INC Research (formerly Kendle International)
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INC Research (formerly Kendle International) Employees
Gilead Sciences via Aerotek Scientific, LLC July 2013 - December 2014
Amgen 2005 - 2012
INC Research (formerly Kendle International) 1999 - 2005
North County Neurology Associates 1995 - 1997
Tri-City Medical Center 1986 - 1995
Skills
GCP, EDC, Therapeutic Areas, Clinical Trials, Clinical Development, Clinical Operations, ICH-GCP, Clinical Research, Biotechnology, CRO, Regulatory Submissions, Drug Safety, Oracle Clinical, Clinical Data Management, Lifesciences, Drug Development, MedDRA, E2B, Argus Safety, SAE Reconciliation, Oncology, Pharmaceutical Industry, CTMS, IND, Protocol, FDA, Clinical Monitoring, Sop, Hematology, 21 CFR Part 11, eCTD, SOP, Regulatory Affairs, Biopharmaceuticals
Education
University of San Diego
Bachelors of science in nursing, Nursing
Riverside White-Cross School of Nursing
RN, Registered Nursing/Registered Nurse
INC Research (formerly Kendle International) November 2008 - Present
Schulman Associates IRB January 2007 - August 2008
Cincinnati Children's Hospital Medical Center August 1997 - February 2002
Skills
Pharmaceutical Industry, Clinical Trials, CRO, Sop, CTMS, Clinical Development, Clinical Research, ICH-GCP, FDA
Education
Youngstown State University 1984 — 1987
Bachelor of Applied Science (BASc), Nutrition Sciences
University of Cincinnati
Master of Education (MEd), Health and Wellness, General
PPD July 2012 - Present
INC Research (formerly Kendle International) June 2009 - March 2012
INC Research (formerly Kendle International) October 2008 - June 2009
INC Research (formerly Kendle International) August 2007 - October 2008
INC Research (formerly Kendle International) October 2006 - August 2007
INC Research (formerly Kendle International) July 2005 - October 2006
INC Research (formerly Kendle International) July 2004 - July 2005
Northern Kentucky University July 1998 - July 2004
Skills
Clinical Data Management, Electronic Data Capture..., Global Leadership, Programming, Process Improvement, Training & Development, EDC, Clinical Trials, Oracle Clinical, Employee Training, CRF design, Databases, CRO, Data Management, Protocol, SAS programming, Clinical Research, Software Documentation, GCP
Education
Northern Kentucky University
Masters, Information Systems
Northern Kentucky University
Bachelors, Biological Sciences
Northern Kentucky University
Bachelors, Environmental Sciences
BioClinica April 2014 - Present
BioClinica March 2013 - April 2014
BioClinica September 2012 - March 2013
INC Research (Formerly Kendle International) November 2005 - November 2012
A-R MAZZOTTA EMPLOYMENT SPECIALISTS January 2004 - June 2004
THE PANTRY, INC October 2002 - December 2003
ENERGY UNITED February 2000 - September 2002
Ferrellgas September 1998 - February 2000
WHISPER KNITS, INC. December 1991 - September 1998
Skills
Clinical Trials, Database Management, Data Entry, Ten Key, Data Management, Customer Service, Medical Coding, Coaching, Microsoft Office, Educational Leadership, Database Administration, Product Development, Excel, Event Planning, Lotus Notes, Mentoring, Problem Solving, Teamwork, Team Oriented, Deadline Driven, Meeting Deadlines, Customer Focus, Customer Satisfaction, Attention To Detail, Self Starter, Eye For Detail, Intergrated Review, Oracle Clinical, Clinical Data Management, EDC, OC RDC, Oracle Discoverer, eCRF, CRF design, INET, Data Cleaning, Data Validation, ICH-GCP, Inform, CDISC, MedDRA
Education
New England Institute of Technology 1985 — 1986
Computer Programming
Haddam-Killingworth High School 1980 — 1984
Diploma, College/University Preparatory and Advanced High School/Secondary Diploma Program
INC Research January 2015 - Present
INC Research (Formerly Kendle International) October 2010 - January 2015
Mollen Immunization Clinics August 2010 - January 2013
Kaplan February 2012 - November 2012
Cincinnati Institute of Age Management August 2006 - September 2010
TriHealth-Hospice of Cincinnati 2004 - 2010
HealthSource of Ohio January 2002 - November 2004
Skills
Microsoft Office, Excel, Medisoft, Argus, Medic, Phlebotomy, IV Therapy, Hospice, Pediatrics, Family Practice, Pharmacovigilance, IV, Microsoft Excel, Nursing, Medicine, Family Medicine, Hospitals, Software Documentation, Healthcare, Clinical Research, Patient Safety, Clinical Trials, Patient Education, Nursing Education
Education
Hondros College-School of Nursing 2007 — 2010
RN,AAS, Nursing
University of Cincinnati 1999 — 2003
Associate of Applied Sciences, Allied Health
PAREXEL January 2012 - Present
INC Research (formerly Kendle International) January 2010 - December 2011
Kendle International 2006 - 2010
Charles River Laboratories Clinical Services 2004 - 2006
PharmaResearch Corporation (acquired by Inveresk) 2000 - 2004
Duke University Medical Center 1998 - 2000
University of Miami School of Medicine 1997 - 1998
Skills
Clinical Research, Business Intelligence, Project Management, Analytics, Clinical Trials, Pharmaceutical Industry, CRO, Clinical Development, Strategy, ICH-GCP, Strategic Planning, CTMS, GCP, Biotechnology, Cross-functional Team...
