ClinTrials Research Inc,
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ClinTrials Research Inc, Employees
Employee
Years
Job
Industry
Dean Jones PH.D Dean Jones PH.D's ClinTrials Research Inc, Experience 1995 - 1998
Job Therapeutic Team Director at Novartis Pharmaceuticals
Industry Pharmaceuticals
Experience
Novartis Pharmaceuticals June 2010 - Present
Amgen 2006 - 2010
Sanofi-Aventis Pharmaceuticals 2003 - 2006
Eli Lilly & Company Pharmaceuticals 1998 - 2003
ClinTrials Research, Inc 1995 - 1998
Carolina Clinic 1992 - 1995
Skills
Cardiology, Clinical Research, Medicine, CTMS, Neuroscience, Medical Affairs, Diabetes, Clinical Trials, Clinical Development, Osteoporosis, Oncology
Education
La Salle University
Ph.D., Healthcare Research
Logan University
Doctorate, Clinical Sciences
Martin Junior High
Martin Junior High
North Carolina State University
B.S., Pre-Medicine
Novartis Pharmaceuticals June 2010 - Present
Amgen 2006 - 2010
Sanofi-Aventis Pharmaceuticals 2003 - 2006
Eli Lilly & Company Pharmaceuticals 1998 - 2003
ClinTrials Research, Inc 1995 - 1998
Carolina Clinic 1992 - 1995
Skills
Cardiology, Clinical Research, Medicine, CTMS, Neuroscience, Medical Affairs, Diabetes, Clinical Trials, Clinical Development, Osteoporosis, Oncology
Education
La Salle University
Ph.D., Healthcare Research
Logan University
Doctorate, Clinical Sciences
Martin Junior High
Martin Junior High
North Carolina State University
B.S., Pre-Medicine
Colin Neill Colin Neill's ClinTrials Research Inc, Experience 1998 - 2001
Job Board Member and Chair of Audit Committee at Boston Therapeutics Inc.
Industry Biotechnology
Experience
Boston Therapeutics Inc. December 2013 - Present
Children's Medical Research Foundation, Inc ( CMRF, Inc) July 2013 - Present
Pharmos Corporation 2006 - 2012
Galectin Therapeutics, Inc 2007 - 2011
Oxis International, Inc 2004 - 2008
Axonyx Inc 2003 - 2006
Clintrials Research, Inc. 1998 - 2001
American Express 1983 - 1986
PwC 1975 - 1983
Skills
SEC filings, Sarbanes-Oxley, Registration, Shareholder meetings, Communications and..., Press releases, M&A execution, Working Capital..., Cash Management, Project Management, Capital Raising, Managing Global..., Business Planning, Mergers & Acquisitions, Investor Relations, Finance, Internal Controls, Due Diligence, IPO, Cash Flow, Auditing, Shareholder, Strategy, Internal Audit, Investments, Investment Banking, Press Releases, Private Equity, Financial Modeling, Corporate Finance, Managerial Finance, Financial Services, Acquisition Integration, Restructuring, Divestitures, Executive Management, M&A experience, Valuation, Treasury Management, Venture Capital, Corporate Development, Financial Analysis, Sarbanes-Oxley Act, P&L Management, Strategic Financial..., Structured Finance, GAAP, Capital Markets, US GAAP, Credit
Education
London School of Economics and Political Science 1970 — 1971
Master's degree, Accounting and Finance
Trinity College, Dublin 1966 — 1970
BBS, MA, Business / Economics, Philosophy, Graduated first in class with a First Class Honors degree.
Boston Therapeutics Inc. December 2013 - Present
Children's Medical Research Foundation, Inc ( CMRF, Inc) July 2013 - Present
Pharmos Corporation 2006 - 2012
Galectin Therapeutics, Inc 2007 - 2011
Oxis International, Inc 2004 - 2008
Axonyx Inc 2003 - 2006
Clintrials Research, Inc. 1998 - 2001
American Express 1983 - 1986
PwC 1975 - 1983
Skills
SEC filings, Sarbanes-Oxley, Registration, Shareholder meetings, Communications and..., Press releases, M&A execution, Working Capital..., Cash Management, Project Management, Capital Raising, Managing Global..., Business Planning, Mergers & Acquisitions, Investor Relations, Finance, Internal Controls, Due Diligence, IPO, Cash Flow, Auditing, Shareholder, Strategy, Internal Audit, Investments, Investment Banking, Press Releases, Private Equity, Financial Modeling, Corporate Finance, Managerial Finance, Financial Services, Acquisition Integration, Restructuring, Divestitures, Executive Management, M&A experience, Valuation, Treasury Management, Venture Capital, Corporate Development, Financial Analysis, Sarbanes-Oxley Act, P&L Management, Strategic Financial..., Structured Finance, GAAP, Capital Markets, US GAAP, Credit
Education
London School of Economics and Political Science 1970 — 1971
Master's degree, Accounting and Finance
Trinity College, Dublin 1966 — 1970
BBS, MA, Business / Economics, Philosophy, Graduated first in class with a First Class Honors degree.
Jeffrey Cohn Jeffrey Cohn's ClinTrials Research Inc, Experience December 1996 - July 1999
Job Senior Medical Writer at inVentiv Health Clinical
Industry Pharmaceuticals
Experience
inVentiv Health Clinical May 2013 - Present
Whitsell Innovations July 2012 - June 2013
Tab Clinical Trials July 2012 - April 2013
Salix Pharmaceutical, Inc June 2009 - April 2012
INC Research January 2008 - June 2009
GlaxoSmithKline September 2004 - December 2007
GlaxoSmithKline May 2001 - September 2004
GlaxoWellcome Inc July 1999 - May 2001
ClinTrials Research Inc December 1996 - July 1999
Duke University Medical Center January 1995 - January 1997
Skills
Medical Writing, Publication Planning, Neuroscience, Psychology, Gastroenterology, Psychiatry, Clinical development, Protocol Development, Clinical Development, Protocol, Therapeutic Areas, Clinical Trials, GCP, Pharmaceutical Industry, Regulatory Submissions, Regulatory Affairs, Clinical Research
Education
Tulane University 1983 — 1988
M.S. Ph.D., Experimental Psychology
University of Rhode Island 1979 — 1982
B.A., Psychology
inVentiv Health Clinical May 2013 - Present
Whitsell Innovations July 2012 - June 2013
Tab Clinical Trials July 2012 - April 2013
Salix Pharmaceutical, Inc June 2009 - April 2012
INC Research January 2008 - June 2009
GlaxoSmithKline September 2004 - December 2007
GlaxoSmithKline May 2001 - September 2004
GlaxoWellcome Inc July 1999 - May 2001
ClinTrials Research Inc December 1996 - July 1999
Duke University Medical Center January 1995 - January 1997
Skills
Medical Writing, Publication Planning, Neuroscience, Psychology, Gastroenterology, Psychiatry, Clinical development, Protocol Development, Clinical Development, Protocol, Therapeutic Areas, Clinical Trials, GCP, Pharmaceutical Industry, Regulatory Submissions, Regulatory Affairs, Clinical Research
Education
Tulane University 1983 — 1988
M.S. Ph.D., Experimental Psychology
University of Rhode Island 1979 — 1982
B.A., Psychology
Kathy Mahan Kathy Mahan's ClinTrials Research Inc, Experience June 1997 - October 1998
Job Staff Accountant at The Copernicus Group IRB
Industry Accounting
Experience
The Copernicus Group IRB July 2014 - Present
Autism Society of North Carolina June 2012 - Present
ECO, CORP. June 2013 - June 2014
Accentuate Staffing July 2012 - June 2013
Pfizer February 2011 - June 2012
King Pharmaceuticals (Acquired by Pfizer) April 2000 - February 2011
Medco Research, Inc. (Acquired by King) October 1998 - April 2000
ClinTrials Research, Inc. June 1997 - October 1998
Skills
SAP ERP, SAP Implementation, SAP R/3, SAP BW, Financial Accounting, SAP PS, TM1, Financial Analysis, Analytical Skills, Budget Setting, Forecasting, Department Budgeting, Managing Project Budgets, Quarterly Reporting, Trial Balance, Balance Sheet, Auditing, Validation, Month End Close, Monthly Closing, Monthly Close Process, General Ledger, Account Reconciliation, Amortization Schedules, Fixed Assets, Investments, Royalties, Accounts Payable, Accounts Receivable, Bank Reconciliation, Integration, Integrity, Quantitative, Business Process, Due Diligence, Data Migration, User Training, Acquisition Integration, Cost Center Management, Invoice Finance, Purchase Orders, Payroll, P&L Responsibility, Financial..., Methodical, Program Management, Process Improvement, Corporate Finance, Project Finance, Liaison
Education
Pfeiffer University, B.S. in Business Administration (Finance)
Bachelor of Science in Business Administration, Finance and Management
Pfeiffer University, B.S. in Economics
Bachelor of Science in Economics
Durham Technical Community College
Continuing Education
Wake Technical Community College
Continuing Education
The Copernicus Group IRB July 2014 - Present
Autism Society of North Carolina June 2012 - Present
ECO, CORP. June 2013 - June 2014
Accentuate Staffing July 2012 - June 2013
Pfizer February 2011 - June 2012
King Pharmaceuticals (Acquired by Pfizer) April 2000 - February 2011
Medco Research, Inc. (Acquired by King) October 1998 - April 2000
ClinTrials Research, Inc. June 1997 - October 1998
Skills
SAP ERP, SAP Implementation, SAP R/3, SAP BW, Financial Accounting, SAP PS, TM1, Financial Analysis, Analytical Skills, Budget Setting, Forecasting, Department Budgeting, Managing Project Budgets, Quarterly Reporting, Trial Balance, Balance Sheet, Auditing, Validation, Month End Close, Monthly Closing, Monthly Close Process, General Ledger, Account Reconciliation, Amortization Schedules, Fixed Assets, Investments, Royalties, Accounts Payable, Accounts Receivable, Bank Reconciliation, Integration, Integrity, Quantitative, Business Process, Due Diligence, Data Migration, User Training, Acquisition Integration, Cost Center Management, Invoice Finance, Purchase Orders, Payroll, P&L Responsibility, Financial..., Methodical, Program Management, Process Improvement, Corporate Finance, Project Finance, Liaison
Education
Pfeiffer University, B.S. in Business Administration (Finance)
Bachelor of Science in Business Administration, Finance and Management
Pfeiffer University, B.S. in Economics
Bachelor of Science in Economics
Durham Technical Community College
Continuing Education
Wake Technical Community College
Continuing Education
Chris Decker Chris Decker's ClinTrials Research Inc, Experience 1995 - 1996
Job VP, Life Sciences Practice
Industry Computer Software
Experience
d-Wise Technologies, Inc. February 2008 - Present
PhUSE January 2008 - Present
SAS November 2000 - February 2008
GlaxoSmithKline May 1993 - November 2000
ClinTrials Research, Inc. 1995 - 1996
Skills
SAS programming, Statistics, CRO, Data Mining, Predictive Analytics, Business Process..., Standards Compliance, SAS, Data Management, Data Warehousing, Clinical Trials, CDISC, Lifesciences
Education
North Carolina State University 1993 — 1995
Masters, Statistics
Virginia Polytechnic Institute and State University 1989 — 1993
BS, Major: Statistics Minor: Economics, Computer Science
d-Wise Technologies, Inc. February 2008 - Present
PhUSE January 2008 - Present
SAS November 2000 - February 2008
GlaxoSmithKline May 1993 - November 2000
ClinTrials Research, Inc. 1995 - 1996
Skills
SAS programming, Statistics, CRO, Data Mining, Predictive Analytics, Business Process..., Standards Compliance, SAS, Data Management, Data Warehousing, Clinical Trials, CDISC, Lifesciences
Education
North Carolina State University 1993 — 1995
Masters, Statistics
Virginia Polytechnic Institute and State University 1989 — 1993
BS, Major: Statistics Minor: Economics, Computer Science
Eric Lamb Eric Lamb's ClinTrials Research Inc, Experience June 1995 - August 1997
Job Project Director at Chiltern International
Industry Research
Experience
Chiltern April 2015 - Present
GSK August 1997 - March 2015
Clintrials Research, Inc June 1995 - August 1997
LabCorp August 1988 - November 1994
Skills
Project Management, Clinical Development, CTMS, EDC, Clinical Trials, CRO, Adjudication, Protocol Development, Clinical Monitoring, Pharmaceutical Industry, Clinical Operations, ICH-GCP, GCP, Clinical Research, Clinical Data Management, Oncology, Protocol, Infectious Diseases
Education
North Carolina State University 1983 — 1988
Bachelor's Degree, Biology/Biological Sciences, General
Northwest Guilford 1980 — 1983
High School Diploma
Chiltern April 2015 - Present
GSK August 1997 - March 2015
Clintrials Research, Inc June 1995 - August 1997
LabCorp August 1988 - November 1994
Skills
Project Management, Clinical Development, CTMS, EDC, Clinical Trials, CRO, Adjudication, Protocol Development, Clinical Monitoring, Pharmaceutical Industry, Clinical Operations, ICH-GCP, GCP, Clinical Research, Clinical Data Management, Oncology, Protocol, Infectious Diseases
Education
North Carolina State University 1983 — 1988
Bachelor's Degree, Biology/Biological Sciences, General
Northwest Guilford 1980 — 1983
High School Diploma
Mary Chaput Mary Chaput's ClinTrials Research Inc, Experience 1996 - 1999
Job CFO & Compliance Officer at Clearwater Compliance
Industry Hospital & Health Care
Experience
Clearwater Compliance LLC January 2012 - Present
Healthways October 2001 - December 2011
Paragon Ventures Group 1999 - 2001
ClinTrials Research, Inc. 1996 - 1999
APBI 1993 - 1996
GE 1976 - 1993
Coleco Industries 1982 - 1986
Skills
HIPAA, Medicare, Managed Care, Healthcare Information..., Healthcare, Strategic Planning, Business Development, Business Strategy, Management, Software Documentation, Financial Analysis, Business Analysis, Process Improvement, Financial Reporting, Risk Management, Medicaid, Healthcare Management, Sales, Leadership, Clinical Research, Finance, Budgets, Due Diligence, Start-ups, Healthcare Industry, Executive Management, Business Planning, Internal Audit, Analysis, Healthcare Consulting, Policy, Accounting, Insurance, Mergers, Program Management
Education
University at Albany, SUNY 1982 — 1985
MBA
GE Financial Management Program 1977 — 1979
Russell Sage College 1967 — 1971
BA-Math
Clearwater Compliance LLC January 2012 - Present
Healthways October 2001 - December 2011
Paragon Ventures Group 1999 - 2001
ClinTrials Research, Inc. 1996 - 1999
APBI 1993 - 1996
GE 1976 - 1993
Coleco Industries 1982 - 1986
Skills
HIPAA, Medicare, Managed Care, Healthcare Information..., Healthcare, Strategic Planning, Business Development, Business Strategy, Management, Software Documentation, Financial Analysis, Business Analysis, Process Improvement, Financial Reporting, Risk Management, Medicaid, Healthcare Management, Sales, Leadership, Clinical Research, Finance, Budgets, Due Diligence, Start-ups, Healthcare Industry, Executive Management, Business Planning, Internal Audit, Analysis, Healthcare Consulting, Policy, Accounting, Insurance, Mergers, Program Management
Education
University at Albany, SUNY 1982 — 1985
MBA
GE Financial Management Program 1977 — 1979
Russell Sage College 1967 — 1971
BA-Math
Robin Woodlief Robin Woodlief's ClinTrials Research Inc, Experience May 1992 - February 1998
Job CFO/Controller
Industry Computer Software
Experience
Poyner Spruill LLP May 2015 - Present
Tavve Software Company April 2000 - April 2014
nTouch Research Inc March 1998 - December 1999
ClinTrials Research, Inc May 1992 - February 1998
Deloitte July 1984 - April 1992
Skills
Start-ups, Financial Analysis, Finance, Accounting, Managerial Finance, Budgets, Auditing, Management, Cash Management, Human Resources, Financial Statements, Contract Negotiation
Education
Meredith College 1980 — 1984
B.S, Business Administration
Smithfield Selma Senior High 1976 — 1980
North Carolina State University
Accounting, 1984
Poyner Spruill LLP May 2015 - Present
Tavve Software Company April 2000 - April 2014
nTouch Research Inc March 1998 - December 1999
ClinTrials Research, Inc May 1992 - February 1998
Deloitte July 1984 - April 1992
Skills
Start-ups, Financial Analysis, Finance, Accounting, Managerial Finance, Budgets, Auditing, Management, Cash Management, Human Resources, Financial Statements, Contract Negotiation
Education
Meredith College 1980 — 1984
B.S, Business Administration
Smithfield Selma Senior High 1976 — 1980
North Carolina State University
Accounting, 1984
Gary Cline Gary Cline's ClinTrials Research Inc, Experience June 1997 - June 1998
Job Executive Director of Biostatistics at Celgene
Industry Pharmaceuticals
Experience
Celgene June 2015 - Present
Celgene August 2012 - Present
ICON Clinical Research May 2012 - August 2012
ICON Clinical Research May 2009 - May 2012
Procter & Gamble Pharmaceuticals August 2004 - May 2009
Procter & Gamble Pharmaceuticals June 1998 - July 2004
ClinTrials Research Inc. June 1997 - June 1998
Skills
Biostatistics, Oncology, Osteoporosis, Pharmaceutical Industry, Rheumatoid Arthritis, Infectious Diseases
Education
University of Kentucky 1993 — 1997
PhD, MS, Statistics
Eastern Kentucky University 1987 — 1994
MS, BS, Math
Celgene June 2015 - Present
Celgene August 2012 - Present
ICON Clinical Research May 2012 - August 2012
ICON Clinical Research May 2009 - May 2012
Procter & Gamble Pharmaceuticals August 2004 - May 2009
Procter & Gamble Pharmaceuticals June 1998 - July 2004
ClinTrials Research Inc. June 1997 - June 1998
Skills
Biostatistics, Oncology, Osteoporosis, Pharmaceutical Industry, Rheumatoid Arthritis, Infectious Diseases
Education
University of Kentucky 1993 — 1997
PhD, MS, Statistics
Eastern Kentucky University 1987 — 1994
MS, BS, Math
Samantha Lofton Samantha Lofton's ClinTrials Research Inc, Experience 1993 - 1998
Job Chief Risk and Information Governance Officer at Ice Miller LLP
Industry Legal Services
Experience
Ice Miller LLP 2015 - Present
Ice Miller 2010 - 2014
ARMA International 2009 - 2012
Greenebaum Doll & McDonald PLLC 1998 - 2010
Clintrials Research, Inc 1993 - 1998
Skills
Records Management, Information Management, Litigation Support, Document Management, Information Governance, Privacy Law, SharePoint, Legal Assistance, Enterprise Content..., Records, EDRMS, Knowledge Management, Governance, Metadata, Content Management, Archives, Process Improvement, Corporate Law, Legal Compliance, Policy, Document Imaging, Litigation, Document Review, Enterprise Software, Corporate Governance, Risk Management, Intellectual Property, Data Privacy, Legal Writing, Westlaw, Legal Research, Taxonomy
Education
University of Kentucky
Bachelor's Degree, Management and Decision Science/ Information Systems
Bluegrass Community and Technical College
Associate of Arts (A.A.), Focuses in Business and Communications
Bluegrass Community and Technical College
Associate of Science (A.S.)
