance, Clinical Data Management, Clinical Trials, GCP, Therapeutic Areas, CRO, Clinical Research, EDC, Sop, Clinical Development, Protocol, CTMS, Clinical Operations, Clinical Monitoring, Clinical Study Design, SOP
Education
University of California, Santa Barbara 1980 — 1985
MA, Biology (Pharmacology emphasis)
San Francisco State University 1973 — 1979
BA, Biochemistry, Cell and Molecular Biology
ProTrials Research December 2011 - Present
Pedro Point Community Association 1995 - Present
Abbott Labs January 2010 - December 2011
Clinimetrics Research Associates February 2008 - November 2009
Genentech July 2007 - January 2008
Clinimetrics September 1993 - July 2007
Penederm, Inc. March 1991 - April 1993
Penederm, Inc. May 1988 - March 1991
Liposome Technology, Inc. October 1986 - May 1988
Bristol-Myers Products September 1985 - October 1986
Skills
Quality Assurance, Clinical Data Management, Clinical Trials, GCP, Therapeutic Areas, CRO, Clinical Research, EDC, Sop, Clinical Development, Protocol, CTMS, Clinical Operations, Clinical Monitoring, Clinical Study Design, SOP
Education
University of California, Santa Barbara 1980 — 1985
MA, Biology (Pharmacology emphasis)
San Francisco State University 1973 — 1979
BA, Biochemistry, Cell and Molecular Biology
Mark Hamada Mark Hamada's Clinimetrics Research Associates Experience October 2006 - November 2009
Job Manager, Clinical Quality at Abbott Vascular
Industry Medical Devices
Experience
Abbott Vascular August 2015 - Present
Abbott Vascular March 2011 - Present
Self-Employed December 2009 - March 2011
Clinimetrics Research Associates October 2006 - November 2009
Clinimetrics Research Associates April 2004 - October 2006
Self-Employed 2001 - 2004
Roche Diagnostics 1999 - 2000
Roche Diagnostics (formerly Boehringer Mannheim/Ciba Corning/Biotrack) 1995 - 1999
Ciba Corning Diagnostics (formerly Biotrack) 1993 - 1995
Ciba Corning Diagnostics 1992 - 1993
Skills
Clinical Data Management, FDA, Validation, GMP, 21 CFR Part 11, Sop, GCP, Clinical Trials, Quality Assurance, Quality System, Computer System..., ICH-GCP, Change Control, LIMS, Regulatory Submissions, EDC, Regulatory Affairs, Biotechnology, Document Management, Management, Medical Writing, Pharmaceutical Industry, Infectious Diseases, Leadership, Lifesciences, Quality Auditing, Drug Development, SDLC, ISO 13485, Biopharmaceuticals, CTMS, Project Management, Testing, CAPA, V&V, Quality Management, Pharmacovigilance, Program Management, Training, CRO, Technology Transfer, Manufacturing, Medical Devices, R&D, Software Documentation, Quality Control, Clinical Development, Clinical Research, Oncology, Clinical Monitoring
Education
University of California, Davis
B.S. Physiology
Abbott Vascular August 2015 - Present
Abbott Vascular March 2011 - Present
Self-Employed December 2009 - March 2011
Clinimetrics Research Associates October 2006 - November 2009
Clinimetrics Research Associates April 2004 - October 2006
Self-Employed 2001 - 2004
Roche Diagnostics 1999 - 2000
Roche Diagnostics (formerly Boehringer Mannheim/Ciba Corning/Biotrack) 1995 - 1999
Ciba Corning Diagnostics (formerly Biotrack) 1993 - 1995
Ciba Corning Diagnostics 1992 - 1993
Skills
Clinical Data Management, FDA, Validation, GMP, 21 CFR Part 11, Sop, GCP, Clinical Trials, Quality Assurance, Quality System, Computer System..., ICH-GCP, Change Control, LIMS, Regulatory Submissions, EDC, Regulatory Affairs, Biotechnology, Document Management, Management, Medical Writing, Pharmaceutical Industry, Infectious Diseases, Leadership, Lifesciences, Quality Auditing, Drug Development, SDLC, ISO 13485, Biopharmaceuticals, CTMS, Project Management, Testing, CAPA, V&V, Quality Management, Pharmacovigilance, Program Management, Training, CRO, Technology Transfer, Manufacturing, Medical Devices, R&D, Software Documentation, Quality Control, Clinical Development, Clinical Research, Oncology, Clinical Monitoring
Education
University of California, Davis
B.S. Physiology
Pheadra Bright Pheadra Bright's Clinimetrics Research Associates Experience 2004 - 2009
Job Senior Proposal Developer at Synteract, Inc.