Education
Arizona State University - W. P. Carey School of Business 2008 — 2009
MBA, Business Administration
University of Miami 1993 — 1997
PhD, Health Clinical Psychology
Marquette University 1991 — 1993
MS, Clinical Psychology
Marquette University 1987 — 1991
BA, Psychology
Gemological Institute of America-New York 2009 — 2013
GG, Gemology
Champion Clinical Research Consultants, LLC January 2012 - Present
PAREXEL March 2011 - January 2012
INC Research (Formerly Kendle International) October 2005 - March 2011
Skills
Clinical Monitoring, EDC, CTMS, ICH-GCP, CRO, GCP, Clinical Trials, Therapeutic Areas, Clinical Development, Oncology, Oracle Clinical, Ophthalmology, Rheumatology, Cardiology, Neurology, Diabetic Retinopathy, Macular Degeneration, Orthopedic, Medical Devices, Hematology, Uveitis, Macular Edema, Retinal Vein Occlusion, Retinal Ophthalmology, Pulmonology, Lung Transplantation, Protocol, Regulatory Submissions, Infectious Diseases, Clinical Research, Pharmaceutical Industry, SOP, Drug Development
Education
Lorain County Community College 1997 — 1999
Registered Nursing Program
Southwest General Medical Center 1996 — 1997
NREMT-B, Emergency Medical Technology/Technician (EMT)
Cleveland State University 1995 — 1997
Pre-Medical Studies/Psychology
Great American Financial Resources April 2012 - Present
INC Research (formerly Kendle International) 2007 - April 2012
INC Research (formerly Kendle International) 2004 - 2007
Avanade 2001 - 2004
Whittman-Hart / marchFIRST 1996 - 2001
Ernst & Young 1995 - 1996
Chiquita 1993 - 1995
US Army 1987 - 1990
Skills
Application Architecture, Requirements Analysis, SDLC, Requirements Gathering, Software Development, Software Documentation, IT Strategy, Project Management, Process Improvement, Database Design, Business Process, Software Project..., Data Warehousing, PMO, Management, Databases, Quality Assurance, Testing, VB.NET, Business Intelligence, Leadership, Visual Basic
Education
University of Cincinnati College of Business
Bachelor of Business Administration, Information Systems
University of Cincinnati College of Business
Information Systems
INC Research (formerly Kendle International) March 2007 - Present
INC Research 2007 - Present
National Underground Railroad Freedom Center August 2005 - November 2006
Skills
21 CFR Part 11, SharePoint, GCP, Sop, Software Documentation
Education
Northern Kentucky University 2008 — 2011
BA, Organizational Leadership
Thomas More College 2007 — 2008
Business Administration and Management, General
INC Research December 2014 - Present
INC Research (formerly Kendle International) 2011 - December 2014
Kendle International 2008 - 2011
i3 Statprobe 2006 - 2008
i3 Statprobe 2005 - 2006
PPD January 2003 - July 2004
PPD 1999 - 2002
PPD 1997 - 1999
WakeMed June 1996 - July 1997
PPD 1994 - 1996
Education
North Carolina State University
Bachelor of Arts, English
American Modern Insurance Group May 2014 - Present
INC Research (Formerly Kendle International) October 2008 - May 2014
Kendle International Inc. October 2005 - October 2008
Licensing Financial Services February 2003 - September 2005
Andersen Worldwide 1995 - 1997
Skills
Pharmaceutical Industry, Finance, Internal Audit, Accounting, CRO, Clinical Development, Financial Reporting, Biotechnology, Process Improvement, EDC, Clinical Trials, Financial Analysis, Clinical Monitoring, ICH-GCP, CTMS, GCP
Education
University of Dayton 1990 — 1994
Bachelor of Science (B.S.), Accounting
Elder High School 1987 — 1990
Array Biostatistics November 2014 - Present
INC Research April 2013 - November 2014
INC Research (formerly Kendle International) October 2010 - March 2013
Kendle International December 2007 - October 2010
Kendle International December 2006 - December 2007
Kendle International May 2005 - December 2006
Skills
SAS programming, CDISC, Microsoft Office 2003, Microsoft Office 2007, Adobe, SDTM, Biostatistics, Oracle Clinical, Clinical Trials, Clinical Data Management, EDC, CRO, Statistical Programming, SAS Programming