Ice Miller LLP 2015 - Present
Ice Miller 2010 - 2014
ARMA International 2009 - 2012
Greenebaum Doll & McDonald PLLC 1998 - 2010
Clintrials Research, Inc 1993 - 1998
Skills
Records Management, Information Management, Litigation Support, Document Management, Information Governance, Privacy Law, SharePoint, Legal Assistance, Enterprise Content..., Records, EDRMS, Knowledge Management, Governance, Metadata, Content Management, Archives, Process Improvement, Corporate Law, Legal Compliance, Policy, Document Imaging, Litigation, Document Review, Enterprise Software, Corporate Governance, Risk Management, Intellectual Property, Data Privacy, Legal Writing, Westlaw, Legal Research, Taxonomy
Education
University of Kentucky
Bachelor's Degree, Management and Decision Science/ Information Systems
Bluegrass Community and Technical College
Associate of Arts (A.A.), Focuses in Business and Communications
Bluegrass Community and Technical College
Associate of Science (A.S.)
Kenneth Shane Baldwin's ClinTrials Research Inc, Experience September 1997 - December 1999
Job Senior Director Quality Assurance at Neurocog Trials
Industry Pharmaceuticals
Experience
Neurocog Trials February 2013 - Present
POZEN June 2006 - January 2013
Duke Clinical Research Institute December 1999 - May 2006
ClinTrials Research Inc September 1997 - December 1999
Quintiles November 1992 - September 1997
Skills
Clinical Data Management, GCP, CRO, Clinical Trials, Sop, Pharmaceutical Industry, 21 CFR Part 11, EDC, Clinical Research
Education
North Carolina State University
BA English
Neurocog Trials February 2013 - Present
POZEN June 2006 - January 2013
Duke Clinical Research Institute December 1999 - May 2006
ClinTrials Research Inc September 1997 - December 1999
Quintiles November 1992 - September 1997
Skills
Clinical Data Management, GCP, CRO, Clinical Trials, Sop, Pharmaceutical Industry, 21 CFR Part 11, EDC, Clinical Research
Education
North Carolina State University
BA English
Otho Lee (Sonny) Armstrong Otho Lee (Sonny) Armstrong's ClinTrials Research Inc, Experience August 1996 - March 1999
Job Safely bringing new drugs to market since 1996 as a: CCRALCRARAAPM
Industry Research
Experience
Kinetic Marketing & Research June 2001 - Present
PRA International April 2000 - June 2001
TrialStar, Inc April 1999 - October 1999
ClinTrials Research, Inc August 1996 - March 1999
Skills
Phase I, Neurology, Clinical Trials, Regulatory Affairs, Allergy, Asthma, Gastroenterology, Nephrology, Ophthalmology, Lead CRA, Quality Assurance, Pediatrics, Clinical Project..., FDA ICH guidelines, good clinical practice, Pulmonology, Certified CRA, CRA Manager, Senior Regional CRA, Regulatory Associate, AE & SAE reporting, IRB reporting, Client Services, Educated, Confident, Team leader & trainer, Manage multiple..., sponsor relations, Site Selection, pre-clinical scientist, Phase II, Phase III, Phase IV, Anti-infectives- 3 years, Biologics - 3 years', HIV/AIDS - 3 years, Medical Device Product..., Nutrition, Oncology/Hematology - 7..., Orthopedics - 4 years, Pain, Xenotransplant studies, Environmental Project..., Industrial Hygiene, Study start-up, Cardiovascular Disease, Project Management, Clinical Monitoring, Sponsorship, Trial Management
Education
Lipscomb University 1981 — 1983
Bachelor of Science, Applied Chemistry & Biology
Kinetic Marketing & Research June 2001 - Present
PRA International April 2000 - June 2001
TrialStar, Inc April 1999 - October 1999
ClinTrials Research, Inc August 1996 - March 1999
Skills
Phase I, Neurology, Clinical Trials, Regulatory Affairs, Allergy, Asthma, Gastroenterology, Nephrology, Ophthalmology, Lead CRA, Quality Assurance, Pediatrics, Clinical Project..., FDA ICH guidelines, good clinical practice, Pulmonology, Certified CRA, CRA Manager, Senior Regional CRA, Regulatory Associate, AE & SAE reporting, IRB reporting, Client Services, Educated, Confident, Team leader & trainer, Manage multiple..., sponsor relations, Site Selection, pre-clinical scientist, Phase II, Phase III, Phase IV, Anti-infectives- 3 years, Biologics - 3 years', HIV/AIDS - 3 years, Medical Device Product..., Nutrition, Oncology/Hematology - 7..., Orthopedics - 4 years, Pain, Xenotransplant studies, Environmental Project..., Industrial Hygiene, Study start-up, Cardiovascular Disease, Project Management, Clinical Monitoring, Sponsorship, Trial Management
Education
Lipscomb University 1981 — 1983
Bachelor of Science, Applied Chemistry & Biology
James Baxter James Baxter's ClinTrials Research Inc, Experience 1992 - 1995
Job Senior Vice President at InfoPartners, Inc.
Industry Information Technology and Services
Experience
InfoPartners, Inc. 1995 - Present
ClinTrials Research, Inc. 1992 - 1995
SmithKline Beecham Clinical Laboratories, Inc. 1987 - 1992
Skills
Hospitals, Healthcare, Healthcare Information..., EMR, EHR, Informatics, Revenue Cycle, HIPAA, Healthcare Consulting, Healthcare Management, Practice Management, Healthcare Industry, HL7, Epic Systems, Ambulatory, Integration, Health Information..., Revenue Cycle Management, Meditech, Information Technology, Consulting, Cerner, Medicaid, Physicians, Software Implementation
Education
Vanderbilt University - Owen Graduate School of Management 1984 — 1986
MBA, Marketing & Finance
Birmingham-Southern College 1977 — 1981
B.S.
InfoPartners, Inc. 1995 - Present
ClinTrials Research, Inc. 1992 - 1995
SmithKline Beecham Clinical Laboratories, Inc. 1987 - 1992
Skills
Hospitals, Healthcare, Healthcare Information..., EMR, EHR, Informatics, Revenue Cycle, HIPAA, Healthcare Consulting, Healthcare Management, Practice Management, Healthcare Industry, HL7, Epic Systems, Ambulatory, Integration, Health Information..., Revenue Cycle Management, Meditech, Information Technology, Consulting, Cerner, Medicaid, Physicians, Software Implementation
Education
Vanderbilt University - Owen Graduate School of Management 1984 — 1986
MBA, Marketing & Finance
Birmingham-Southern College 1977 — 1981
B.S.