Industry Research
Experience
Synteract, Inc. October 2012 - Present
Quintiles April 2011 - October 2012
Quintiles November 2010 - April 2011
Aerotek May 2010 - November 2010
Clinimetrics Research Associates 2004 - 2009
Clinimetrics 2001 - 2004
Ingenix 1999 - 2001
Worldwide Clinical Trials, Inc. 1997 - 1999
Skills
Data Management, Proposal Writing, RFP
Education
American InterContinental University 2005 — 2006
AA, Business Administration
Synteract, Inc. October 2012 - Present
Quintiles April 2011 - October 2012
Quintiles November 2010 - April 2011
Aerotek May 2010 - November 2010
Clinimetrics Research Associates 2004 - 2009
Clinimetrics 2001 - 2004
Ingenix 1999 - 2001
Worldwide Clinical Trials, Inc. 1997 - 1999
Skills
Data Management, Proposal Writing, RFP
Education
American InterContinental University 2005 — 2006
AA, Business Administration
Sang Le, PMP's Clinimetrics Research Associates Experience 2000 - 2005
Job VP Clinical Operations at New Haven Pharmaceuticals, Inc.
Industry Pharmaceuticals
Experience
New Haven Pharmaceuticals, Inc. November 2014 - Present
Quintiles October 2014 - November 2014
Quintiles August 2012 - October 2014
InVasc Therapeutics September 2011 - July 2012
Shionogi Pharma (formerly Sciele Pharma) October 2006 - June 2011
Altea Therapeutics May 2005 - October 2006
Clinimetrics Research Associates 2000 - 2005
Emory University School of Medicine 1992 - 1999
Emory Healthcare 1986 - 1991
Skills
CRO, Dermatology, Biotechnology, Diabetes, Rheumatology, Osteoporosis, Clinical Research, Clinical Trials, Clinical, Pediatrics, Therapeutic areas, Pharmaceuticals, EDC, Clinical Trial..., Cardiology, Endocrinology, Clinical Development, SOP, Medical Devices, Regulatory Submissions, GCP, Strategic Planning, Neurology, Medical Writing, Budgeting, Cross-functional Team..., Team Leadership, Protocol Development, IND, Process Improvement, Team Building, Pharmaceutical Industry, CTMS, Sop, Budgets, FDA, Lifesciences, Therapeutic Areas, Pharmacovigilance, Clinical Study Design, Oncology, Drug Development, Clinical Monitoring, Infectious Diseases, Pharmaceutics, ICH-GCP, Protocol, Clinical Operations, Life Sciences
Education
Tulane University - A.B. Freeman School of Business
MBA Certificate in Business Administration
Emory University 1994 — 1996
Business Administration
Truòng Dai hoc y Duoc Hô Chí Minh 1985 — 1985
Medicine
Truòng Dai hoc y Duoc Hô Chí Minh 1980 — 1984
BSc., Medicine
New Haven Pharmaceuticals, Inc. November 2014 - Present
Quintiles October 2014 - November 2014
Quintiles August 2012 - October 2014
InVasc Therapeutics September 2011 - July 2012
Shionogi Pharma (formerly Sciele Pharma) October 2006 - June 2011
Altea Therapeutics May 2005 - October 2006
Clinimetrics Research Associates 2000 - 2005
Emory University School of Medicine 1992 - 1999
Emory Healthcare 1986 - 1991
Skills
CRO, Dermatology, Biotechnology, Diabetes, Rheumatology, Osteoporosis, Clinical Research, Clinical Trials, Clinical, Pediatrics, Therapeutic areas, Pharmaceuticals, EDC, Clinical Trial..., Cardiology, Endocrinology, Clinical Development, SOP, Medical Devices, Regulatory Submissions, GCP, Strategic Planning, Neurology, Medical Writing, Budgeting, Cross-functional Team..., Team Leadership, Protocol Development, IND, Process Improvement, Team Building, Pharmaceutical Industry, CTMS, Sop, Budgets, FDA, Lifesciences, Therapeutic Areas, Pharmacovigilance, Clinical Study Design, Oncology, Drug Development, Clinical Monitoring, Infectious Diseases, Pharmaceutics, ICH-GCP, Protocol, Clinical Operations, Life Sciences