Education
University of North Carolina at Wilmington 2002 — 2006
Bachelor's of Science, Statistics
Toyota Motor Engineering & Manufacturing, North America, Inc. (via Aerotek) August 2014 - Present
Currently February 2013 - August 2014
INC Research (formerly Kendle International) 2005 - 2012
INC Research (formerly Kendle International) 2001 - 2005
INC Research (formerly Kendle International) 2000 - 2001
INC Research (formerly Kendle International) 1999 - 2000
Skills
Microsoft Excel, Microsoft Word, Costpoint, Lotus Notes, PeopleSoft, Accounting, Account Reconciliation, CRO
Education
College of Mount St. Joseph 1996 — 1998
Bachelor's degree, Business Administration, Management & Marketing
Tiffin University 1994 — 1996
Bachelor's degree, Business Administration/ Management & Marketing
dunnhumby inc. November 2013 - Present
Omnicare Inc. July 2013 - November 2013
Omnicare January 2012 - July 2013
Omnicare September 2011 - January 2012
INC Research (Formerly Kendle International) July 2010 - September 2011
NorthgateArinso (Formerly Convergys) September 2007 - July 2010
The RightThing, Inc. January 2007 - September 2007
Residence Inn Cincinnati Airport June 2006 - January 2007
Commonwealth Hotels September 2006 - December 2006
Skills
Sourcing, Applicant Tracking..., Full-cycle Recruiting, Immigration, Relocation, LinkedIn, SharePoint, Kenexa Brassring, Workbench Certified, Talent Acquisition, Onboarding, Immigration Law, HRIS, Recruiting, Interviews, Performance Management, Human Resources, Leadership, New Hire Orientations, PeopleSoft, Management, Employee Benefits, Training, Hiring, Screening Resumes, Job Descriptions
Education
Northern Kentucky University 2004 — 2006
BS in Organizational Leadership, Major in Human Resources/Minor in Psychology
University of Louisville 2002 — 2004
None, Vocal Music Performance
Lloyd Memorial High School 1998 — 2002
High School Diploma, High School
Greater Cincinnati Northern Kentucky Apartment Association May 2014 - Present
Greater Cincinnati Northern Kentucky Apartment Association August 2012 - May 2014
INC Research (formerly Kendle International) May 2006 - May 2012
Fifth Third Bank October 2005 - May 2006
Fidelity Investments 2000 - 2005
Three Rivers District Health Department 1998 - 2000
Kentucky Higher Education Assistance Authority 1994 - 1998
Kentucky Higher Education Assistance Authority 1989 - 1994
Internal Revenue Service 1988 - 1989
University of Cincinnati 1987 - 1988
Skills
Microsoft Excel, Microsoft Word, PowerPoint, Customer Service, Research, Windows, Outlook, Budget, Public Speaking, Editing, Data Analysis, Interpersonal Skill, Communication Skills, Lotus Notes, Clinical Trials, Academic Advising, Teamwork, Leadership, Management, Coordination, Higher Education, Compliance, Non-profits, Newsletters, Problem Solving, Quality Auditing, Writing, Root Cause Analysis, Contract Management, Conference Coordination, Team Management, Development & delivery..., Budgets, Human Resources, ICH-GCP, GCP, Clinical Research, Oracle Clinical, Nonprofits, Program Management, 21 CFR Part 11, Communication
Education
Eastern Kentucky University 1982 — 1984
Master of Arts, College Student Counseling and Personnel Services
Northern Kentucky University 1972 — 1977
Bachelor of Science, Business Administration
INC Research (formerly Kendle International) August 2009 - May 2012
Kendle International October 2007 - August 2009
Kilbourne Medical Laboratory June 2007 - October 2007
Procter & Gamble 1978 - 1991
Skills
Clinical Data Management, Clinical Research, Clinical Trials, EDC, Oracle Clinical, GCP, CRF design, ICH-GCP, Clinical Monitoring, Quality Auditing, Electronic Data..., Data Quality, Project Management, Quality Assurance, Regulatory Submissions, Regulatory Requirements, Microbiology, Quality Control, Budgets, Site Management, Document Management, Document Review, site enrollment, Database Queries, High Organizational..., Strong written and..., Close Attention to..., Maintaining Strong..., Build Strong...