Sagoo Kapur Sagoo Kapur's ClinTrials Research Inc, Experience December 1996 - February 1998
Job Pharmacist at North Carolina Dept. of Public Safety
Industry Pharmaceuticals
Experience
North Carolina Department of Public Safety March 2005 - Present
Medical Solutions of America, Inc September 2002 - October 2004
Kerr Drugs May 2001 - December 2002
DesignWrite, Inc May 2000 - December 2000
GlaxoWellcome, Inc May 1998 - March 1999
ClinTrials Research, Inc December 1996 - February 1998
Duke University Medical Center March 1996 - December 1996
Warren Drug Company February 1995 - September 1996
Cape Fear Valley Medical Center January 1994 - June 1995
Primus Clinic April 1993 - January 1994
Skills
Clinical Research, Hospitals, Pharmacists, Healthcare, Clinical, Medical Writing, Customer Service, Problem Solving, Clinical Monitoring, Ambulatory Care, Pediatrics, Type 1 Diabetes, Medicine, Critical Care, Pharmacokinetics, Inpatient, Pain Management, Pharmacy, Diabetes, Certified Immunizer
Education
Campbell University 1995 — 1996
Pharm.D, Pharmacy
Rutgers University-New Brunswick 1985 — 1990
B.S., Pharmacy
North Carolina Department of Public Safety March 2005 - Present
Medical Solutions of America, Inc September 2002 - October 2004
Kerr Drugs May 2001 - December 2002
DesignWrite, Inc May 2000 - December 2000
GlaxoWellcome, Inc May 1998 - March 1999
ClinTrials Research, Inc December 1996 - February 1998
Duke University Medical Center March 1996 - December 1996
Warren Drug Company February 1995 - September 1996
Cape Fear Valley Medical Center January 1994 - June 1995
Primus Clinic April 1993 - January 1994
Skills
Clinical Research, Hospitals, Pharmacists, Healthcare, Clinical, Medical Writing, Customer Service, Problem Solving, Clinical Monitoring, Ambulatory Care, Pediatrics, Type 1 Diabetes, Medicine, Critical Care, Pharmacokinetics, Inpatient, Pain Management, Pharmacy, Diabetes, Certified Immunizer
Education
Campbell University 1995 — 1996
Pharm.D, Pharmacy
Rutgers University-New Brunswick 1985 — 1990
B.S., Pharmacy
Joe Eastman Joe Eastman's ClinTrials Research Inc, Experience January 1996 - January 1997
Job Director, Physician Medical Affairs Leader at Stiefel, a GSK company
Industry Pharmaceuticals
Experience
Stiefel, a GSK company February 2011 - Present
Stiefel, a GSK company October 2008 - February 2011
INC Research January 2007 - October 2008
Quintiles Inc January 2000 - January 2004
Quintiles Inc January 1999 - January 2000
Quintiles Inc January 1998 - January 1999
The Woolf Group January 1997 - January 1998
ClinTrials Research, Inc January 1996 - January 1997
Health Sciences Consortium January 1993 - January 1996
Skills
Dermatology, Medical Affairs, Pharmacovigilance, Clinical Development, Medical Writing, Pharmaceutics, Medicine, Pharmaceutical Industry, Clinical Trials, CRO, GCP, CTMS, Oncology, Regulatory Submissions, Sop, Regulatory Affairs, Clinical Research, Clinical Study Design, Clinical Data Management
Education
The Brody School of Medicine at East Carolina University 1989 — 1993
MD, Medicine
University of North Carolina at Chapel Hill 1985 — 1989
BA, Biology / Chemistry
Stiefel, a GSK company February 2011 - Present
Stiefel, a GSK company October 2008 - February 2011
INC Research January 2007 - October 2008
Quintiles Inc January 2000 - January 2004
Quintiles Inc January 1999 - January 2000
Quintiles Inc January 1998 - January 1999
The Woolf Group January 1997 - January 1998
ClinTrials Research, Inc January 1996 - January 1997
Health Sciences Consortium January 1993 - January 1996
Skills
Dermatology, Medical Affairs, Pharmacovigilance, Clinical Development, Medical Writing, Pharmaceutics, Medicine, Pharmaceutical Industry, Clinical Trials, CRO, GCP, CTMS, Oncology, Regulatory Submissions, Sop, Regulatory Affairs, Clinical Research, Clinical Study Design, Clinical Data Management
Education
The Brody School of Medicine at East Carolina University 1989 — 1993
MD, Medicine
University of North Carolina at Chapel Hill 1985 — 1989
BA, Biology / Chemistry
Jennifer Charron's ClinTrials Research Inc, Experience June 1995 - August 1996
Job Executive Director and General Manager, Strategic Solutions at PRA Health Sciences
Industry Pharmaceuticals
Experience
PRA Health Sciences November 2014 - Present
Live Oak Cafe January 2002 - Present
Research Pharmaceutical Services (RPS) January 2013 - October 2014
Research Pharmaceutical Services (RPS) January 2010 - December 2012
Research Pharmaceutical Services (RPS) July 2007 - December 2009
Kforce/Roche August 2004 - July 2007
PAREXEL March 2001 - July 2004
PAREXEL July 1999 - March 2001
PAREXEL August 1996 - July 1999
Clintrials Research, Inc June 1995 - August 1996
Skills
Clinical Research, CTMS, Clinical Trials, Clinical Monitoring, Medical Devices, EDC, Infectious Diseases, Pharmaceutical Industry, ICH-GCP, Oncology
Education
University of North Carolina at Chapel Hill 1990 — 1992
BA, Art History, English
Boston University 1988 — 1990
Art History, English
PRA Health Sciences November 2014 - Present
Live Oak Cafe January 2002 - Present
Research Pharmaceutical Services (RPS) January 2013 - October 2014
Research Pharmaceutical Services (RPS) January 2010 - December 2012
Research Pharmaceutical Services (RPS) July 2007 - December 2009
Kforce/Roche August 2004 - July 2007
PAREXEL March 2001 - July 2004
PAREXEL July 1999 - March 2001
PAREXEL August 1996 - July 1999
Clintrials Research, Inc June 1995 - August 1996
Skills
Clinical Research, CTMS, Clinical Trials, Clinical Monitoring, Medical Devices, EDC, Infectious Diseases, Pharmaceutical Industry, ICH-GCP, Oncology
Education
University of North Carolina at Chapel Hill 1990 — 1992
BA, Art History, English
Boston University 1988 — 1990
Art History, English
Peggy Gratta Peggy Gratta's ClinTrials Research Inc, Experience August 1990 - September 1995
Job Clinical Resourcing Manager at Catalyst Clinical Resourcing, LLC
Industry Research
Experience
Catalyst Clinical Resourcing, LLC October 2013 - Present
Trio Clinical Resourcing January 2011 - October 2013
Trio Clinical Research, Inc January 2006 - December 2010
Independent Clinical Research Consultant February 2004 - December 2005
Trimeris September 2001 - January 2004
the woolf group January 1998 - August 2001
Duke Clinical Research Institute November 1995 - June 1997
ClinTrials Research, Inc August 1990 - September 1995
Various Hospitals 1972 - 1990
Skills
Clinical Monitoring, Clinical Research, EDC, CRO, Clinical Trials, Phase I, CTMS, Clinical Development, Clinical Operations, GCP, ICH-GCP
Education
St. Joseph's College (ME)
Bachelor of Science (BS), Health/Health Care Administration/Management
Watts School of Nursing
Registered Nurse
Catalyst Clinical Resourcing, LLC October 2013 - Present
Trio Clinical Resourcing January 2011 - October 2013
Trio Clinical Research, Inc January 2006 - December 2010
Independent Clinical Research Consultant February 2004 - December 2005
Trimeris September 2001 - January 2004
the woolf group January 1998 - August 2001
Duke Clinical Research Institute November 1995 - June 1997
ClinTrials Research, Inc August 1990 - September 1995
Various Hospitals 1972 - 1990
Skills
Clinical Monitoring, Clinical Research, EDC, CRO, Clinical Trials, Phase I, CTMS, Clinical Development, Clinical Operations, GCP, ICH-GCP
Education
St. Joseph's College (ME)
Bachelor of Science (BS), Health/Health Care Administration/Management
Watts School of Nursing
Registered Nurse
Kristi Wubbe Kristi Wubbe's ClinTrials Research Inc, Experience September 1993 - November 1994
Job 8th Grade English Teacher @ Winchester Public Schools
Industry Primary/Secondary Education
Experience
Winchester Public Schools August 2014 - Present
Frederick County Public Schools August 2007 - June 2014
Sunny 100.7 WCLS Radio September 1996 - August 1997
ClinTrials Research, Inc. September 1993 - November 1994
OMC Fishing Boat Group August 1990 - September 1993
Media Direct Industries, Inc. October 1987 - October 1989
Skills
Lesson Planning, Differentiated..., Classroom, Tutoring, Special Education, Secondary Education, Smartboard, Educational Technology, Language Arts, Community Outreach, Editing, Learning Disabilities, IEP, Reading Intervention, Nonprofits, Event Planning, Classroom Management, Public Speaking, Curriculum Design, Teaching, Common Core State..., Teaching Writing, Professional Learning..., Training, 21st Century Skills, Integrating Technology..., Technology Integration, Teacher Training
Education
James Madison University 2006 — 2008
Master of Arts in Teaching (MAT), Special Education K-12, English 6-8, History 6-8
George Mason University
Winchester Public Schools August 2014 - Present
Frederick County Public Schools August 2007 - June 2014
Sunny 100.7 WCLS Radio September 1996 - August 1997
ClinTrials Research, Inc. September 1993 - November 1994
OMC Fishing Boat Group August 1990 - September 1993
Media Direct Industries, Inc. October 1987 - October 1989
Skills
Lesson Planning, Differentiated..., Classroom, Tutoring, Special Education, Secondary Education, Smartboard, Educational Technology, Language Arts, Community Outreach, Editing, Learning Disabilities, IEP, Reading Intervention, Nonprofits, Event Planning, Classroom Management, Public Speaking, Curriculum Design, Teaching, Common Core State..., Teaching Writing, Professional Learning..., Training, 21st Century Skills, Integrating Technology..., Technology Integration, Teacher Training
Education
James Madison University 2006 — 2008
Master of Arts in Teaching (MAT), Special Education K-12, English 6-8, History 6-8
George Mason University
Charles Tracey Lancaster Charles Tracey Lancaster's ClinTrials Research Inc, Experience February 1995 - June 1996
Job Clinical Project Manager
Industry Pharmaceuticals
Experience
MedSource March 2013 - Present
PPD August 2007 - January 2013
GlaxoSmithKline 1996 - 2007
ClinTrials Research, Inc February 1995 - June 1996
University of North Carolina June 1993 - February 1995
Skills
Pharmaceuticals, Clinical Trials, Clinical Development, Research Project..., Clinical Research, Program Management, Risk Management, CRO, Project Planning, Project Execution, Project Delivery, Safety Management, Vendor Management, Publication Writing, Publication Development, Publications Management, Contract Management, Database Design, Visual Basic, Regulatory Submissions, Regulatory Reporting, Reporting & Analysis, Performance Reporting, CTMS, Clinical Pharmacology, Drug Development, Infectious Diseases, Oncology, Pharmaceutical Industry, Pharmaceutics, Project Management, Publications, Safety Management...
Education
North Carolina State University 1984 — 1989
BA, Chemistry
MedSource March 2013 - Present
PPD August 2007 - January 2013
GlaxoSmithKline 1996 - 2007
ClinTrials Research, Inc February 1995 - June 1996
University of North Carolina June 1993 - February 1995
Skills
Pharmaceuticals, Clinical Trials, Clinical Development, Research Project..., Clinical Research, Program Management, Risk Management, CRO, Project Planning, Project Execution, Project Delivery, Safety Management, Vendor Management, Publication Writing, Publication Development, Publications Management, Contract Management, Database Design, Visual Basic, Regulatory Submissions, Regulatory Reporting, Reporting & Analysis, Performance Reporting, CTMS, Clinical Pharmacology, Drug Development, Infectious Diseases, Oncology, Pharmaceutical Industry, Pharmaceutics, Project Management, Publications, Safety Management...
Education
North Carolina State University 1984 — 1989
BA, Chemistry
Laura Anderson, PMP Laura Anderson, PMP's ClinTrials Research Inc, Experience 1996 - 1998
Job Customer Proj/Prgm Mgr III at Hewlett Packard Enterprise Services
Industry Information Technology and Services
Experience
Hewlett Packard Enterprise Services November 2010 - Present
ACC, Inc. January 2003 - November 2010
Alliance for Multispecialty Research, LLC 1998 - 2001
ClinTrials Research, Inc 1996 - 1998
Vanderbilt University Medical Center 1993 - 1996
Skills
SDLC, PMP, Program Management, Business Analysis, Project Management, Process Improvement, Vendor Management, PMO, Visio, Change Management, Software Project..., Contract Negotiation, Contract Management, Software Cost Estimation, Operations Management, Project Portfolio..., Budgets, Analysis, Cross-functional Team..., Team Leadership, Project Delivery, Project Planning, Integration, Leadership, Management Consulting, Business Process..., IT Management, IT Strategy, Quality Assurance, Strategy, Business Process, Management, Service Delivery, Software Documentation, Requirements Analysis, Team Building, Resource Management, MS Project, Networking, SharePoint, IT Service Management, Requirements Gathering, Risk Management
Education
Project Management Institute 2010 — 2010
PMP, Certified Project Management Professional
Lipscomb University 1995 — 1995
Vanderbilt University 1986 — 1990
BA, English
Hewlett Packard Enterprise Services November 2010 - Present
ACC, Inc. January 2003 - November 2010
Alliance for Multispecialty Research, LLC 1998 - 2001
ClinTrials Research, Inc 1996 - 1998
Vanderbilt University Medical Center 1993 - 1996
Skills
SDLC, PMP, Program Management, Business Analysis, Project Management, Process Improvement, Vendor Management, PMO, Visio, Change Management, Software Project..., Contract Negotiation, Contract Management, Software Cost Estimation, Operations Management, Project Portfolio..., Budgets, Analysis, Cross-functional Team..., Team Leadership, Project Delivery, Project Planning, Integration, Leadership, Management Consulting, Business Process..., IT Management, IT Strategy, Quality Assurance, Strategy, Business Process, Management, Service Delivery, Software Documentation, Requirements Analysis, Team Building, Resource Management, MS Project, Networking, SharePoint, IT Service Management, Requirements Gathering, Risk Management
Education
Project Management Institute 2010 — 2010
PMP, Certified Project Management Professional
Lipscomb University 1995 — 1995
Vanderbilt University 1986 — 1990
BA, English
Melissa L. Pochop-Miller Melissa L. Pochop-Miller's ClinTrials Research Inc, Experience 1995 - 1996
Job Senior Director, Hematology/Oncology, Global Project Management at PPD
Industry Pharmaceuticals
Experience
PPD September 2015 - Present
Physio-Control, Inc. July 2013 - September 2015
Ocean Cardiovascular Consultants May 2012 - July 2013
PRA International May 2010 - April 2012
Philips Healthcare December 2007 - February 2010
Quintiles, Inc August 2006 - September 2007
Quintiles 1997 - 2006
BIOTRONIK 1996 - 1997
ClinTrials Research, Inc 1995 - 1996
Cardiac Control Systems, Inc 1994 - 1995
Skills
Clinical Trials, Medical Devices, Cross-functional Team..., Drug Development, Pharmaceutical Industry, Product Development, Product Management, Process Improvement, Strategic Planning, Product Marketing, Contract Negotiation, Contract Management, Mentoring Of Staff, Change Management, Employee Engagement, Medical Device R&D, Marketing Strategy, Upstream Marketing, Training Delivery, Technical Presentations, Biotechnology Industry, Operational Excellence, Risk Management, Strategic Alliances, Client Presentation, Global Program..., Product Portfolio..., Oncology Clinical..., Cardiovascular Clinical..., Global Program..., Managing Partner..., Multi-cultural Team..., Highly Effective Teams, Client Liaison, Operational Strategy, Global Delivery, Corporate Governance, Proposal Generation, Employee Management, Marketing Management, Go-to-market Strategy, Product Launch, Implantable..., Cardiovascular Medical..., Cardiac Monitoring, Cardiac..., AED, Surgical Support, Pacemakers
Education
Arizona State University 1982 — 1986
BSE, Biomedical Engineering
PPD September 2015 - Present
Physio-Control, Inc. July 2013 - September 2015
Ocean Cardiovascular Consultants May 2012 - July 2013
PRA International May 2010 - April 2012
Philips Healthcare December 2007 - February 2010
Quintiles, Inc August 2006 - September 2007
Quintiles 1997 - 2006
BIOTRONIK 1996 - 1997
ClinTrials Research, Inc 1995 - 1996
Cardiac Control Systems, Inc 1994 - 1995
Skills
Clinical Trials, Medical Devices, Cross-functional Team..., Drug Development, Pharmaceutical Industry, Product Development, Product Management, Process Improvement, Strategic Planning, Product Marketing, Contract Negotiation, Contract Management, Mentoring Of Staff, Change Management, Employee Engagement, Medical Device R&D, Marketing Strategy, Upstream Marketing, Training Delivery, Technical Presentations, Biotechnology Industry, Operational Excellence, Risk Management, Strategic Alliances, Client Presentation, Global Program..., Product Portfolio..., Oncology Clinical..., Cardiovascular Clinical..., Global Program..., Managing Partner..., Multi-cultural Team..., Highly Effective Teams, Client Liaison, Operational Strategy, Global Delivery, Corporate Governance, Proposal Generation, Employee Management, Marketing Management, Go-to-market Strategy, Product Launch, Implantable..., Cardiovascular Medical..., Cardiac Monitoring, Cardiac..., AED, Surgical Support, Pacemakers
Education
Arizona State University 1982 — 1986
BSE, Biomedical Engineering
Craig Lyon Craig Lyon's ClinTrials Research Inc, Experience 1994 - 1996
Job Principal Writer/Owner of LYONIZE INC, providing writing support to pharmaceutical and biotech industries.