Education
Tulane University - A.B. Freeman School of Business
MBA Certificate in Business Administration
Emory University 1994 — 1996
Business Administration
Truòng Dai hoc y Duoc Hô Chí Minh 1985 — 1985
Medicine
Truòng Dai hoc y Duoc Hô Chí Minh 1980 — 1984
BSc., Medicine
Diana Chung Diana Chung's Clinimetrics Research Associates Experience October 2001 - June 2004
Job Director, Clinical Operations at Gilead Sciences
Industry Biotechnology
Experience
Gilead Sciences February 2014 - Present
Gilead Sciences December 2011 - January 2014
Theravance June 2011 - December 2011
Genentech January 2010 - May 2011
Roche Palo Alto May 2008 - January 2010
ARYx Therapeutics June 2007 - April 2008
XenoPort January 2006 - May 2007
XenoPort July 2004 - December 2005
Clinimetrics Research Associates October 2001 - June 2004
Scios Inc July 2000 - October 2001
Skills
Clinical Trials, Neuropathic Pain, Patient Recruitment, Phase I, Outsourcing, NDA, IND, EDC, Protocol, Oncology, CRO, Clinical Development, Clinical Research, Clinical Data Management, Neurology, Drug Discovery, Regulatory Affairs, Clinical Pharmacology, Sop, SOP
Education
University of Maryland Baltimore 1992 — 1995
MS, Molecular & Cell Biology
Case Western Reserve University 1987 — 1991
BS, Biochemistry
Gilead Sciences February 2014 - Present
Gilead Sciences December 2011 - January 2014
Theravance June 2011 - December 2011
Genentech January 2010 - May 2011
Roche Palo Alto May 2008 - January 2010
ARYx Therapeutics June 2007 - April 2008
XenoPort January 2006 - May 2007
XenoPort July 2004 - December 2005
Clinimetrics Research Associates October 2001 - June 2004
Scios Inc July 2000 - October 2001
Skills
Clinical Trials, Neuropathic Pain, Patient Recruitment, Phase I, Outsourcing, NDA, IND, EDC, Protocol, Oncology, CRO, Clinical Development, Clinical Research, Clinical Data Management, Neurology, Drug Discovery, Regulatory Affairs, Clinical Pharmacology, Sop, SOP
Education
University of Maryland Baltimore 1992 — 1995
MS, Molecular & Cell Biology
Case Western Reserve University 1987 — 1991
BS, Biochemistry
Lynda Jo Nordstrom, RN, BSN, MA Lynda Jo Nordstrom, RN, BSN, MA's Clinimetrics Research Associates Experience September 2008 - November 2009
Job LN Clinical Research and Wellness LLC
Industry Health, Wellness and Fitness
Experience
Tactile Medical February 2010 - May 2014
Clinimetrics Research Associates September 2008 - November 2009
Clinimetrics Research Associates September 2003 - May 2008
Clinimetrics Research Associates January 1999 - January 2008
Mayo Clinic May 2002 - July 2003
Mayo Clinic January 1989 - January 1999
Mayo Clinic June 1981 - June 1989
Skills
Neurology, Dermatology, Endocrinology, Transplant, CTMS, Nephrology, Clinical Trials, Pharmaceutical Industry, Clinical Monitoring, GCP, Sop, Clinical Data Management, Biotechnology, Pharmacovigilance, Therapeutic Areas, EDC, Quality Assurance, Medical Writing, Phase I, Training, Medical Devices, FDA, Cardiology, Regulatory Submissions, 21 CFR Part 11, Clinical Research, CRF design, Protocol, Clinical Study Design, Rheumatology, Inform, Clinical Operations, Oracle Clinical, Vaccines, Hematology, Cardiovascular Disease, ICH-GCP, CRO, Medical Affairs, Nursing, Oncology, Infectious Diseases, Patient Recruitment, Drug Development, Clinical Development, IRB, Diabetes, Software Documentation, Regulatory Affairs, Clinical Research...