Education
University of Cincinnati 1984 — 1986
Associate of Arts (A.A.), Natural Sciences
University of Cincinnati
Courses for Professional Certificate, Clinical Research
Quintiles January 2015 - Present
Quintiles January 2012 - Present
INC Research (Formerly Kendle International) October 2010 - January 2012
Kendle International February 2009 - November 2010
Kendle International June 2007 - January 2009
Kendle International November 2006 - July 2007
Kendle International October 2003 - November 2006
Kendle International April 2002 - October 2003
Kendle International October 2000 - April 2002
Kendle International June 1999 - October 2000
Skills
Infectious Diseases, Oncology, Business Development, Strategy, CRO, Strategic Partnerships, Clinical Data Management, Clinical Development, CRM, Contract Negotiation, GCP, New Business Development, Therapeutic Areas, Clinical Trials, Sales Operations, Leadership, Pharmaceutical Industry, Clinical Research, CTMS, Management, Start-ups, Diabetes, EDC, ICH-GCP, Strategic Planning, Proposal Writing, Budgets, Cardiology, Biopharmaceuticals
Education
Northern Kentucky University 1999 — 2002
RN, BSN, MBA
Amylin Pharmaceuticals, a subsidiary of AstraZeneca June 2012 - Present
INC Research (formerly Kendle International) December 2010 - June 2012
Boehringer Ingelheim March 2009 - January 2011
Pfizer March 2006 - February 2009
sanofi-aventis 2001 - 2006
Watson Pharmaceuticals 1994 - 1999
Duramed Pharmaceuticals 1993 - 1994
Marion Merrel Dow 1987 - 1993
Skills
Regulatory Affairs, Pharmaceutical Industry, Biotechnology, GMP, Quality Assurance, Change Control, 21 CFR Part 11, Regulatory Submissions, FDA, CMC, NDA, CMC Regulatory Affairs, CTD, Validation, Regulatory Strategy..., Product Lifecycle..., SOP, CAPA, Clinical Trials, GxP, New Drug Applications, European Markets, Laboratory, Quality System, German, German to English, EMA, NDA supplements, MAA Variations
Education
University of Cincinnati
inVentiv Health Clinical July 2012 - Present
INC Research (formerly Kendle International) August 2009 - June 2012
Kendle International March 2008 - August 2009
Kendle International October 2006 - March 2008
Kendle International December 2005 - October 2006
Cincinnati Addiction Research Center 2001 - 2005
Cincinnati Addiction Research Center 1999 - 2001
Cincinnati Addiction Research Center 1997 - 1999
Skills
Clinical Data Management, Data Management, Clinical Data, Clinical Trials, EDC, CRO
Education
Northern Kentucky University 2003 — 2004
MS, Information Systems
University of Virginia 1995 — 1997
BA, Biology
PAREXEL July 2012 - Present
INC Research (formerly Kendle International) April 2010 - June 2012
Kendle International April 2007 - April 2010
Kendle International August 2006 - April 2007
Kendle International February 2006 - August 2006
Kendle International April 2005 - February 2006
Kendle International January 2003 - April 2005
Paycor September 2002 - January 2003
Education
University of Cincinnati 1997 — 2002
Bachelor, Marketing
INC Research January 2014 - Present
INC Research January 2012 - December 2013
INC Research (formerly Kendle International) September 2011 - December 2011
INC Research (formerly Kendle International) September 2009 - September 2011
Kendle International May 2006 - September 2009
Shire Pharmaceuticals August 2004 - March 2006
PRA International February 2003 - August 2004
AstraZeneca February 2002 - February 2003
Merck July 2000 - February 2002
Merck June 1998 - July 2000
Skills
Pharmacovigilance, Therapeutic Areas, Clinical Research, Medicine, GCP, Clinical Trials, Clinical Monitoring, CRO, CTMS, Clinical Development, Oncology, Clinical Data Management, ICH-GCP, Clinical Operations, Regulatory Submissions
Education
La Salle University 1993 — 1997
BSN, Nursing
INC Research (formerly Kendle International) October 2008 - Present
Kendle International October 2007 - October 2008
Kendle International February 2005 - October 2007
Kendle International March 2004 - February 2005
Deluxe Corporation August 1986 - December 2003
Skills
Software Documentation, Sop, Training, Leadership, Regulatory Affairs, SOP, FDA, Pharmaceutical Industry, Clinical Development