Industry Pharmaceuticals
Experience
Lyonize, Inc. 1999 - Present
Omnicare Clinical Research 1996 - 1999
Clintrials Research, Inc 1994 - 1996
Skills
Medical Writing, Clinical Trials, Technical Writing, Clinical Research, Medical Devices, Editing, Pharmaceutical Industry, CRO, Regulatory Submissions, Biotechnology, Therapeutic Areas, Oncology, Clinical Development
Education
George Mason University 1990 — 1993
MFA, Writing
Old Dominion University
BA, English
Lyonize, Inc. 1999 - Present
Omnicare Clinical Research 1996 - 1999
Clintrials Research, Inc 1994 - 1996
Skills
Medical Writing, Clinical Trials, Technical Writing, Clinical Research, Medical Devices, Editing, Pharmaceutical Industry, CRO, Regulatory Submissions, Biotechnology, Therapeutic Areas, Oncology, Clinical Development
Education
George Mason University 1990 — 1993
MFA, Writing
Old Dominion University
BA, English
Michelle Usher Michelle Usher's ClinTrials Research Inc, Experience December 1996 - November 1997
Job Executive Director, Regulatory Affairs at Furiex Pharmaceuticals, Inc, a subsidiary of Actavis, plc
Industry Pharmaceuticals
Experience
Furiex Pharmaceuticals, Inc, a subsidiary of Actavis, plc June 2010 - July 2015
PPD October 2007 - June 2010
PPD May 1998 - October 2007
PAREXEL November 1997 - May 1998
ClinTrials Research, Inc December 1996 - November 1997
Pharmacia & Upjohn September 1992 - December 1996
Skills
Global Regulatory..., Regulatory Submissions, Regulatory Compliance, Regulatory Strategy..., CMC Regulatory Affairs
Education
North Carolina State University 1981 — 1988
Bachelor of Science (BS), Chemistry
Furiex Pharmaceuticals, Inc, a subsidiary of Actavis, plc June 2010 - July 2015
PPD October 2007 - June 2010
PPD May 1998 - October 2007
PAREXEL November 1997 - May 1998
ClinTrials Research, Inc December 1996 - November 1997
Pharmacia & Upjohn September 1992 - December 1996
Skills
Global Regulatory..., Regulatory Submissions, Regulatory Compliance, Regulatory Strategy..., CMC Regulatory Affairs
Education
North Carolina State University 1981 — 1988
Bachelor of Science (BS), Chemistry
Brent Lambert Brent Lambert's ClinTrials Research Inc, Experience February 1994 - July 1996
Job Principal at South Shore Clinical Consulting, Inc.
Industry Research
Experience
South Shore Clinical Consulting, Inc. Principal Clinical Research ConsultantSouth Shore Clinical Consulting, Inc.November 2001 - Present
Johnson & Johnson Pharmaceutical Research & Development March 1997 - October 2005
Millenium 3 Clinical Consulting, Inc. May 1999 - November 2001
GlaxoWellcome, Inc. July 1996 - March 1997
ClinTrials Research, Inc. February 1994 - July 1996
Mercy Hospital August 1992 - November 1993
Skills
Clinical Trials, CTMS, Clinical Research, GCP, CRO, FDA, Clinical Development, Oncology, Infectious Diseases, Clinical Data Management, Clinical Monitoring, EDC, Regulatory Submissions, ICH-GCP, Pharmaceutical Industry
Education
UNC Chapel Hill 1984 — 1990
MSPH, Public Health
South Shore Clinical Consulting, Inc. Principal Clinical Research ConsultantSouth Shore Clinical Consulting, Inc.November 2001 - Present
Johnson & Johnson Pharmaceutical Research & Development March 1997 - October 2005
Millenium 3 Clinical Consulting, Inc. May 1999 - November 2001
GlaxoWellcome, Inc. July 1996 - March 1997
ClinTrials Research, Inc. February 1994 - July 1996
Mercy Hospital August 1992 - November 1993
Skills
Clinical Trials, CTMS, Clinical Research, GCP, CRO, FDA, Clinical Development, Oncology, Infectious Diseases, Clinical Data Management, Clinical Monitoring, EDC, Regulatory Submissions, ICH-GCP, Pharmaceutical Industry
Education
UNC Chapel Hill 1984 — 1990
MSPH, Public Health
Anita Woodring Anita Woodring's ClinTrials Research Inc, Experience 1993 - 1994
Job Senior Director of Clinical and Regulatory Operations at Parion Sciences Inc.
Industry Pharmaceuticals
Experience
Parion Sciences Inc. June 2014 - Present
RTI International January 2011 - June 2014
Gilead Sciences January 2010 - December 2010
Inspire Pharmaceuticals 2000 - 2010
GSK 1994 - 2000
ClinTrials Research Inc. 1993 - 1994
Education
University of Akron 1985 — 1990
BS, Medical Technology
University of North Carolina at Chapel Hill
MS, Pharmacy Administration
Parion Sciences Inc. June 2014 - Present
RTI International January 2011 - June 2014
Gilead Sciences January 2010 - December 2010
Inspire Pharmaceuticals 2000 - 2010
GSK 1994 - 2000
ClinTrials Research Inc. 1993 - 1994
Education
University of Akron 1985 — 1990
BS, Medical Technology
University of North Carolina at Chapel Hill
MS, Pharmacy Administration
Jeff Simpson Jeff Simpson's ClinTrials Research Inc, Experience July 1996 - November 1997
Job Clinical Operations Lead, UCB BioSciences
Industry Pharmaceuticals
Experience
UCB Biosciences, Inc. May 2013 - Present
Gilead Sciences July 2008 - December 2010
UCB January 2007 - June 2008
SCHWARZ BIOSCIENCES, Inc. September 2001 - December 2006
Triangle Pharmaceuticals, Inc. July 1998 - December 2000
The Woolf Group, Inc. (GlaxoWellcome) November 1997 - July 1998
ClinTrials Research, Inc. July 1996 - November 1997
Laboratory of Neuropharmacology, NIEHS September 1995 - July 1996
Skills
Biotechnology, Infectious Diseases, Pharmaceutical Industry, GCP, CTMS, Clinical Development, Clinical Research, Clinical Monitoring, Clinical Trials, ICH-GCP, CRO, Regulatory Submissions, Drug Development, Sop, Protocol, IND, Software Documentation, Drug Discovery
Education
East Carolina University
Doctor of Philosophy; Bachelor of Science, Neurobiology
UCB Biosciences, Inc. May 2013 - Present
Gilead Sciences July 2008 - December 2010
UCB January 2007 - June 2008
SCHWARZ BIOSCIENCES, Inc. September 2001 - December 2006
Triangle Pharmaceuticals, Inc. July 1998 - December 2000
The Woolf Group, Inc. (GlaxoWellcome) November 1997 - July 1998
ClinTrials Research, Inc. July 1996 - November 1997
Laboratory of Neuropharmacology, NIEHS September 1995 - July 1996
Skills
Biotechnology, Infectious Diseases, Pharmaceutical Industry, GCP, CTMS, Clinical Development, Clinical Research, Clinical Monitoring, Clinical Trials, ICH-GCP, CRO, Regulatory Submissions, Drug Development, Sop, Protocol, IND, Software Documentation, Drug Discovery
Education
East Carolina University
Doctor of Philosophy; Bachelor of Science, Neurobiology
Ela (Elzbieta) McElroy, MBA Ela (Elzbieta) McElroy, MBA's ClinTrials Research Inc, Experience 1992 - 1998
Job Program/Project/Data Management | Strategic Alliance Management | co ViceChair, Programs at WIB RTP Chapter
Industry Pharmaceuticals
Experience
Women In Bio June 2014 - Present
Women In Bio February 2013 - June 2014
PharmaNet/i3 November 2005 - November 2012
Health Decisions June 2005 - November 2005
Ockham Development Group February 2003 - July 2005
QUIK Computing September 2002 - February 2003
INC Research April 2002 - August 2002
Duke Clinical Research Institute December 1999 - April 2002
PAREXEL July 1998 - December 1999
ClinTrials Research, Inc. 1992 - 1998
Skills
Clinical Data Management, Clinical Research, CRO, Project Management, EDC, Customer-focused, Strategic Planning, Multi-national..., Cross-cultural, RFPs, GCPs, Process Improvement, Forecasting, Feasibility Studies, Planning Budgeting &..., SAS, Data Analysis, GCP, Training, Program Management, Management, Pharmaceutical Industry, Clinical Trials
Education
North Carolina State University
Master of Business Administration (MBA), Finance, General
North Carolina State University
Bachelor of Arts (BA), Business, Management, Marketing, Feasibility Research
Women In Bio June 2014 - Present
Women In Bio February 2013 - June 2014
PharmaNet/i3 November 2005 - November 2012
Health Decisions June 2005 - November 2005
Ockham Development Group February 2003 - July 2005
QUIK Computing September 2002 - February 2003
INC Research April 2002 - August 2002
Duke Clinical Research Institute December 1999 - April 2002
PAREXEL July 1998 - December 1999
ClinTrials Research, Inc. 1992 - 1998
Skills
Clinical Data Management, Clinical Research, CRO, Project Management, EDC, Customer-focused, Strategic Planning, Multi-national..., Cross-cultural, RFPs, GCPs, Process Improvement, Forecasting, Feasibility Studies, Planning Budgeting &..., SAS, Data Analysis, GCP, Training, Program Management, Management, Pharmaceutical Industry, Clinical Trials
Education
North Carolina State University
Master of Business Administration (MBA), Finance, General
North Carolina State University
Bachelor of Arts (BA), Business, Management, Marketing, Feasibility Research
Joe Garefino Joe Garefino's ClinTrials Research Inc, Experience February 1994 - January 1995
Job President at J Garefino Consulting LLC
Industry Pharmaceuticals
Experience
J GAREFINO CONSULTING, LLC March 2006 - Present
JMG CLINICAL RESEARCH INC January 1996 - May 2006
JMG CLINICAL RESEARCH, INC. January 1995 - May 2006
CLINTRIALS RESEARCH INC February 1994 - January 1995
CEPHALON INC September 1993 - February 1994
PACT, INC July 1991 - September 1993
Pact, Inc. July 1991 - July 1992
Johnson & Johnson Family of Companies November 1983 - July 1991
Skills
Data Management, Quality Control, Clinical Monitoring, Quality Assurance, Auditing, Project Management, Operations Management, Recruiting, Budgets, Clinical Trials, Cross-functional Team..., Oncology, Medical Devices, Pharmaceutical Industry, CRO, Biotechnology, Clinical Development, CTMS, EDC, Pharmacovigilance, Pharmaceutics, Regulatory Submissions, Drug Development, Regulatory Affairs, 21 CFR Part 11, FDA, Infectious Diseases, Medical Writing, Clinical Research, Diabetes, Sop, Lifesciences, Cardiology, Neurology, Vaccines, Dermatology, Biopharmaceuticals, Regulatory Requirements, Immunology, Commercialization, GCP
Education
Trenton State College 1985 — 1987
M.Ed, Health Management
Rutgers University-New Brunswick 1978 — 1983
BS, Physical Education-Pre Med
J GAREFINO CONSULTING, LLC March 2006 - Present
JMG CLINICAL RESEARCH INC January 1996 - May 2006
JMG CLINICAL RESEARCH, INC. January 1995 - May 2006
CLINTRIALS RESEARCH INC February 1994 - January 1995
CEPHALON INC September 1993 - February 1994
PACT, INC July 1991 - September 1993
Pact, Inc. July 1991 - July 1992
Johnson & Johnson Family of Companies November 1983 - July 1991
Skills
Data Management, Quality Control, Clinical Monitoring, Quality Assurance, Auditing, Project Management, Operations Management, Recruiting, Budgets, Clinical Trials, Cross-functional Team..., Oncology, Medical Devices, Pharmaceutical Industry, CRO, Biotechnology, Clinical Development, CTMS, EDC, Pharmacovigilance, Pharmaceutics, Regulatory Submissions, Drug Development, Regulatory Affairs, 21 CFR Part 11, FDA, Infectious Diseases, Medical Writing, Clinical Research, Diabetes, Sop, Lifesciences, Cardiology, Neurology, Vaccines, Dermatology, Biopharmaceuticals, Regulatory Requirements, Immunology, Commercialization, GCP
Education
Trenton State College 1985 — 1987
M.Ed, Health Management
Rutgers University-New Brunswick 1978 — 1983
BS, Physical Education-Pre Med
Angela Rice-Warren Angela Rice-Warren's ClinTrials Research Inc, Experience July 1994 - August 1996
Job Accomplished Training and Development Expert ✔ Engaging Instructor & Leader ✔
Industry Professional Training & Coaching
Experience
Duke Private Diagnostic Clinics, LLC June 2015 - Present
Duke Clinical Research Institute November 2009 - May 2015
Duke University July 2008 - October 2009
Duke University Medical Center, CALGB 2001 - 2008
Blue Cross Blue Shield January 2000 - October 2001
Duke Clinical Research Institute September 1996 - December 1999
Clintrials Research Inc July 1994 - August 1996
Golden Corral Corporation March 1990 - July 1994
Skills
Training, Instructional Design, Employee Training, E-Learning, Blended Learning, Adult Education, Management, Public Speaking, Needs Analysis, Technical Training, Performance Management, Distance Learning, Instructor-led Training, Training Delivery, Curriculum Design, ADDIE, Training & Development, Leadership, Leadership Development, Program Management, Clinical Research, Technical Writing, Learning Management, Learning Management..., Employee Engagement, Research, Team Building, Software Documentation, Interviews, Organizational..., Compliance, Project Management, Staff Development, Captivate, Change Management
Education
North Carolina State University 2011 — 2015
Master of Education (MEd), Adult Education, 4.0 GPA
North Carolina State University 2011 — 2013
Graduate Certificate, Training and Development, 4.0 GPA
NCSU 1987 — 1991
Bachelor's degree, Communication/Public Relations
Wake Forest-Rolesville High School 1984 — 1987
Duke Private Diagnostic Clinics, LLC June 2015 - Present
Duke Clinical Research Institute November 2009 - May 2015
Duke University July 2008 - October 2009
Duke University Medical Center, CALGB 2001 - 2008
Blue Cross Blue Shield January 2000 - October 2001
Duke Clinical Research Institute September 1996 - December 1999
Clintrials Research Inc July 1994 - August 1996
Golden Corral Corporation March 1990 - July 1994
Skills
Training, Instructional Design, Employee Training, E-Learning, Blended Learning, Adult Education, Management, Public Speaking, Needs Analysis, Technical Training, Performance Management, Distance Learning, Instructor-led Training, Training Delivery, Curriculum Design, ADDIE, Training & Development, Leadership, Leadership Development, Program Management, Clinical Research, Technical Writing, Learning Management, Learning Management..., Employee Engagement, Research, Team Building, Software Documentation, Interviews, Organizational..., Compliance, Project Management, Staff Development, Captivate, Change Management