Education
Wisdom of the Whole, Bark Coaching Institute 2015 — 2015
Holistic Health
Saint Mary's University of Minnesota 1989 — 1991
Masters Degree, Human and Health Services Administration
Viterbo University 1977 — 1981
Bachelor's Degree, Nursing
Tactile Medical February 2010 - May 2014
Clinimetrics Research Associates September 2008 - November 2009
Clinimetrics Research Associates September 2003 - May 2008
Clinimetrics Research Associates January 1999 - January 2008
Mayo Clinic May 2002 - July 2003
Mayo Clinic January 1989 - January 1999
Mayo Clinic June 1981 - June 1989
Skills
Neurology, Dermatology, Endocrinology, Transplant, CTMS, Nephrology, Clinical Trials, Pharmaceutical Industry, Clinical Monitoring, GCP, Sop, Clinical Data Management, Biotechnology, Pharmacovigilance, Therapeutic Areas, EDC, Quality Assurance, Medical Writing, Phase I, Training, Medical Devices, FDA, Cardiology, Regulatory Submissions, 21 CFR Part 11, Clinical Research, CRF design, Protocol, Clinical Study Design, Rheumatology, Inform, Clinical Operations, Oracle Clinical, Vaccines, Hematology, Cardiovascular Disease, ICH-GCP, CRO, Medical Affairs, Nursing, Oncology, Infectious Diseases, Patient Recruitment, Drug Development, Clinical Development, IRB, Diabetes, Software Documentation, Regulatory Affairs, Clinical Research...
Education
Wisdom of the Whole, Bark Coaching Institute 2015 — 2015
Holistic Health
Saint Mary's University of Minnesota 1989 — 1991
Masters Degree, Human and Health Services Administration
Viterbo University 1977 — 1981
Bachelor's Degree, Nursing
Sarah Mullen's Clinimetrics Research Associates Experience 2004 - 2004
Job Director, Clinical Operations at Carbylan Therapeutics
Industry Medical Devices
Experience
Carbylan Therapeutics September 2015 - Present
Carbylan May 2014 - September 2015
Spiracur, Inc. June 2011 - April 2014
Spiracur June 2009 - June 2011
ev3, FoxHollow Division October 2007 - November 2008
FoxHollow Technologies August 2006 - October 2007
Elan Pharmaceuticals July 2005 - August 2006
The Cardiovascular Institute January 2005 - July 2005
BioScience Incubator December 2004 - February 2005
Clinimetrics Research Associates 2004 - 2004
Skills
Biotechnology, Healthcare, FDA, Clinical Research, Medical Devices, Clinical Development, Pharmaceutical Industry, CTMS, Cardiology, Clinical Trials
Education
San Jose State University 2003 — 2005
MBT, Biotechnology
Colorado College 1999 — 2002
Bachelors, Neuroscience
LGHS
Carbylan Therapeutics September 2015 - Present
Carbylan May 2014 - September 2015
Spiracur, Inc. June 2011 - April 2014
Spiracur June 2009 - June 2011
ev3, FoxHollow Division October 2007 - November 2008
FoxHollow Technologies August 2006 - October 2007
Elan Pharmaceuticals July 2005 - August 2006
The Cardiovascular Institute January 2005 - July 2005
BioScience Incubator December 2004 - February 2005
Clinimetrics Research Associates 2004 - 2004
Skills
Biotechnology, Healthcare, FDA, Clinical Research, Medical Devices, Clinical Development, Pharmaceutical Industry, CTMS, Cardiology, Clinical Trials
Education
San Jose State University 2003 — 2005
MBT, Biotechnology
Colorado College 1999 — 2002
Bachelors, Neuroscience
LGHS
Eric Marston's Clinimetrics Research Associates Experience August 2004 - October 2008
Job
Industry Pharmaceuticals
Experience
Immucor, Inc. April 2014 - Present
Shaw Science Partners October 2010 - April 2014
Kimberly-Clark October 2008 - October 2010
Clinimetrics Research Associates August 2004 - October 2008
Merial Ltd September 2001 - August 2004
Centers for Disease Control January 1994 - September 2001
University of Alabama August 1993 - December 1994
Skills