Education
University of Cincinnati 1996 — 2004
Associate of Applied Business, Business Administration
INC Research (formerly Kendle International) July 2011 - Present
Kendle International July 2006 - July 2011
US Data Management 2005 - 2006
dynport vaccine company 2001 - 2003
Skills
Computer System..., 21 CFR Part 11, GAMP, FDA, Validations, GCP, QC, Validation, SOP, CTMS, CAPA, Quality Assurance, Regulatory Requirements, GxP, Sop, Software Documentation, User Acceptance Testing, Testing, Quality Control, Quality System, Software Quality..., Test Planning, Quality Management, V&V, GMP, Cross-functional Team..., Regulatory Affairs, CRO, Clinical Trials, Process Improvement, Pharmaceutical Industry, Biotechnology, Document Management, Documentation, Leadership
Education
Dowling College 1981 — 1983
Bachelor of Arts (BA), English Language and Literature, General
INC Research (Formerly Kendle International) October 2012 - Present
Kendle International March 2007 - October 2012
Body Scan International January 1997 - December 2006
Education
California School of Professional Psychology - CSPP 1995 — 2003
PhD, Clinical Psychology
University of Colorado Boulder
self-employed September 2008 - Present
INC Research (formerly Kendle International) 2011 - August 2014
i3 Statprobe August 2005 - August 2008
The Write Solution January 2000 - December 2003
Skills
Clinical Development, FDA, Medical Writing, Pharmaceutical Industry, Neurology, Oncology, Clinical Trials, Dermatology, Infectious Diseases, Immunology, Gastroenterology, Endocrinology, CRO, GCP, Clinical Research, Biotechnology, Regulatory Submissions, Life Sciences, ICH-GCP, Drug Development, CTMS, Therapeutic Areas, Regulatory Affairs, Direct Patient Care, Management
Education
Duke University School of Medicine
Physician Assistant, medicine
The University of Connecticut School of Medicine
M.Sc. (incomplete), Community Medicine
Bucknell University
Bachelor's degree, Psychology (experimental)
INC Research (Formerly Kendle International) November 2010 - March 2012
Kendle International December 2009 - November 2010
Kendle International March 2008 - December 2009
Education
Wake Technical Community College 2003 — 2004
Associate of Applied Science, Pharmaceutical Manufacturing
North Carolina State University
Master of Science, Textile Manufacturing
North Carolina State University
Bachelor of Art, Business Administration
Fashion Lyfe, LLC June 2015 - Present
Anonymous November 2013 - Present
INC Research (formerly Kendle International) May 2008 - November 2013
Cato Research January 2007 - April 2008
Skills
Clinical Trials, Forecasting, Variance Analysis, Pharmaceutical Industry, CRO, Clinical Development, Clinical Research, EDC, Oncology, GCP, Microsoft Excel
Education
North Carolina State University
BS/BA, Accounting/Political Science
Rutgers Business School
Master's Degree, Accounting
Cincinnati Children's Hospital Medical Center February 2014 - Present
Cincinnati Children's Hospital Medical Center November 2012 - February 2014
INC Research (formerly Kendle International) April 2006 - 2012
Kendle International February 1996 - March 2006
Procter & Gamble November 1993 - February 1996
Skills
Medidata, CRF design, EDC, Inform, Clinical Trials, CRO, CTMS, GCP, ICH-GCP, Data Validation, OC RDC, Data Management, Clinical Research, Clinical Data Management
Education
Sinclair Community College
University of Cincinnati-Raymond Walters College
MMS Holdings Inc. August 2013 - February 2014
Aastrom Biosciences February 2011 - August 2013
Scientific Consulting, Inc. 2009 - 2011
INC Research (Formerly Kendle International) 2007 - 2009
CDI Corporation (Consultant to Pfizer, Inc.) 2005 - 2007
CCE Consulting Services, Inc. 2003 - 2005
Pfizer 2002 - 2003
Pfizer 1999 - 2002
Pfizer (Formerly Warner Lambert/Parke-Davis) 1995 - 1999
Pfizer (Formerly Warner Lambert/Parke-Davis) 1989 - 1995
Skills
CTMS, GCP, Clinical Monitoring, Oncology, Technology Transfer, Validation, Lifesciences
Education
Eastern Michigan University 1984 — 1989
Bachelor of Science (BS), Health/Health Care Administration/Management