Education
North Carolina State University 2011 — 2015
Master of Education (MEd), Adult Education, 4.0 GPA
North Carolina State University 2011 — 2013
Graduate Certificate, Training and Development, 4.0 GPA
NCSU 1987 — 1991
Bachelor's degree, Communication/Public Relations
Wake Forest-Rolesville High School 1984 — 1987
Jennifer Brogley Jennifer Brogley's ClinTrials Research Inc, Experience January 1994 - January 1995
Job Director, Part C Appeals at CignaHealthSpring
Industry Hospital & Health Care
Experience
Cigna-HealthSpring January 2014 - Present
Cigna-HealthSpring June 2011 - December 2013
Cigna-HealthSpring May 2009 - June 2011
Cigna-HealthSpring December 2006 - May 2009
Cigna-HealthSpring April 2005 - December 2006
Cigna-HealthSpring August 2004 - April 2005
Healthcare Claims Consultants, LLC November 2001 - April 2004
SRN Consultants September 1995 - October 2001
Williamson Medical Center April 1995 - October 1997
Clintrials Research, Inc January 1994 - January 1995
Skills
Employee Training, Medicare, Clinical Research, Case Managment, Managed Care, Policy, Training, Healthcare, Software Documentation, Utilization Management, Process Improvement, Nursing, Quality Improvement, Case Management, Healthcare Management, Physicians, Medicaid, Healthcare Information..., HIPAA
Education
Central Michigan University
Masters, Health Care Administration
Northern Michigan University 1976 — 1980
Bachelor of Science, Nursing
Cigna-HealthSpring January 2014 - Present
Cigna-HealthSpring June 2011 - December 2013
Cigna-HealthSpring May 2009 - June 2011
Cigna-HealthSpring December 2006 - May 2009
Cigna-HealthSpring April 2005 - December 2006
Cigna-HealthSpring August 2004 - April 2005
Healthcare Claims Consultants, LLC November 2001 - April 2004
SRN Consultants September 1995 - October 2001
Williamson Medical Center April 1995 - October 1997
Clintrials Research, Inc January 1994 - January 1995
Skills
Employee Training, Medicare, Clinical Research, Case Managment, Managed Care, Policy, Training, Healthcare, Software Documentation, Utilization Management, Process Improvement, Nursing, Quality Improvement, Case Management, Healthcare Management, Physicians, Medicaid, Healthcare Information..., HIPAA
Education
Central Michigan University
Masters, Health Care Administration
Northern Michigan University 1976 — 1980
Bachelor of Science, Nursing
Kimberly Edgerton's ClinTrials Research Inc, Experience January 1998 - January 2000
Job Regulatory Affairs Manager at Synthon
Industry Pharmaceuticals
Experience
Synthon September 2012 - Present
Aptiv Solutions February 2008 - September 2012
Teleflex Medical January 2005 - February 2008
BIOPHARM RESOURCES FOR KING PHARMACEUTICALS 2004 - 2005
RANDSTAD NORTH AMERICA 2002 - 2004
THE WOOLF GROUP, INC January 2000 - January 2002
CLINTRIALS RESEARCH, INC January 1998 - January 2000
Clintrial research 1998 - 1998
Skills
Regulatory Submissions, FDA, Regulatory Affairs, IND, ISO 13485, Pharmaceutical Industry, Medical Devices, Clinical Development, Biotechnology, Clinical Trials, CRO
Education
North Carolina Central University 1991 — 1994
BA, Political Science/Public Administration
Durham Technical Community College 1987 — 1989
Associate in Applied Science, Paralegal Technology
UNC-Charlotte 1983 — 1985
Bachelor of Science (B.S.), Biology/Biological Sciences, General
Synthon September 2012 - Present
Aptiv Solutions February 2008 - September 2012
Teleflex Medical January 2005 - February 2008
BIOPHARM RESOURCES FOR KING PHARMACEUTICALS 2004 - 2005
RANDSTAD NORTH AMERICA 2002 - 2004
THE WOOLF GROUP, INC January 2000 - January 2002
CLINTRIALS RESEARCH, INC January 1998 - January 2000
Clintrial research 1998 - 1998
Skills
Regulatory Submissions, FDA, Regulatory Affairs, IND, ISO 13485, Pharmaceutical Industry, Medical Devices, Clinical Development, Biotechnology, Clinical Trials, CRO
Education
North Carolina Central University 1991 — 1994
BA, Political Science/Public Administration
Durham Technical Community College 1987 — 1989
Associate in Applied Science, Paralegal Technology
UNC-Charlotte 1983 — 1985
Bachelor of Science (B.S.), Biology/Biological Sciences, General
Ed Buonopane's ClinTrials Research Inc, Experience 1997 - 1998
Job Director of IT at WWHGD
Industry Law Practice
Experience
Weinberg, Wheeler, Hudgins, Gunn & Dial 2002 - Present
Plantation Pipeline 1998 - 2001
Clintrials Research, Inc 1997 - 1998
USPS 1996 - 1997
Alcatel North America 1988 - 1996
Siecor Corp. 1982 - 1988
Skills
Systems Management, Litigation Support, Professional Services, Litigation, SaaS, Cloud Computing, Management, Enterprise Software, Intellectual Property, Document Management, Information Technology, Disaster Recovery, CRM, Document Review, Project Management, Application Performance..., Civil Litigation, Data Center, Leadership, Consulting, Virtualization
Education
Northeastern University 1979 — 1982
BS, EE
Weinberg, Wheeler, Hudgins, Gunn & Dial 2002 - Present
Plantation Pipeline 1998 - 2001
Clintrials Research, Inc 1997 - 1998
USPS 1996 - 1997
Alcatel North America 1988 - 1996
Siecor Corp. 1982 - 1988
Skills
Systems Management, Litigation Support, Professional Services, Litigation, SaaS, Cloud Computing, Management, Enterprise Software, Intellectual Property, Document Management, Information Technology, Disaster Recovery, CRM, Document Review, Project Management, Application Performance..., Civil Litigation, Data Center, Leadership, Consulting, Virtualization
Education
Northeastern University 1979 — 1982
BS, EE
Mercedes Davila-Owens's ClinTrials Research Inc, Experience March 1998 - February 2001
Job Project Director at Medidata Solutions
Industry Pharmaceuticals
Experience
Medidata Solutions April 2006 - Present
Interactive Clinical Technology, Inc. (ICTI) 2001 - 2006
ClinTrials Research, Inc. March 1998 - February 2001
UNC Hospitals July 1996 - March 1998
Detroit Medical Center June 1994 - July 1996
Skills
EDC, CTMS, Clinical Data Management, Clinical Trials, CRO, Clinical Development, Data Management, GCP, Medicine, Pharmaceutical Industry, Software Documentation, Clinical Research, Quality Assurance, Management, FDA
Education
Madonna University 1990 — 1994
BSN, Nursing
Medidata Solutions April 2006 - Present
Interactive Clinical Technology, Inc. (ICTI) 2001 - 2006
ClinTrials Research, Inc. March 1998 - February 2001
UNC Hospitals July 1996 - March 1998
Detroit Medical Center June 1994 - July 1996
Skills
EDC, CTMS, Clinical Data Management, Clinical Trials, CRO, Clinical Development, Data Management, GCP, Medicine, Pharmaceutical Industry, Software Documentation, Clinical Research, Quality Assurance, Management, FDA
Education
Madonna University 1990 — 1994
BSN, Nursing
Danielle Nowak, CCRA's ClinTrials Research Inc, Experience August 1995 - August 1997
Job Regional Monitor at Actelion
Industry Pharmaceuticals
Experience
Actelion April 2010 - Present
Sanofi-Aventis August 1999 - April 2010
MDS Harris August 1997 - August 1999
ClinTrials Research, Inc. August 1995 - August 1997
Barton & Polansky Associates November 1993 - August 1995
Auditrials, Inc. July 1993 - November 1993
George Washington University Medical Center December 1990 - July 1993
Skills
Clinical Trials, CTMS, GCP, ICH-GCP, Clinical Research, Infectious Diseases, Diabetes, Sop, Protocol, Medical Devices, FDA, CRF design, IRB, GMP, Clinical Development, EDC, CRO, Pharmaceutical Industry
Education
Colby College 1985 — 1989
Human Development (Biology & Psychology)
Actelion April 2010 - Present
Sanofi-Aventis August 1999 - April 2010
MDS Harris August 1997 - August 1999
ClinTrials Research, Inc. August 1995 - August 1997
Barton & Polansky Associates November 1993 - August 1995
Auditrials, Inc. July 1993 - November 1993
George Washington University Medical Center December 1990 - July 1993
Skills
Clinical Trials, CTMS, GCP, ICH-GCP, Clinical Research, Infectious Diseases, Diabetes, Sop, Protocol, Medical Devices, FDA, CRF design, IRB, GMP, Clinical Development, EDC, CRO, Pharmaceutical Industry
Education
Colby College 1985 — 1989
Human Development (Biology & Psychology)
Shelley Stanley's ClinTrials Research Inc, Experience 1996 - 1998
Job Senior Manager, Clinical Project Management at US WorldMeds
Industry Pharmaceuticals
Experience
US WorldMeds 2015 - Present
US WorldMeds 2014 - 2015
Biopharmaceutical Industry 2013 - 2014
International Network for Outcomes Research (INOR™) 2012 - 2013
HealthCore (a WellPoint company) 2005 - 2012
REGISTRAT, Inc. 1998 - 2005
ClinTrials Research, Inc. 1996 - 1998
Skills
Lifesciences, Clinical Research, Project Management, Strategy, Clinical Trials, Pharmaceutical Industry, Outcomes Research, Clinical Development, Observational Studies, Vendor Management, Management, Contract Negotiation, Comparative..., CRO, Drug Development, GCP, CTMS, Clinical Data Management, Infectious Diseases, Oncology, Health Economics, Clinical Study Design
Education
University of Kentucky
Master's degree, Clinical Nutrition/Nutritionist
US WorldMeds 2015 - Present
US WorldMeds 2014 - 2015
Biopharmaceutical Industry 2013 - 2014
International Network for Outcomes Research (INOR™) 2012 - 2013
HealthCore (a WellPoint company) 2005 - 2012
REGISTRAT, Inc. 1998 - 2005
ClinTrials Research, Inc. 1996 - 1998
Skills
Lifesciences, Clinical Research, Project Management, Strategy, Clinical Trials, Pharmaceutical Industry, Outcomes Research, Clinical Development, Observational Studies, Vendor Management, Management, Contract Negotiation, Comparative..., CRO, Drug Development, GCP, CTMS, Clinical Data Management, Infectious Diseases, Oncology, Health Economics, Clinical Study Design
Education
University of Kentucky
Master's degree, Clinical Nutrition/Nutritionist
Pat Spampinato's ClinTrials Research Inc, Experience 1994 - 1996
Job Virtual CIO and IT Infrastructure Engineer
Industry Biotechnology
Experience
Spampinato Consulting September 2009 - Present
Southern Diagnostic Laboratories September 2009 - March 2010
LipoScience June 2001 - September 2009
Teradata 2000 - 2001
IVIS International 1999 - 2000
Insite Clinical Trials 1996 - 1999
Clintrials Research Inc 1994 - 1996
Nichols Institute Diagnostics 1992 - 1994
Western Digital 1987 - 1992
Skills
Software Documentation, SDLC, Business Analysis, Microsoft SQL Server, SharePoint, PMP, Management, Project Management, SaaS, Security, SQL, Software Development, CRM, Vendor Management, Leadership, Information Technology, Networking, Strategy, Cross-functional Team..., Cloud Computing, Integration, Data Center, Disaster Recovery, Virtualization, Infrastructure, VPN, Process Improvement, Enterprise Software, Program Management, IT Strategy, Troubleshooting, Team Buildingq, Business Intelligence, Information Security
Education
UNC Chapel Hill 2010 — 2011
CGCIO, School Of Government
Mt. San Antonio College 1985 — 1986
Computer Information Systems
California State University-Fullerton
Computer Science
Irvine Valley College
CIS
University of Phoenix
Busines / E-Business
Spampinato Consulting September 2009 - Present
Southern Diagnostic Laboratories September 2009 - March 2010
LipoScience June 2001 - September 2009
Teradata 2000 - 2001
IVIS International 1999 - 2000
Insite Clinical Trials 1996 - 1999
Clintrials Research Inc 1994 - 1996
Nichols Institute Diagnostics 1992 - 1994
Western Digital 1987 - 1992
Skills
Software Documentation, SDLC, Business Analysis, Microsoft SQL Server, SharePoint, PMP, Management, Project Management, SaaS, Security, SQL, Software Development, CRM, Vendor Management, Leadership, Information Technology, Networking, Strategy, Cross-functional Team..., Cloud Computing, Integration, Data Center, Disaster Recovery, Virtualization, Infrastructure, VPN, Process Improvement, Enterprise Software, Program Management, IT Strategy, Troubleshooting, Team Buildingq, Business Intelligence, Information Security
Education
UNC Chapel Hill 2010 — 2011
CGCIO, School Of Government
Mt. San Antonio College 1985 — 1986
Computer Information Systems
California State University-Fullerton
Computer Science
Irvine Valley College
CIS
University of Phoenix
Busines / E-Business
Shannon Villiers's ClinTrials Research Inc, Experience 1996 - 2000
Job Director, DM at Chiltern
Industry Pharmaceuticals
Experience
Chiltern July 2014 - Present
Ockham June 2008 - July 2014
Kendle International August 2006 - May 2008
Charles River Laboratories / Inveresk Research 2000 - 2006
ClinTrials Research, Inc 1996 - 2000
Boehringer Ingelheim Pharmaceuticals December 1990 - October 1996
Education
LaSalle University
MSBM, Business Management
University of Connecticut 1986 — 1990
Chiltern July 2014 - Present
Ockham June 2008 - July 2014
Kendle International August 2006 - May 2008
Charles River Laboratories / Inveresk Research 2000 - 2006
ClinTrials Research, Inc 1996 - 2000
Boehringer Ingelheim Pharmaceuticals December 1990 - October 1996
Education
LaSalle University
MSBM, Business Management
University of Connecticut 1986 — 1990
Glen Brushart's ClinTrials Research Inc, Experience May 1995 - April 1996
Job Clinical Research Consultant at Brushart Research Solutions LLC
Industry Research
Experience
Brushart Research January 2000 - Present
PAREXEL 2012 - 2013
Boston Scientific 2008 - 2011
Omnicare 2000 - 2008
Berlex Biosciences 2003 - 2006