Clinical Research, Clinical Trials, Clinical Trial..., Project Portfolio..., Research Project..., Multimedia Project..., Medical Devices, Medical Device Product..., Phase I, Phase II, Phase III, Operations Management, Science Communication, Science Education, R&D, Site Selection, Supplier Negotiations, Budget Development, Clinical Data Management, clinical, Pharmaceutical Industry, Biosimilars, EDC, CTMS, GCPs, FDA GMP, GLP, GxP, Animation, Video Production, Science, Vaccines, Kidney Transplant, Liver Transplant, Oncology Clinical..., Rheumatology, MS Project, Project Management, Supplier Negotiation, Location Intelligence, Multimedia, Cross-functional Team..., Oncology, Biotechnology, Clinical Research..., Medical Writing, Drug Development, Infectious Diseases, Molecular Biology, Clinical Development
Education
Auburn University
Bachelor's degree
The University of Georgia
Master of Science (MSc)
University of Alabama at Birmingham
Master of Public Health (MPH)
Immucor, Inc. April 2014 - Present
Shaw Science Partners October 2010 - April 2014
Kimberly-Clark October 2008 - October 2010
Clinimetrics Research Associates August 2004 - October 2008
Merial Ltd September 2001 - August 2004
Centers for Disease Control January 1994 - September 2001
University of Alabama August 1993 - December 1994
Skills
Clinical Research, Clinical Trials, Clinical Trial..., Project Portfolio..., Research Project..., Multimedia Project..., Medical Devices, Medical Device Product..., Phase I, Phase II, Phase III, Operations Management, Science Communication, Science Education, R&D, Site Selection, Supplier Negotiations, Budget Development, Clinical Data Management, clinical, Pharmaceutical Industry, Biosimilars, EDC, CTMS, GCPs, FDA GMP, GLP, GxP, Animation, Video Production, Science, Vaccines, Kidney Transplant, Liver Transplant, Oncology Clinical..., Rheumatology, MS Project, Project Management, Supplier Negotiation, Location Intelligence, Multimedia, Cross-functional Team..., Oncology, Biotechnology, Clinical Research..., Medical Writing, Drug Development, Infectious Diseases, Molecular Biology, Clinical Development
Education
Auburn University
Bachelor's degree
The University of Georgia
Master of Science (MSc)
University of Alabama at Birmingham
Master of Public Health (MPH)
Brian Olender's Clinimetrics Research Associates Experience February 2005 - October 2005
Job Associate Director, EDC Programming at Gilead Sciences
Industry Biotechnology
Experience
Gilead Sciences November 2010 - Present
Abbott Vascular February 2010 - November 2010
Abbott Vascular July 2007 - January 2010
Guidant Corp./ Abbott Vascular March 2006 - June 2007
Guidant Corporation October 2005 - March 2006
Clinimetrics Research Associates February 2005 - October 2005
Clinimetrics Research Associates March 2003 - February 2005
Aviron / MedImmune Vaccines August 2001 - February 2003
Roche Pharmaceuticals September 2000 - July 2001
Robert Half International March 1999 - September 2000
Skills
Clinical Data Management, EDC, CTMS, Biotechnology, Medical Devices, Clinical Trials, 21 CFR Part 11, GCP, CRO, Clinical Development, Pharmaceutical Industry, FDA, Clinical Research, Data Management, Sop, Validation, Inform, Oncology, Computer System..., Clinical Operations, CRF design, Quality System, Software Documentation, Oracle Clinical, Clinical Study Design, SDLC, CDISC, Change Control, CAPA, Pharmaceutics, Biopharmaceuticals, Regulatory Requirements, Clinical Monitoring, Vaccines, Lifesciences, Regulatory Affairs, ICH-GCP, Pharmacovigilance, Protocol, Regulatory Submissions, Therapeutic Areas, Life Sciences
Education
Whitman College 1994 — 1997
Bachelor of Arts (B.A.), History
University of California, Los Angeles 1992 — 1993
Gilead Sciences November 2010 - Present
Abbott Vascular February 2010 - November 2010
Abbott Vascular July 2007 - January 2010
Guidant Corp./ Abbott Vascular March 2006 - June 2007