Ilex Oncology Services, Inc April 1998 - December 1999
Covance / Corning Besselaar April 1996 - April 1998
ClinTrials Research, Inc May 1995 - April 1996
Ohio office of the State Auditor December 1993 - May 1995
US Army Reserve October 1986 - April 1995
Skills
Clinical Research, Sop, CTMS, Clinical Trials, Protocol, Training, Clinical Monitoring, GCP, CRO, Clinical Development, EDC, Oncology, Pharmaceutical Industry, Regulatory Submissions, Infectious Diseases, Cardiology, Therapeutic Areas, Neurology, Medical Writing, ICH-GCP, FDA, Clinical Operations, Drug Development, SOP
Education
Ohio University 1988 — 1993
Bachelor of Science (BS), Hearing and Speech Therapy
Ohio University College of Health and Human Services 1988 — 1993
Bachelor of Science Degree, Hearing and Speech Sciences
Ohio University College of Health and Human Services 1988 — 1993
Certificate of Gerontology, Gerontology
Brushart Research January 2000 - Present
PAREXEL 2012 - 2013
Boston Scientific 2008 - 2011
Omnicare 2000 - 2008
Berlex Biosciences 2003 - 2006
Ilex Oncology Services, Inc April 1998 - December 1999
Covance / Corning Besselaar April 1996 - April 1998
ClinTrials Research, Inc May 1995 - April 1996
Ohio office of the State Auditor December 1993 - May 1995
US Army Reserve October 1986 - April 1995
Skills
Clinical Research, Sop, CTMS, Clinical Trials, Protocol, Training, Clinical Monitoring, GCP, CRO, Clinical Development, EDC, Oncology, Pharmaceutical Industry, Regulatory Submissions, Infectious Diseases, Cardiology, Therapeutic Areas, Neurology, Medical Writing, ICH-GCP, FDA, Clinical Operations, Drug Development, SOP
Education
Ohio University 1988 — 1993
Bachelor of Science (BS), Hearing and Speech Therapy
Ohio University College of Health and Human Services 1988 — 1993
Bachelor of Science Degree, Hearing and Speech Sciences
Ohio University College of Health and Human Services 1988 — 1993
Certificate of Gerontology, Gerontology
Stephanie Wood-Louder's ClinTrials Research Inc, Experience 1993 - 1995
Job Experienced Compliance / Finance Manager
Industry Telecommunications
Experience
Sprint Nextel Corp 1996 - 2009
Home Technology Healthcare 1995 - 1996
ClinTrials Research Inc 1993 - 1995
Walmart.com 1991 - 1993
Skills
SOX, Budgeting, Auditing, Forecasting, Compliance, Inventory Management, Accounts Payable, Audit, General Ledger, Accounting, Process Improvement, Financial Analysis, Financial Reporting, Data Analysis, Strategic Planning, Telecommunications, Planning, Excel, Internal Audit, Mergers, Problem Solving, Team Leadership, Program Management, Business Analysis, Internal Controls, Budget Management, Retail, Business Process..., Operations Management, Documentation, Team Building, Policy, Consolidation, Sarbanes-Oxley Act, Budgets, Finance, Risk Management, Leadership, Change Management, Training, Sales Operations, Cross-functional Team..., Variance Analysis, Sales, Human Resources, Financial Modeling, P&L
Education
Middle Tennessee State University 1995 — 1997
MS, Accounting/CIS
Mississippi State University - College of Business and Industry 1987 — 1991
BPA, Accounting
Sprint Nextel Corp 1996 - 2009
Home Technology Healthcare 1995 - 1996
ClinTrials Research Inc 1993 - 1995
Walmart.com 1991 - 1993
Skills
SOX, Budgeting, Auditing, Forecasting, Compliance, Inventory Management, Accounts Payable, Audit, General Ledger, Accounting, Process Improvement, Financial Analysis, Financial Reporting, Data Analysis, Strategic Planning, Telecommunications, Planning, Excel, Internal Audit, Mergers, Problem Solving, Team Leadership, Program Management, Business Analysis, Internal Controls, Budget Management, Retail, Business Process..., Operations Management, Documentation, Team Building, Policy, Consolidation, Sarbanes-Oxley Act, Budgets, Finance, Risk Management, Leadership, Change Management, Training, Sales Operations, Cross-functional Team..., Variance Analysis, Sales, Human Resources, Financial Modeling, P&L
Education
Middle Tennessee State University 1995 — 1997
MS, Accounting/CIS
Mississippi State University - College of Business and Industry 1987 — 1991
BPA, Accounting
Kimberly New's ClinTrials Research Inc, Experience July 1987 - April 1998
Job Director, Clinical Operations UsWorldMeds, LLC
Industry Pharmaceuticals
Experience
UsWorldMeds, LLC April 2014 - Present
US WorldMeds January 2013 - April 2014
Pharm-Olam International May 2012 - January 2013
Pharm-Olam International July 2011 - May 2012
StatWorks Incorporated January 2010 - July 2011
Ikano Therapeutics, Inc. April 2002 - January 2010
University of Kentucky, College of Pharmacy March 2001 - April 2002
REGISTRAT, Inc. 1998 - 2001
ClinTrials Research, Inc. July 1987 - April 1998
ClinTrials Research, Inc. 1994 - 1998
Skills
Clinical Data Management, Clinical Operations, CRO, Clinical Trials, Clinical Research, CTMS, EDC, Pharmaceutical Industry, Drug Development, FDA, Clinical Development, ICH-GCP, Sop, GCP, Clinical Monitoring, Regulatory Submissions, Therapeutic Areas, Protocol, 21 CFR Part 11, Regulatory Affairs, Pharmacovigilance, Neurology, Clinical Study Design, Data Management, Regulatory Requirements, Biostatistics, IND, SAS
Education
Eastern Kentucky University
Bachelors of Science, Statistics
Eastern Kentucky University
Bachelors of Science, Mathematics
University of Kentucky
Associate, Science
UsWorldMeds, LLC April 2014 - Present
US WorldMeds January 2013 - April 2014
Pharm-Olam International May 2012 - January 2013
Pharm-Olam International July 2011 - May 2012
StatWorks Incorporated January 2010 - July 2011
Ikano Therapeutics, Inc. April 2002 - January 2010
University of Kentucky, College of Pharmacy March 2001 - April 2002
REGISTRAT, Inc. 1998 - 2001
ClinTrials Research, Inc. July 1987 - April 1998
ClinTrials Research, Inc. 1994 - 1998
Skills
Clinical Data Management, Clinical Operations, CRO, Clinical Trials, Clinical Research, CTMS, EDC, Pharmaceutical Industry, Drug Development, FDA, Clinical Development, ICH-GCP, Sop, GCP, Clinical Monitoring, Regulatory Submissions, Therapeutic Areas, Protocol, 21 CFR Part 11, Regulatory Affairs, Pharmacovigilance, Neurology, Clinical Study Design, Data Management, Regulatory Requirements, Biostatistics, IND, SAS
Education
Eastern Kentucky University
Bachelors of Science, Statistics
Eastern Kentucky University
Bachelors of Science, Mathematics
University of Kentucky
Associate, Science
Cindy Haynes's ClinTrials Research Inc, Experience June 1992 - December 1996
Job Data Acquisition Manager at GlaxoSmithKline
Industry Pharmaceuticals
Experience
GlaxoSmithKline October 2002 - Present
ClinForce / GlaxoWellcome January 1997 - October 2002
Clintrials Research, Inc. June 1992 - December 1996
Skills
Clinical Trials, Data Analysis, Data Management, EDC, SAS, Databases
Education
North Carolina State University
Bachelor of Science, Agricultural Business Management
North Carolina State University
Bachelor of Science, Animal Science
GlaxoSmithKline October 2002 - Present
ClinForce / GlaxoWellcome January 1997 - October 2002
Clintrials Research, Inc. June 1992 - December 1996
Skills
Clinical Trials, Data Analysis, Data Management, EDC, SAS, Databases
Education
North Carolina State University
Bachelor of Science, Agricultural Business Management
North Carolina State University
Bachelor of Science, Animal Science
Davina Touchton's ClinTrials Research Inc, Experience 1989 - 1991
Job Senior Director, Clinical Site Monitoring at Quintiles
Industry Research
Experience
Quintiles 1991 - Present
Clintrials Research, Inc 1989 - 1991
Skills
GCP, CRO, Clinical Trials, EDC, CTMS, Clinical Development, Clinical Monitoring, ICH-GCP, Clinical Research, Clinical Data Management, Therapeutic Areas, Clinical Operations, Regulatory Submissions, Pharmaceutical Industry, Oncology, Biotechnology, Management, Regulatory Affairs, SOP, Drug Development, FDA, Life Sciences, Pharmacovigilance, Protocol, Leadership, Diabetes, Data Management, Neurology
Education
Meredith College
BA, Social Work
Quintiles 1991 - Present
Clintrials Research, Inc 1989 - 1991
Skills
GCP, CRO, Clinical Trials, EDC, CTMS, Clinical Development, Clinical Monitoring, ICH-GCP, Clinical Research, Clinical Data Management, Therapeutic Areas, Clinical Operations, Regulatory Submissions, Pharmaceutical Industry, Oncology, Biotechnology, Management, Regulatory Affairs, SOP, Drug Development, FDA, Life Sciences, Pharmacovigilance, Protocol, Leadership, Diabetes, Data Management, Neurology
Education
Meredith College
BA, Social Work
Phyllis Smetana's ClinTrials Research Inc, Experience 1996 - 1999
Job Associate Director, Global Statistical Programming at UCB Pharma
Industry Pharmaceuticals
Experience
UCB Pharma 2011 - Present
Schwarz Biosciences (a member of the UCB Group) 2007 - May 2011
Schwarz Biosciences 2004 - 2007
Inveresk Research 1999 - 2004
ClinTrials Research Inc 1996 - 1999
Radian International 1987 - 1996
Skills
CDISC, Statistical Programming, SDTM, Drug Development, Biotechnology, Statistics, NDA, Electronic Submissions, CRO, Clinical Trials, SAS programming, Clinical Data Management, Pharmaceutical Industry, SAS, Regulatory Submissions, Clinical Development, Biostatistics, EDC
Education
University of Warwick 1989 — 1990
Postgraduate Diploma, Statistics
Meredith College 1983 — 1987
BS / BA, Mathematics / Chemistry, French
UCB Pharma 2011 - Present
Schwarz Biosciences (a member of the UCB Group) 2007 - May 2011
Schwarz Biosciences 2004 - 2007
Inveresk Research 1999 - 2004
ClinTrials Research Inc 1996 - 1999
Radian International 1987 - 1996
Skills
CDISC, Statistical Programming, SDTM, Drug Development, Biotechnology, Statistics, NDA, Electronic Submissions, CRO, Clinical Trials, SAS programming, Clinical Data Management, Pharmaceutical Industry, SAS, Regulatory Submissions, Clinical Development, Biostatistics, EDC
Education
University of Warwick 1989 — 1990
Postgraduate Diploma, Statistics
Meredith College 1983 — 1987
BS / BA, Mathematics / Chemistry, French
Sue Avery's ClinTrials Research Inc, Experience September 1994 - October 1996
Job Clinical Research Education and Training
Industry Research
Experience
Duke Translational Medicine Institute (DTMI) May 2007 - December 2013
Duke Clinical Research Institute April 2005 - April 2007
Duke Clinical Research Institute March 2002 - March 2005
The Cornerstone Institute October 1999 - February 2002
Independent Consulting and Training in Clinical Research November 1998 - October 1999
InSite Clinical trials October 1996 - November 1998
InSite Clinical Trials October 1996 - November 1998
ClinTrials Research, Inc. September 1994 - October 1996
ClinTrials Research, Inc. September 1993 - September 1994
ClinTrials Research, Inc. September 1992 - September 1993
Skills
Clinical Trials, Leadership Development
Education
Buffalo General School of Nursing
Diploma, Nursing
State University of New York @ Buffalo
Bachelor's Degree, Nursing
Duke University
Master's Degree, Nursing Administration
Duke Translational Medicine Institute (DTMI) May 2007 - December 2013
Duke Clinical Research Institute April 2005 - April 2007
Duke Clinical Research Institute March 2002 - March 2005
The Cornerstone Institute October 1999 - February 2002
Independent Consulting and Training in Clinical Research November 1998 - October 1999
InSite Clinical trials October 1996 - November 1998
InSite Clinical Trials October 1996 - November 1998
ClinTrials Research, Inc. September 1994 - October 1996
ClinTrials Research, Inc. September 1993 - September 1994
ClinTrials Research, Inc. September 1992 - September 1993
Skills
Clinical Trials, Leadership Development
Education
Buffalo General School of Nursing
Diploma, Nursing
State University of New York @ Buffalo
Bachelor's Degree, Nursing
Duke University
Master's Degree, Nursing Administration
Josie Cruz-Jain's ClinTrials Research Inc, Experience 1996 - 1997
Job Independent Clinical Research/Regulatory Writer
Industry Pharmaceuticals
Experience
TargeGen, Inc. 2007 - 2009
Elan Pharmaceuticals, Inc 2003 - 2006
Alliance Pharmaceutical Corp. 2001 - 2002
Alliance Pharmaceutical Corp. 1998 - 2001
Isis Pharmaceuticals 1997 - 1998
ClinTrials Research, Inc. 1996 - 1997
Chiron Vision 1994 - 1995
IOLAB Corporation 1992 - 1994
IOLAB Corporation (formerly a J&J company) 1988 - 1992
Department of Pharmacology, College of Medicine, University of the Philippines 1977 - 1988
Skills
Medical Writing, Regulatory Affairs
Education
Loma Linda University
Earned credit units in pharmacology (PhD/MD program), Pharmacology
University of London
Clinical Pharmacology
University of the Philippines
Doctor of Medicine, Family Medicine, Pharmacology
TargeGen, Inc. 2007 - 2009
Elan Pharmaceuticals, Inc 2003 - 2006
Alliance Pharmaceutical Corp. 2001 - 2002
Alliance Pharmaceutical Corp. 1998 - 2001
Isis Pharmaceuticals 1997 - 1998
ClinTrials Research, Inc. 1996 - 1997
Chiron Vision 1994 - 1995
IOLAB Corporation 1992 - 1994
IOLAB Corporation (formerly a J&J company) 1988 - 1992
Department of Pharmacology, College of Medicine, University of the Philippines 1977 - 1988
Skills
Medical Writing, Regulatory Affairs
Education
Loma Linda University
Earned credit units in pharmacology (PhD/MD program), Pharmacology
University of London
Clinical Pharmacology
University of the Philippines
Doctor of Medicine, Family Medicine, Pharmacology
Christof Jensen's ClinTrials Research Inc, Experience 1995 - 1996
Job VP, Head Global Project Management, UCB BioSciences, Inc.
Industry Pharmaceuticals
Experience
UCB 2015 - Present
UCB 1999 - 2014
UCB 1996 - 1999
Clintrials Research, Inc 1995 - 1996
Boots Pharmaceuticals 1992 - 1995
Skills
Pharmaceutical Industry, Clinical Development, Clinical Trials, Biotechnology, GCP, Drug Development, CRO, Regulatory Affairs, Biopharmaceuticals, Oncology
Education
Fielding Graduate University 2003 — 2006
Master's Degree, Human Development
Northwestern State University 1989 — 1992
Master's Degree, Clinical Psychology / Neuropsychology
UCB 2015 - Present
UCB 1999 - 2014
UCB 1996 - 1999
Clintrials Research, Inc 1995 - 1996
Boots Pharmaceuticals 1992 - 1995
Skills
Pharmaceutical Industry, Clinical Development, Clinical Trials, Biotechnology, GCP, Drug Development, CRO, Regulatory Affairs, Biopharmaceuticals, Oncology
Education
Fielding Graduate University 2003 — 2006
Master's Degree, Human Development
Northwestern State University 1989 — 1992
Master's Degree, Clinical Psychology / Neuropsychology
David Polakovs's ClinTrials Research Inc, Experience March 1988 - June 1998
Job Director, Clinical Outsourcing
Industry Biotechnology
Experience
Onyx Pharmaceuticals November 2014 - Present
Genentech January 2005 - October 2014
i3 Statprobe June 1998 - December 2004
STATPROBE Inc 1998 - 2004
Clintrials Research, Inc March 1988 - June 1998
Skills
Clinical Development, CRO, Oncology, EDC, Therapeutic Areas, Clinical Trials, Biotechnology, Clinical Data Management, Pharmaceutical Industry, GCP, 21 CFR Part 11, FDA, Pharmacovigilance, Sop, Drug Development, Biopharmaceuticals, Lifesciences, Regulatory Submissions, Validation, Regulatory Affairs, IND, SOP, Life Sciences
Education
Eastern Kentucky University 1985 — 1988
BS, Math/Stats
High School
Onyx Pharmaceuticals November 2014 - Present
Genentech January 2005 - October 2014
i3 Statprobe June 1998 - December 2004
STATPROBE Inc 1998 - 2004
Clintrials Research, Inc March 1988 - June 1998
Skills
Clinical Development, CRO, Oncology, EDC, Therapeutic Areas, Clinical Trials, Biotechnology, Clinical Data Management, Pharmaceutical Industry, GCP, 21 CFR Part 11, FDA, Pharmacovigilance, Sop, Drug Development, Biopharmaceuticals, Lifesciences, Regulatory Submissions, Validation, Regulatory Affairs, IND, SOP, Life Sciences
Education
Eastern Kentucky University 1985 — 1988
BS, Math/Stats
High School
Doug Criger's ClinTrials Research Inc, Experience 1991 - 1995
Job Manager, Biostatistics at PPD
Industry Pharmaceuticals
Experience
PPD 2000 - Present
Duke Clinical Research Institute 1996 - 2000
University of North Carolina, School of Nursing 1996 - 1997
ClinTrials Research Inc. 1991 - 1995
Skills
Clinical Trials, Biostatistics, SAS, CRO, Statistics, SAS programming, Statistical Modeling, Clinical Development, Pharmaceutical Industry, Oncology, Infectious Diseases, Clinical Research, Data Analysis, Biotechnology, Protocol, Statistical Programming, SDTM, EDC, SAS Programming
Education
University of North Carolina at Chapel Hill 1992 — 1998
MPH, Biostatistics
Brigham Young University 1983 — 1989
BS, Statistics (minor in mathematics)
PPD 2000 - Present
Duke Clinical Research Institute 1996 - 2000
University of North Carolina, School of Nursing 1996 - 1997
ClinTrials Research Inc. 1991 - 1995
Skills
Clinical Trials, Biostatistics, SAS, CRO, Statistics, SAS programming, Statistical Modeling, Clinical Development, Pharmaceutical Industry, Oncology, Infectious Diseases, Clinical Research, Data Analysis, Biotechnology, Protocol, Statistical Programming, SDTM, EDC, SAS Programming
Education
University of North Carolina at Chapel Hill 1992 — 1998
MPH, Biostatistics
Brigham Young University 1983 — 1989
BS, Statistics (minor in mathematics)
Lynne Howell's ClinTrials Research Inc, Experience July 1993 - November 1993
Job Associate Director, Clinical Research at Merck
Industry Pharmaceuticals
Experience
Merck August 2014 - Present
ReSearch Pharmaceutical Services October 2010 - August 2014
Allergan, Inc. October 2004 - September 2010
Allergan, Inc. January 1999 - October 2004
Chrysalis International (BioClin, Inc.) December 1996 - December 1998
BioClin, Inc. December 1995 - December 1996
BioClin, Inc. November 1993 - December 1995
ClinTrials Research, Inc. July 1993 - November 1993
ClinTrials Research, Inc. December 1990 - July 1993
Veterans Administration Medical Center June 1984 - December 1990
Skills
GCP, Clinical Monitoring, CTMS, EDC, Clinical Trials, CRO, ICH-GCP, Clinical Research, Infectious Diseases, Clinical Operations, Ophthalmology, Pharmaceutical Industry, Dermatology, Cardiology, Neurology, Inform, FDA, Vaccines, Urology, Therapeutic Areas, Endocrinology, Sop, Clinical Data Management, Regulatory Submissions, Clinical Development, Oncology, Regulatory Affairs, Protocol, Pharmacovigilance, Medical Writing, Drug Development, Hematology, Medical Affairs, Patient Recruitment, CRF design, Diabetes, IRB, Clinical Study Design, Oracle Clinical, SOP
Education
Austin Peay State University 1980 — 1984
BSN, Nursing
Merck August 2014 - Present
ReSearch Pharmaceutical Services October 2010 - August 2014
Allergan, Inc. October 2004 - September 2010
Allergan, Inc. January 1999 - October 2004
Chrysalis International (BioClin, Inc.) December 1996 - December 1998
BioClin, Inc. December 1995 - December 1996
BioClin, Inc. November 1993 - December 1995
ClinTrials Research, Inc. July 1993 - November 1993
ClinTrials Research, Inc. December 1990 - July 1993
Veterans Administration Medical Center June 1984 - December 1990
Skills
GCP, Clinical Monitoring, CTMS, EDC, Clinical Trials, CRO, ICH-GCP, Clinical Research, Infectious Diseases, Clinical Operations, Ophthalmology, Pharmaceutical Industry, Dermatology, Cardiology, Neurology, Inform, FDA, Vaccines, Urology, Therapeutic Areas, Endocrinology, Sop, Clinical Data Management, Regulatory Submissions, Clinical Development, Oncology, Regulatory Affairs, Protocol, Pharmacovigilance, Medical Writing, Drug Development, Hematology, Medical Affairs, Patient Recruitment, CRF design, Diabetes, IRB, Clinical Study Design, Oracle Clinical, SOP
Education
Austin Peay State University 1980 — 1984
BSN, Nursing
Carol Dietz's ClinTrials Research Inc, Experience 1992 - 2000
Job Pharmacist with both retail and regulatory experience.
Industry Pharmaceuticals
Experience
Currently seeking new opportunity January 2014 - Present
Harris Teeter Supermarkets August 2000 - December 2013
ClinTrials Research, Inc 1992 - 2000
Rex Healthcare 1990 - 1991
Education
Purdue University 1979 — 1986
Registered Pharmacist, Pharmacy, Pharmaceutical Sciences
Purdue University 1978 — 1986
BS Pharm, Pharmacy
Currently seeking new opportunity January 2014 - Present
Harris Teeter Supermarkets August 2000 - December 2013
ClinTrials Research, Inc 1992 - 2000
Rex Healthcare 1990 - 1991
Education
Purdue University 1979 — 1986
Registered Pharmacist, Pharmacy, Pharmaceutical Sciences
Purdue University 1978 — 1986
BS Pharm, Pharmacy
Edwin Archbold's ClinTrials Research Inc, Experience 1993 - 1995
Job Sr. Clinical Research Associate at INC Research
Industry Pharmaceuticals
Experience
INC Research February 2014 - Present
Quantum Clinical, LLC July 2013 - Present
ReSearch Pharmaceutical Services October 2012 - December 2013
Alcon Research, Ltd. July 2010 - October 2012
Forest Laboratories August 2002 - July 2010
TKL Research, Inc. 2001 - 2002
Amgen 1999 - 2001
Kendle International Inc. 1998 - 1999
Clintrials Research, Inc. 1993 - 1995
Pan American Health Organization 1989 - 1993
Skills
CTMS, Clinical Research, Clinical Trials, EDC, GCP, Pharmaceutical Industry, ICH-GCP, Regulatory Submissions, Cross-functional Team..., CRO, Infectious Diseases, Clinical Monitoring, Clinical Development, Therapeutic Areas, Medidata CTMS, IVRS/IWRS, Oncology, Neurology
Education
University of California, Riverside 1981 — 1986
PhD, Entomology
Loma Linda University 1978 — 1980
MA, Biology
Universidad de Montemorelos 1974 — 1978
BA, Pedagogia--Biologia y Quimica
Instituto Vocacional de Venezuela, Nirgua 1970 — 1973
HS, NA
INC Research February 2014 - Present
Quantum Clinical, LLC July 2013 - Present
ReSearch Pharmaceutical Services October 2012 - December 2013
Alcon Research, Ltd. July 2010 - October 2012
Forest Laboratories August 2002 - July 2010
TKL Research, Inc. 2001 - 2002
Amgen 1999 - 2001
Kendle International Inc. 1998 - 1999
Clintrials Research, Inc. 1993 - 1995
Pan American Health Organization 1989 - 1993
Skills
CTMS, Clinical Research, Clinical Trials, EDC, GCP, Pharmaceutical Industry, ICH-GCP, Regulatory Submissions, Cross-functional Team..., CRO, Infectious Diseases, Clinical Monitoring, Clinical Development, Therapeutic Areas, Medidata CTMS, IVRS/IWRS, Oncology, Neurology
Education
University of California, Riverside 1981 — 1986
PhD, Entomology
Loma Linda University 1978 — 1980
MA, Biology
Universidad de Montemorelos 1974 — 1978
BA, Pedagogia--Biologia y Quimica
Instituto Vocacional de Venezuela, Nirgua 1970 — 1973
HS, NA
Valentin-Razvan Curt's ClinTrials Research Inc, Experience April 1996 - August 1999
Job Senior Director at Daiichi Sankyo
Industry Pharmaceuticals
Experience
Daiichi Sankyo June 2011 - Present
Novartis October 2006 - June 2011
Boehringer Ingelheim Pharmaceuticals February 2003 - October 2006
Tanox, Inc. February 2001 - December 2002
Aronex Pharmaceuticals August 1999 - January 2001
ClinTrials Research Inc. April 1996 - August 1999
Skills
Drug Development, Clinical Trials, Clinical Development, Oncology, Infectious Diseases, CRO, Medical Affairs, Therapeutic Areas, Immunology, Regulatory Submissions, Clinical Research, Protocol, Hematology, Endocrinology, Drug Safety, Clinical Operations, Clinical Study Design, CTMS, Clinical Monitoring, Pharmaceutical Industry, FDA, Lifesciences, Biotechnology, Pharmacovigilance, Medicine, ICH-GCP, GCP, Medical Writing, Hypertension, IND
Education
1985 — 1991
M.D., General Medicine
Daiichi Sankyo June 2011 - Present
Novartis October 2006 - June 2011
Boehringer Ingelheim Pharmaceuticals February 2003 - October 2006
Tanox, Inc. February 2001 - December 2002
Aronex Pharmaceuticals August 1999 - January 2001
ClinTrials Research Inc. April 1996 - August 1999
Skills
Drug Development, Clinical Trials, Clinical Development, Oncology, Infectious Diseases, CRO, Medical Affairs, Therapeutic Areas, Immunology, Regulatory Submissions, Clinical Research, Protocol, Hematology, Endocrinology, Drug Safety, Clinical Operations, Clinical Study Design, CTMS, Clinical Monitoring, Pharmaceutical Industry, FDA, Lifesciences, Biotechnology, Pharmacovigilance, Medicine, ICH-GCP, GCP, Medical Writing, Hypertension, IND
Education
1985 — 1991
M.D., General Medicine
Kannane Chilongo's ClinTrials Research Inc, Experience 1996 - 1997
Job Clinical Research Specialist
Industry Pharmaceuticals
Experience
Talecris Biotherapeutics, Inc. April 2011 - August 2011
Independent Pharmaceutical Consultant 2003 - 2009
Covance 1999 - 2003
Duke Clinical Research Institute 1998 - 1999
Bristol-Myers Squibb 1997 - 1998
Clintrials Research Inc. 1996 - 1997
Rangos Research 1994 - 1996
Centerville Medical Center 1990 - 1994
Rancho Medical Center 1983 - 1990
Skills
Clinical Research, Pharmacovigilance, Research Project..., Clinical Operations, Drug Safety
Education
University of Pittsburgh 1992 — 1993
Continuing Credits, HIV/AIDS
Universidad Autónoma de Guadalajara 1973 — 1980
M.D., General Medicine
Loma Linda University 1968 — 1972
Bachelors, Biology, Chemistry
Talecris Biotherapeutics, Inc. April 2011 - August 2011
Independent Pharmaceutical Consultant 2003 - 2009
Covance 1999 - 2003
Duke Clinical Research Institute 1998 - 1999
Bristol-Myers Squibb 1997 - 1998
Clintrials Research Inc. 1996 - 1997
Rangos Research 1994 - 1996
Centerville Medical Center 1990 - 1994
Rancho Medical Center 1983 - 1990
Skills
Clinical Research, Pharmacovigilance, Research Project..., Clinical Operations, Drug Safety
Education
University of Pittsburgh 1992 — 1993
Continuing Credits, HIV/AIDS
Universidad Autónoma de Guadalajara 1973 — 1980
M.D., General Medicine
Loma Linda University 1968 — 1972
Bachelors, Biology, Chemistry
Colleen Flynn, Ph.D.'s ClinTrials Research Inc, Experience January 1994 - January 1997
Job Business Development Professional
Industry Biotechnology
Experience
Novella Clinical, Inc January 2005 - April 2013
Clinical Research Networks January 2000 - December 2004
Flynn Consulting January 1998 - January 2000
Integrated Neuroscience Consortium, Neuroclinical Trials Center January 1997 - January 1998
ClinTrials Research, Inc January 1994 - January 1997
Flynn Consulting January 1991 - January 1994
ALZA Corporation January 1988 - January 1990
Stanford Savings & Loan Association January 1986 - January 1987
Stanford Savings & Loan Association January 1983 - January 1987
Education
Stanford University
M.S, Physiology
Stanford University
Ph.D, Physiology
University of Colorado
B, A, Behavioral Biology
Novella Clinical, Inc January 2005 - April 2013
Clinical Research Networks January 2000 - December 2004
Flynn Consulting January 1998 - January 2000
Integrated Neuroscience Consortium, Neuroclinical Trials Center January 1997 - January 1998
ClinTrials Research, Inc January 1994 - January 1997
Flynn Consulting January 1991 - January 1994
ALZA Corporation January 1988 - January 1990
Stanford Savings & Loan Association January 1986 - January 1987
Stanford Savings & Loan Association January 1983 - January 1987
Education
Stanford University
M.S, Physiology
Stanford University
Ph.D, Physiology
University of Colorado
B, A, Behavioral Biology
Myra Herrle's ClinTrials Research Inc, Experience March 1995 - June 1996
Job Regulatory Therapeutic Area Head US & Canada &Affiliates
Industry Pharmaceuticals
Experience
AbbVie August 2014 - Present
Novartis Pharmaceuticals August 2012 - August 2014
Novartis October 2010 - August 2012
Novartis July 2008 - September 2010
Novartis December 2007 - July 2008
Novartis May 2005 - December 2007
GlaxoSmithKline May 2001 - January 2005
GlaxoSmithKline June 1996 - May 2001
ClinTrials Research Inc, March 1995 - June 1996
East Carolina University School of Medicine 1994 - 1994
Skills
Co-development, Medical Devices, Orphan Drugs, Biosimilars, Biologics, Molecular Biology, Pharmacogenetics, Biomarker Development, Oncology, Respiratory Products, Bioequivalence, Dry Powder Inhalers, Infectious Diseases, Autoimmune Diseases, Allergy, Food Allergies, CMC Regulatory Affairs, Protocol Design, Data Analysis, CRF design, FDA, MHRA, Drug Development, IVD, NDA, IND, CTAs, Clinical Research, Clinical Monitoring, Regulatory Agencies, Regulatory Guidelines, Latin America, Clinical Development, GCP
Education
University of Oklahoma Health Sciences Center 1982 — 1987
PhD, Microbiology and Immunology
University of Puerto Rico School of Medicine 1977 — 1982
BS, Pharmacy
AbbVie August 2014 - Present
Novartis Pharmaceuticals August 2012 - August 2014
Novartis October 2010 - August 2012
Novartis July 2008 - September 2010
Novartis December 2007 - July 2008
Novartis May 2005 - December 2007
GlaxoSmithKline May 2001 - January 2005
GlaxoSmithKline June 1996 - May 2001
ClinTrials Research Inc, March 1995 - June 1996
East Carolina University School of Medicine 1994 - 1994
Skills
Co-development, Medical Devices, Orphan Drugs, Biosimilars, Biologics, Molecular Biology, Pharmacogenetics, Biomarker Development, Oncology, Respiratory Products, Bioequivalence, Dry Powder Inhalers, Infectious Diseases, Autoimmune Diseases, Allergy, Food Allergies, CMC Regulatory Affairs, Protocol Design, Data Analysis, CRF design, FDA, MHRA, Drug Development, IVD, NDA, IND, CTAs, Clinical Research, Clinical Monitoring, Regulatory Agencies, Regulatory Guidelines, Latin America, Clinical Development, GCP
Education
University of Oklahoma Health Sciences Center 1982 — 1987
PhD, Microbiology and Immunology
University of Puerto Rico School of Medicine 1977 — 1982
BS, Pharmacy
Nahir Clinton's ClinTrials Research Inc, Experience September 1993 - 1996
Job Principal Data Manager at Novella Clinical, Inc.