Guidant Corporation October 2005 - March 2006
Clinimetrics Research Associates February 2005 - October 2005
Clinimetrics Research Associates March 2003 - February 2005
Aviron / MedImmune Vaccines August 2001 - February 2003
Roche Pharmaceuticals September 2000 - July 2001
Robert Half International March 1999 - September 2000
Skills
Clinical Data Management, EDC, CTMS, Biotechnology, Medical Devices, Clinical Trials, 21 CFR Part 11, GCP, CRO, Clinical Development, Pharmaceutical Industry, FDA, Clinical Research, Data Management, Sop, Validation, Inform, Oncology, Computer System..., Clinical Operations, CRF design, Quality System, Software Documentation, Oracle Clinical, Clinical Study Design, SDLC, CDISC, Change Control, CAPA, Pharmaceutics, Biopharmaceuticals, Regulatory Requirements, Clinical Monitoring, Vaccines, Lifesciences, Regulatory Affairs, ICH-GCP, Pharmacovigilance, Protocol, Regulatory Submissions, Therapeutic Areas, Life Sciences
Education
Whitman College 1994 — 1997
Bachelor of Arts (B.A.), History
University of California, Los Angeles 1992 — 1993
Jayne Dito's Clinimetrics Research Associates Experience 2002 - 2005
Job at Jayne M Dito Consulting
Industry Pharmaceuticals
Experience
Jayne M Dito Consulting January 2006 - Present
Clinimetrics 2002 - 2005
Clinimetrics Research 2002 - 2005
Clinimetrics Research 2002 - 2005
Clinimetrics Research Associates 2002 - 2005
Matrix Pharmaceutical 1988 - 1999
Matrix Pharmaceuticals 1988 - 1999
Education
University of San Francisco 1952 — 1958
Jayne M Dito Consulting January 2006 - Present
Clinimetrics 2002 - 2005
Clinimetrics Research 2002 - 2005
Clinimetrics Research 2002 - 2005
Clinimetrics Research Associates 2002 - 2005
Matrix Pharmaceutical 1988 - 1999
Matrix Pharmaceuticals 1988 - 1999
Education
University of San Francisco 1952 — 1958
Tania Johnstone Issa's Clinimetrics Research Associates Experience 1994 - 1999
Job Consultant in Clinical Trials Operations, Technologies & Compliance
Industry Biotechnology
Experience
Seattle WA, Self Employed August 2008 - Present
Insite QA (formerly cGXP Consultants) April 2008 - Present
Spacelabs Healthcare, a Subsidiary of OSI Systems February 2005 - February 2008
Independent Consulting 2000 - 2005
Clinimetrics Research Associates 1994 - 1999
Chiron Corporation [Now Novartis] 1994 - 1996
IBRD [Now MDS Pharma] 1993 - 1994
Los Angeles County Department of Health and Human Services 1989 - 1993
Skills
Clinical Trials, Medical Devices, CRO, Strategy, Vendor Management, Start-ups, GCP, Pharmaceutical Industry, Clinical Research, Business Development, Project Management, Forecasting, Mergers, Competitive Analysis, Protocol, Medical Writing, Recruiting, Financial Analysis, Data Management, FDA, Mergers & Acquisitions, Clinical Development, CTMS, Leadership
Education
California State University-Long Beach 1987 — 1991
Bachelor of Science, Health Sciences, Health Education
California State University-Long Beach 1987 — 1991
Bachelor of Science (BS), Health Services/Allied Health/Health Sciences, General
Seattle WA, Self Employed August 2008 - Present
Insite QA (formerly cGXP Consultants) April 2008 - Present
Spacelabs Healthcare, a Subsidiary of OSI Systems February 2005 - February 2008
Independent Consulting 2000 - 2005
Clinimetrics Research Associates 1994 - 1999
Chiron Corporation [Now Novartis] 1994 - 1996
IBRD [Now MDS Pharma] 1993 - 1994
Los Angeles County Department of Health and Human Services 1989 - 1993
Skills
Clinical Trials, Medical Devices, CRO, Strategy, Vendor Management, Start-ups, GCP, Pharmaceutical Industry, Clinical Research, Business Development, Project Management, Forecasting, Mergers, Competitive Analysis, Protocol, Medical Writing, Recruiting, Financial Analysis, Data Management, FDA, Mergers & Acquisitions, Clinical Development, CTMS, Leadership