Industry Research
Experience
Novella Clinical, Inc. April 2004 - Present
PAREXEL 1996 - 2004
Clintrials Research, Inc. September 1993 - 1996
Skills
CDISC, EDC, Clinical Data Management, Inform, CRF design, Oracle Clinical, GCP, CTMS, Pharmaceutical Industry, Clinical Trials, CRO, ICH-GCP, Clinical Development, Data Management
Education
University of California, Santa Barbara 1989 — 1993
B.S, Biopsychology
Novella Clinical, Inc. April 2004 - Present
PAREXEL 1996 - 2004
Clintrials Research, Inc. September 1993 - 1996
Skills
CDISC, EDC, Clinical Data Management, Inform, CRF design, Oracle Clinical, GCP, CTMS, Pharmaceutical Industry, Clinical Trials, CRO, ICH-GCP, Clinical Development, Data Management
Education
University of California, Santa Barbara 1989 — 1993
B.S, Biopsychology
Crystal Caudle's ClinTrials Research Inc, Experience February 1994 - December 1994
Job President at CLC Research, Inc.
Industry Pharmaceuticals
Experience
CLC Research, Inc. March 2000 - Present
Resource Solutions, Inc August 1998 - April 2000
CSR Consultants, Inc October 1997 - July 1998
Resource Solutions, Inc December 1994 - October 1997
ClinTrials Research Inc February 1994 - December 1994
Skills
Medical Monitoring, Medical Data Review, Narrative writing, Clinical Research, Phase I, Document Review, Pharmaceutical Industry, Clinical Trials, Medicine, Validation, Medical Writing, Narrative, CRO, Clinical Monitoring, Medical Affairs, Sop, GCP, Protocol, Clinical Development, Clinical Study Design, Infectious Diseases, Regulatory Submissions, Oncology, Pharmaceutics, Neurology, Regulatory Affairs, Immunology, SOP
Education
University of North Carolina at Chapel Hill School of Medicine 1988 — 1992
MD with Honors, Medicine
Salem College 1984 — 1988
BS, Biology, Summa Cum Laude
CLC Research, Inc. March 2000 - Present
Resource Solutions, Inc August 1998 - April 2000
CSR Consultants, Inc October 1997 - July 1998
Resource Solutions, Inc December 1994 - October 1997
ClinTrials Research Inc February 1994 - December 1994
Skills
Medical Monitoring, Medical Data Review, Narrative writing, Clinical Research, Phase I, Document Review, Pharmaceutical Industry, Clinical Trials, Medicine, Validation, Medical Writing, Narrative, CRO, Clinical Monitoring, Medical Affairs, Sop, GCP, Protocol, Clinical Development, Clinical Study Design, Infectious Diseases, Regulatory Submissions, Oncology, Pharmaceutics, Neurology, Regulatory Affairs, Immunology, SOP
Education
University of North Carolina at Chapel Hill School of Medicine 1988 — 1992
MD with Honors, Medicine
Salem College 1984 — 1988
BS, Biology, Summa Cum Laude
Elizabeth Millar, MA, RAC's ClinTrials Research Inc, Experience 1998 - 2000
Job Owner and Principal Medical Writer at Carolina Medical Writers, LLC
Industry Pharmaceuticals
Experience
Carolina Medical Writers, LLC 2009 - Present
UCB 2008 - 2009
Independent Consultant 2005 - 2008
Rho, Inc. 2002 - 2005
Rho, Inc. 2001 - 2002
ClinTrials Research Inc. 1998 - 2000
ClinTrials Research Inc. 1996 - 1998
Nortel Networks 1994 - 1996
Skills
Editing, Medical Writing, Regulatory Submissions, Oncology, Clinical Trials, Clinical Development, Infectious Diseases, Therapeutic Areas, Clinical Research, Drug Development, CRO, Protocol, GCP, Regulatory Affairs, Pharmacovigilance, ICH-GCP, Pharmaceutical Industry, EDC, Neurology
Education
Kent State University
MA
Kent State University
BA
Northeast Ohio Medical University (NEOMED) 1987 — 1988
Carolina Medical Writers, LLC 2009 - Present
UCB 2008 - 2009
Independent Consultant 2005 - 2008
Rho, Inc. 2002 - 2005
Rho, Inc. 2001 - 2002
ClinTrials Research Inc. 1998 - 2000
ClinTrials Research Inc. 1996 - 1998
Nortel Networks 1994 - 1996
Skills
Editing, Medical Writing, Regulatory Submissions, Oncology, Clinical Trials, Clinical Development, Infectious Diseases, Therapeutic Areas, Clinical Research, Drug Development, CRO, Protocol, GCP, Regulatory Affairs, Pharmacovigilance, ICH-GCP, Pharmaceutical Industry, EDC, Neurology
Education
Kent State University
MA
Kent State University
BA
Northeast Ohio Medical University (NEOMED) 1987 — 1988
Patricia Gill's ClinTrials Research Inc, Experience 1993 - 1995
Job Pharmaceuticals Research Consultant
Industry Pharmaceuticals
Experience
Forest Research Institute 2011 - Present
Novartis 2010 - 2011
Novo Nordisk, Inc 2005 - 2010
Kos Pharmaceuticals, Inc 2003 - 2005
Novo Nordisk, Inc 2001 - 2003
Pfizer Pharmaceuticals 2001 - 2002
Eli Lilly and Company 1999 - 2001
Quintiles 1997 - 1999
Innovex 1995 - 1996
ClinTrials Research, Inc 1993 - 1995
Skills
Sop, Microbiology, Training, Clinical Trials, Pharmaceutical Industry, Laboratory, GCP, Regulatory Affairs, FDA, Biotechnology, Oncology, Clinical Research, CTMS, Clinical Development, EDC, CRO, Clinical Monitoring, Infectious Diseases, Lifesciences, ICH-GCP, Therapeutic Areas, Cardiology, Diabetes
Education
Middle Tennessee State University
Masters, Business Administration
Austin Peay State University
Bachelor of Science, Clinical Microbiology
University of Tennessee
Bachelor of Arts, Microbiology
Forest Research Institute 2011 - Present
Novartis 2010 - 2011
Novo Nordisk, Inc 2005 - 2010
Kos Pharmaceuticals, Inc 2003 - 2005
Novo Nordisk, Inc 2001 - 2003
Pfizer Pharmaceuticals 2001 - 2002
Eli Lilly and Company 1999 - 2001
Quintiles 1997 - 1999
Innovex 1995 - 1996
ClinTrials Research, Inc 1993 - 1995
Skills
Sop, Microbiology, Training, Clinical Trials, Pharmaceutical Industry, Laboratory, GCP, Regulatory Affairs, FDA, Biotechnology, Oncology, Clinical Research, CTMS, Clinical Development, EDC, CRO, Clinical Monitoring, Infectious Diseases, Lifesciences, ICH-GCP, Therapeutic Areas, Cardiology, Diabetes
Education
Middle Tennessee State University
Masters, Business Administration
Austin Peay State University
Bachelor of Science, Clinical Microbiology
University of Tennessee
Bachelor of Arts, Microbiology
Christine Chin, PhD's ClinTrials Research Inc, Experience 1998 - 2000
Job Medical Writer
Industry Biotechnology
Experience
Helix Biomedical Writing, LLC 2010 - Present
Gilead Sciences April 2009 - Present
King Pharmaceuticals 2003 - 2009
Nobex Corporation 2001 - 2003
ClinTrials Research Inc. 1998 - 2000
Duke University Medical Center 1996 - 1998
Skills
Clinical Trials, Clinical Study Reports, eCTD, Infectious Diseases, Manuscripts, Medical Writing, Pharmacology, Regulatory Submissions, Protocol, Clinical Study Design, Pharmaceutical Industry, Pharmaceutics, Asthma, Drug Development, Clinical Research, Clinical Pharmacology, Clinical Development, Lifesciences, Manuscript, Medical Affairs
Education
Duke University
PhD, Pharmacology
Helix Biomedical Writing, LLC 2010 - Present
Gilead Sciences April 2009 - Present
King Pharmaceuticals 2003 - 2009
Nobex Corporation 2001 - 2003
ClinTrials Research Inc. 1998 - 2000
Duke University Medical Center 1996 - 1998
Skills
Clinical Trials, Clinical Study Reports, eCTD, Infectious Diseases, Manuscripts, Medical Writing, Pharmacology, Regulatory Submissions, Protocol, Clinical Study Design, Pharmaceutical Industry, Pharmaceutics, Asthma, Drug Development, Clinical Research, Clinical Pharmacology, Clinical Development, Lifesciences, Manuscript, Medical Affairs
Education
Duke University
PhD, Pharmacology
Tiersa Tavana's ClinTrials Research Inc, Experience 1995 - 1996
Job Associate Director of ISSC at Novella Clinical, Inc.
Industry Pharmaceuticals
Experience
Novella Clinical May 2013 - May 2015
Novella Clinical, Inc. August 2012 - April 2013
Independent Contractor-S.O.S. Monitoring Inc. June 2001 - August 2012
The Woolf Group 1996 - 2001
ClinTrials Research, INC 1995 - 1996
ClinTrials Research, Inc. 1993 - 1994
Skills
CRO, EDC, Clinical Trials, CTMS, Program Management, Pharmaceutical Industry, Oncology, Lifesciences, GCP, Data Management, Biotechnology, Cross-functional Team..., Clinical Data Management, Clinical Development, Vendor Management, Regulatory Affairs, Sop, Clinical Research, FDA, Pharmacovigilance
Education
University of North Carolina at Chapel Hill 1986 — 1990
Bachelor of Arts (B.A.), Psychology
Novella Clinical May 2013 - May 2015
Novella Clinical, Inc. August 2012 - April 2013
Independent Contractor-S.O.S. Monitoring Inc. June 2001 - August 2012
The Woolf Group 1996 - 2001
ClinTrials Research, INC 1995 - 1996
ClinTrials Research, Inc. 1993 - 1994
Skills
CRO, EDC, Clinical Trials, CTMS, Program Management, Pharmaceutical Industry, Oncology, Lifesciences, GCP, Data Management, Biotechnology, Cross-functional Team..., Clinical Data Management, Clinical Development, Vendor Management, Regulatory Affairs, Sop, Clinical Research, FDA, Pharmacovigilance
Education
University of North Carolina at Chapel Hill 1986 — 1990
Bachelor of Arts (B.A.), Psychology
Patience Vanderbush's ClinTrials Research Inc, Experience August 1989 - March 1995
Job Medical Writing Consultant, CSR Consultants, Inc.
Industry Writing and Editing
Experience
CSR Consultants, Inc. March 1995 - December 2013
ClinTrials Research, Inc. August 1989 - March 1995
Education
University of North Carolina at Chapel Hill 1987 — 1989
MSPH, Public Health
University of North Carolina at Chapel Hill 1985 — 1987
MA, Journalism
Northwestern University 1978 — 1982
BA, English
CSR Consultants, Inc. March 1995 - December 2013
ClinTrials Research, Inc. August 1989 - March 1995
Education
University of North Carolina at Chapel Hill 1987 — 1989
MSPH, Public Health
University of North Carolina at Chapel Hill 1985 — 1987
MA, Journalism
Northwestern University 1978 — 1982
BA, English
Joy Parris's ClinTrials Research Inc, Experience 1995 - 1997
Job Senior Director at Human Genome Sciences
Industry Pharmaceuticals
Experience
Human Genome Sciences April 2011 - Present
MacroGenics December 2008 - April 2011
Otsuka America Pharmaceutical, Inc. November 1999 - October 2008
Otsuka 1999 - 2008
Quintiles April 1998 - November 1999
Quintiles 1997 - April 1998
ClinTrials Research Inc. 1995 - 1997
Education
University of the West Indies, Mona Campus 1980 — 1986
Doctor of Medicine (MD), Medicine
Brooklyn College 1975 — 1979
BSc, Biology /Biochemistry
St george's College 1964 — 1970
Human Genome Sciences April 2011 - Present
MacroGenics December 2008 - April 2011
Otsuka America Pharmaceutical, Inc. November 1999 - October 2008
Otsuka 1999 - 2008
Quintiles April 1998 - November 1999
Quintiles 1997 - April 1998
ClinTrials Research Inc. 1995 - 1997
Education
University of the West Indies, Mona Campus 1980 — 1986
Doctor of Medicine (MD), Medicine
Brooklyn College 1975 — 1979
BSc, Biology /Biochemistry
St george's College 1964 — 1970
Carole Gabos's ClinTrials Research Inc, Experience 1997 - 1999
Job
Industry
Experience
Novella Clinical, Inc. January 2013 - Present
Paragon Biomedical (Now Clinipace Worldwide) 2009 - 2013
i3 Research 2006 - 2009
Quintiles 1999 - 2000
Clintrials Research, Inc 1997 - 1999
Clintrials Research, Inc 1997 - 1999
Clintrials Research, Inc 1997 - 1999
Education
University of Dayton
Bachelor of Science (B.S.), Social Work/Psychology
Novella Clinical, Inc. January 2013 - Present
Paragon Biomedical (Now Clinipace Worldwide) 2009 - 2013
i3 Research 2006 - 2009
Quintiles 1999 - 2000
Clintrials Research, Inc 1997 - 1999
Clintrials Research, Inc 1997 - 1999
Clintrials Research, Inc 1997 - 1999
Education
University of Dayton
Bachelor of Science (B.S.), Social Work/Psychology