Education
California State University-Long Beach 1987 — 1991
Bachelor of Science, Health Sciences, Health Education
California State University-Long Beach 1987 — 1991
Bachelor of Science (BS), Health Services/Allied Health/Health Sciences, General
Leslie O'Toole's Clinimetrics Research Associates Experience November 2008 - November 2009
Job Director, Clinical Research at inVentiv Health Clinical
Industry Research
Experience
InVentiv Health August 2013 - Present
Tolera Therapeutics, Inc. November 2009 - July 2013
Clinimetrics Research Associates November 2008 - November 2009
Clinimetrics Research Associates November 2006 - October 2008
Clinimetrics Research Associates October 1998 - October 2006
Clinimetrics Research Associates August 1994 - October 1998
Skills
CTMS, GCP, Clinical Data Management, Clinical Trials, Medical Devices, FDA, Rheumatology, Project Management, Infectious Diseases, Pharmaceutical Industry, Pharmacovigilance, Clinical Development, Diabetes, ICH-GCP, CRO, Drug Development, Protocol, Clinical Study Design, Biotechnology, Oncology, Lifesciences, 21 CFR Part 11, EDC, Clinical Research, Clinical Monitoring, Therapeutic Areas, Clinical Operations, Immunology, Regulatory Submissions, Medical Writing, Sop
Education
University of Pittsburgh 1984 — 1988
BSN, Nursing
InVentiv Health August 2013 - Present
Tolera Therapeutics, Inc. November 2009 - July 2013
Clinimetrics Research Associates November 2008 - November 2009
Clinimetrics Research Associates November 2006 - October 2008
Clinimetrics Research Associates October 1998 - October 2006
Clinimetrics Research Associates August 1994 - October 1998
Skills
CTMS, GCP, Clinical Data Management, Clinical Trials, Medical Devices, FDA, Rheumatology, Project Management, Infectious Diseases, Pharmaceutical Industry, Pharmacovigilance, Clinical Development, Diabetes, ICH-GCP, CRO, Drug Development, Protocol, Clinical Study Design, Biotechnology, Oncology, Lifesciences, 21 CFR Part 11, EDC, Clinical Research, Clinical Monitoring, Therapeutic Areas, Clinical Operations, Immunology, Regulatory Submissions, Medical Writing, Sop
Education
University of Pittsburgh 1984 — 1988
BSN, Nursing
Sandy Fournier's Clinimetrics Research Associates Experience December 1993 - April 2010
Job CRA Manager at PAREXEL
Industry Biotechnology
Experience
PAREXEL August 2014 - Present
SF Consulting October 2013 - August 2014
ProTrials April 2013 - October 2013
ReSearch Pharmaceutical Services April 2011 - April 2013
Sandra Fournier May 2010 - April 2011
Clinimetrics Research Associates December 1993 - April 2010
Sonoma Valley Hospital Home Care 1989 - 1993
Syntex USA Palo Alto, CA 1986 - 1989
Skills
CTMS, Clinical Trials, GCP, Clinical Development, CRO, EDC, Neurology, Pharmaceutical Industry, Clinical Data Management, Clinical Research, Infectious Diseases, Biotechnology, Diabetes, Clinical Operations, Oncology
Education
San Diego State University-California State University 1972 — 1977
BSN, Nursing
PAREXEL August 2014 - Present
SF Consulting October 2013 - August 2014
ProTrials April 2013 - October 2013
ReSearch Pharmaceutical Services April 2011 - April 2013
Sandra Fournier May 2010 - April 2011
Clinimetrics Research Associates December 1993 - April 2010
Sonoma Valley Hospital Home Care 1989 - 1993
Syntex USA Palo Alto, CA 1986 - 1989
Skills
CTMS, Clinical Trials, GCP, Clinical Development, CRO, EDC, Neurology, Pharmaceutical Industry, Clinical Data Management, Clinical Research, Infectious Diseases, Biotechnology, Diabetes, Clinical Operations, Oncology
Education
San Diego State University-California State University 1972 — 1977
BSN, Nursing
Cheryl Hambrock's Clinimetrics Research Associates Experience 2005 - November 2011
Job Clinical Research Consultant at ProTrials Research, Inc.
Industry Research
Experience
ProTrials Research July 2012 - Present
ReSearch Pharmaceutical Services November 2011 - July 2012
Clinimetrics Research Associates 2005 - November 2011
Omnicare Clinical Research 2005 - November 2011
Education
Bloomfield College
BA, Nursing
Mercer County Community College
Certificate, Clinical Reseach
ProTrials Research July 2012 - Present
ReSearch Pharmaceutical Services November 2011 - July 2012
Clinimetrics Research Associates 2005 - November 2011
Omnicare Clinical Research 2005 - November 2011
Education
Bloomfield College
BA, Nursing
Mercer County Community College
Certificate, Clinical Reseach
Barbara von der Groeben, RN, MS's Clinimetrics Research Associates Experience 2000 - 2001
Job Independent Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
von der Groeben Consulting, LLC 2011 - Present
Affymax, Inc. 2008 - 2011
Genentech 2001 - 2007
Clinimetrics 2000 - 2001
Clinimetrics Research Associates 2000 - 2001
ALZA Corporation 1996 - 2000
Syntex 1988 - 1995
Skills
Clinical QA, GCP, Clinical Trials, Quality Assurance, Clinical Research, Regulatory Affairs, Oncology, Clinical Development, GLP, FDA, Biotechnology, 21 CFR Part 11, CRO, Drug Development, Infectious Diseases
Education
UCSF 1982 — 1984
MS, Cardiovascular Nursing, Medical
Skidmore College
BS, Nursing
von der Groeben Consulting, LLC 2011 - Present
Affymax, Inc. 2008 - 2011
Genentech 2001 - 2007
Clinimetrics 2000 - 2001
Clinimetrics Research Associates 2000 - 2001
ALZA Corporation 1996 - 2000
Syntex 1988 - 1995
Skills
Clinical QA, GCP, Clinical Trials, Quality Assurance, Clinical Research, Regulatory Affairs, Oncology, Clinical Development, GLP, FDA, Biotechnology, 21 CFR Part 11, CRO, Drug Development, Infectious Diseases
Education
UCSF 1982 — 1984
MS, Cardiovascular Nursing, Medical
Skidmore College
BS, Nursing
Stephen DiLeo's Clinimetrics Research Associates Experience January 2004 - April 2010
Job President, Advanced Clinical Services, Inc
Industry Research
Experience
Advanced Clinical Services, Inc. April 2010 - Present
Advanced Clinical Services, LLC February 2013 - June 2014
Clinimetrics Research Associates January 2004 - April 2010
Clinimetrics Research ASSOCIATES January 1996 - April 2010
Clinimetrics 1996 - 2010
Clinimetrics Research Associates January 2000 - January 2004
Clinimetrics Research Associates January 1996 - January 2000
Tulane University Medical Center January 1994 - January 1996
Telemetry and CCU January 1993 - January 1994
Slidell Memorial Hospital and Medical Center January 1992 - January 1993
Skills
CTMS, Clinical Trials, Clinical Research, Clinical Monitoring, Diabetes, Medical Devices, FDA, Protocol, Data Management, GCP, CRO, Clinical Operations, Endocrinology, EDC, Neurology, Cardiology, Phase I, Medidata, SharePoint, TrialCentralNet, PHT Study Works, INC Research Trial..., IMPACT Standard and..., ELVIS - Quintiles, INC Project Point
Education
University of New Orleans 1986 — 1989
MBA, Business Administration
University of New Orleans
Master’s Degree, Business Administration
Southeastern Louisiana University 1974 — 1977
BSN, Nursing
Southeastern Louisiana University
Bachelors of Science, Nursing
Advanced Clinical Services, Inc. April 2010 - Present
Advanced Clinical Services, LLC February 2013 - June 2014
Clinimetrics Research Associates January 2004 - April 2010
Clinimetrics Research ASSOCIATES January 1996 - April 2010
Clinimetrics 1996 - 2010
Clinimetrics Research Associates January 2000 - January 2004
Clinimetrics Research Associates January 1996 - January 2000
Tulane University Medical Center January 1994 - January 1996
Telemetry and CCU January 1993 - January 1994
Slidell Memorial Hospital and Medical Center January 1992 - January 1993
Skills
CTMS, Clinical Trials, Clinical Research, Clinical Monitoring, Diabetes, Medical Devices, FDA, Protocol, Data Management, GCP, CRO, Clinical Operations, Endocrinology, EDC, Neurology, Cardiology, Phase I, Medidata, SharePoint, TrialCentralNet, PHT Study Works, INC Research Trial..., IMPACT Standard and..., ELVIS - Quintiles, INC Project Point
Education
University of New Orleans 1986 — 1989
MBA, Business Administration
University of New Orleans
Master’s Degree, Business Administration
Southeastern Louisiana University 1974 — 1977
BSN, Nursing
Southeastern Louisiana University
Bachelors of Science, Nursing
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY