Lineberry Research Associates
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Lineberry Research Associates Employees
Apple October 2014 - Present
Urban Outfitters June 2013 - October 2014
Urban Outfitters January 2012 - June 2013
Abercrombie & Fitch November 2010 - January 2012
Abercrombie & Fitch October 2009 - November 2010
Abercrombie & Fitch July 2007 - October 2009
Skidmore College September 2005 - May 2007
Lineberry Research Associates June 2004 - September 2006
SAS Institute May 2001 - August 2001
Skills
Retail, Merchandising, Customer Service, Visual Merchandising, Inventory Management, Marketing, Trend Analysis, Forecasting, Social Media, E-commerce, Microsoft Excel, Fashion, Leadership, Apparel, Time Management
Education
Skidmore College 2003 — 2007
Business, Asian Studies
Cary Academy 1999 — 2003
Technology Prep School
Durham Academy
WIRB-Copernicus Group October 2012 - Present
Copernicus Group IRB December 2006 - September 2012
Lineberry Research Associates March 2005 - December 2006
Mutual Distribution Company November 2003 - March 2005
Solvay Pharmaceuticals March 2000 - April 2003
Skills
Talent Management, Compensation, Employee Relations, Benefits Administration, Performance Management, Benefits, Talent Acquisition, HRIS, Employee Benefits, Recruiting, Succession Planning, Deferred Compensation, Human Resources, Process Improvement, Personnel Management, Training, Management, Leadership Development, Policy, Strategy, Business Development, Strategic Planning, Payroll, New Hire Orientations, Employee Training, Customer Service, Workforce Planning, Leadership, Hiring, Program Management, Onboarding, Employee Engagement, Budgets, Organizational..., Sourcing, College Recruiting, Applicant Tracking..., Labor Relations, HR Policies, Interviews, Organizational Design
Education
North Carolina Central University School of Law 2011 — 2015
JD
University of North Carolina at Chapel Hill 1995 — 1999
Bachelor of Arts
INC Research May 2014 - Present
Absolute Clinical, LLC April 2011 - May 2014
Valeant Pharmaceuticals April 2009 - April 2011
King Pharmaceuticals June 2008 - April 2009
GSK March 2001 - June 2008
Schwarz Biosciences 2001 - 2001
Lineberry Research Associates 1996 - 2001
Skills
Clinical Development, Drug Development, CRO, Clinical Trials, GCP, Clinical Research, Regulatory Submissions, Medical Writing, Pharmacology, Neuroscience, CTMS, FDA, Pharmaceutical Industry, Neurology, Regulatory Affairs, Oncology, Drug Discovery, Medical Affairs, Infectious Diseases, Biotechnology
Education
Duke University School of Medicine 1995 — 1996
Post-doc, Neuroscience
Binghamton University 1990 — 1995
PhD, Neuroscience
INC Research January 2015 - Present
INC Research October 2013 - December 2014
INC Research December 2011 - September 2013
INC Research June 2009 - November 2011
INC Research January 2008 - June 2009
i3 Research 2007 - 2007
Lineberry Research Associates 2004 - 2007
University of North Carolina at Chapel Hill 2001 - 2004
Skills
EDC, CRO, GCP, Clinical Trials, Clinical Monitoring, Clinical Development, CTMS, Pharmaceutical Industry, Oncology, ICH-GCP, Clinical Research, Data Management
Education
University of North Carolina at Chapel Hill 1997 — 2001
BS, Biology, Chemistry
Triangle Clinical Research, LLC July 2012 - Present
Piedmont Medical Writers LLC January 2012 - January 2012
Polaris Compliance Consultants, Inc. February 2011 - February 2011
Piedmont Medical Writers LLC June 2010 - December 2010
Lineberry Research Associates/Constella Group August 2004 - March 2007
Lineberry Research Associates October 2001 - April 2004
Lineberry Research Associates January 1999 - September 2001
Skills
Microsoft Office, Clinical Research, Clinical Trials, Clinical Monitoring, Document Quality Control, Pharmaceutical Industry, Regulatory Submissions, Sop, ICH-GCP
Education
North Carolina State University 1994 — 1998
Bachelor of Science (BS), Biology/Biological Sciences, General
Eli Lilly and Company June 2014 - Present
Eli Lilly and Company July 2011 - June 2014
Eli Lilly and Company January 2008 - July 2011
Eli Lilly and Company July 2006 - January 2008
Eli Lilly and Company September 2003 - July 2006
Eli Lilly and Company August 2001 - October 2003
Lineberry Research Associates July 2000 - August 2001
Duke University Medical Center May 1999 - June 2000
Skills
Six Sigma, Critical Chain Project..., Performance Management, Change Management, Coaching, Therapeutic areas, Clinical, Process Improvement, Clinical Trial..., Clinical Development, Clinical Trials, Clinical Research, CRO, Mentoring, Talent Management, Team Leadership, Operations Management, Program Management, Strategic Planning
Education
Indiana University Bloomington 1997 — 1999
Masters of Science, Clinical Exercise Physiology
Indiana University Bloomington 1991 — 1995
Liberal Arts, English
South Spencer High School 1988 — 1991
General Studies
Cempra Pharmaceuticals June 2015 - Present
Salix Pharmaceuticals July 2012 - April 2015
Stiefel, a GSK company July 2010 - July 2012
SRA International September 2000 - February 2009
Constella Group Ltd 2005 - 2007
Lineberry Research Associates 2000 - 2005
Skills
GCP, Adobe Acrobat, Management, SharePoint, Pharmaceutical Industry, Regulatory Affairs, Clinical Trials, Research, CRO, Regulatory Submissions, Sop, Software Documentation, Quality Assurance, FDA, Clinical Research, EDC, CTMS, Microsoft Office, Oncology, Medical Writing, IND, Regulatory Requirements, ICH-GCP, 21 CFR Part 11, NDA, Pharmaceutics, Medical Devices, GxP, Drug Development, eCTD, Therapeutic Areas, Document Management, Documentum, Regulatory Documentation, Regulations, ANDA, Lifesciences, Clinical Development, Validation, Cross-functional Team..., CTD, Pharmacovigilance, Protocol, GMP, Life Sciences, SOP, Infectious Diseases, Leadership, Biotechnology, Microsoft Excel
Education
University of North Carolina at Chapel Hill 1993 — 1997
BA, Anthropology-Ethnology
Durham Academy 1970 — 1980
Duke University Health System January 2014 - Present
Rex Healthcare January 2008 - December 2013
Duke University Health System 2007 - 2008
Select Diagnostics 2006 - 2007
State of North Carolina - Rollins Animal Disease Lab 2005 - 2006
State of North Carolina - Public Health 2004 - 2005
Lineberry Research Associates 2001 - 2003
State of North Carolina - Public Health 1999 - 2001
Kaiser Permanente 1997 - 1999
Burroughs Wellcome 1992 - 1994
Skills
Clinical Microbiology, Bacteriology, Mycology,..., Clinical Data Management, Laboratory, Medicine, Hospitals, Healthcare Information..., Healthcare, Hematology, Laboratory Medicine
Education
Ferris State University 1980 — 1984
Bachelor of Science (B.S.), Medical Technology
United Therapeutics March 2013 - Present
United Therapeutics July 2008 - March 2013
Lineberry Research Associates 2005 - 2007
Boston University School of Medicine 2002 - 2005
Skills
CRO, Biotechnology, CTMS, Clinical Development, Clinical Research, Clinical Trials, FDA, GCP, ICH-GCP
Education
Boston University School of Medicine 2002 — 2005
MA, Pharmacology
Indiana University Bloomington 1997 — 2002
BS, Biochemistry
Indiana University Bloomington 1997 — 2002
BS, Psychology
Quintiles June 2015 - Present
Quintiles May 2014 - Present
Saxon Consulting October 2008 - May 2014
SRA Global Clinical Development January 2007 - September 2008
Lineberry Research Associates 1998 - 2006
Skills
Regulatory Affairs, Medical Writing, Drug Development, Clinical Operations, Medicine, Strategy, Clinical Development, Pharmaceutical Industry, Regulatory Submissions, Clinical Trials, CRO, GCP, Oncology
Education
State University of New York at Buffalo 1986 — 1994
MS, Natural Sciences, PhD, Cancer Pharmacology
Mercyhurst University 1982 — 1986
BS, Biology, Chemistry minor
UCB (Assignment) August 2014 - Present
The BootBra LLC May 2014 - Present
MedImmune (Assignment) February 2014 - June 2014
inVentiv Health October 2008 - December 2012
Quintiles September 2006 - October 2008
Lineberry Research Associates June 2004 - September 2006
Education
Meredith College 2000 — 2004
Bachelor's Degree, Technical Theatre/Theatre Design and Technology
Rho April 2013 - Present
Bioventus [formerly Smith & Nephew- Biologics Division] May 2012 - March 2013
Smith & Nephew February 2009 - April 2012
SRA Global Clinical Development [formerly Constella Group (formerly Lineberry Research Associates) January 2007 - February 2009
Lineberry Research Associates November 1997 - December 2006
Skills
Therapeutic Areas, Clinical Trials, Medical Devices, Clinical Development, FDA, Pharmaceutical Industry, CRO, CTMS, Clinical Research, Clinical Monitoring, GCP, Neuropathic Pain, EDC, Project Management, Drug Development, Class III Medical..., Budgets, Timeline Development, Preparation Of Proposals, Presenting Proposals, CNS disorders, Vendor Management, Clinical Operations, IND, Regulatory Submissions, Sop, Clinical Data Management, ICH-GCP, Regulatory Affairs, Medical Writing, Biotechnology, Phase I, Protocol, Clinical Study Design
Education
Duke University 1992 — 1996
BS, Biology
The Bullis School 1988 — 1992
HS Diploma, Advanced Placement/High Honors Curriculum
Aerial BioPharma, LLC 2011 - Present
Neuronex, Inc April 2010 - December 2012
Addrenex Pharmaceuticals, Inc. June 2006 - December 2009
Alius Pharma, LLC March 2002 - May 2006
Cytran, Inc. August 1999 - February 2002
Lineberry Research Associates 1996 - 1999
Glaxo Wellcome 1987 - 1996
Skills
Clinical Development, Lifesciences, Regulatory Affairs, Pharmaceutical Industry, Licensing, Clinical Trials, Clinical Research, Drug Development, Commercialization, Biotechnology, Competitive Intelligence, Drug Discovery, Biopharmaceuticals, Oncology, Infectious Diseases, CRO, Technology Transfer, Life Sciences
Education
University of North Carolina at Chapel Hill
Ph.D., Psychology
American University of Beirut 1978 — 1981
BA, Psychology
Cognitect November 2012 - Present
2Plus2 Bookkeeping September 2010 - Present
Clinipace Worldwide 2009 - September 2010
Metabolon 2008 - 2009
Constella Group 2007 - 2008
Lineberry Research Associates 2004 - 2007
Lineberry Research Associates December 2001 - February 2005
OAO Corporation 1999 - 2001
Skills
Accounts Payable, Accounts Receivable, Payroll, Accounting, Bookkeeping, Invoicing, Finance, Small Business, Account Reconciliation, Financial Reporting, QuickBooks, Cash Flow
Education
Campbell University 2008 — 2009
BAS, Accounting
Wake Technical Community College 2005 — 2006
Certification, Bookkeeper
North Carolina Army National Guard 2013 - Present
International Research Solutions, Inc 2006 - Present
North Carolina Army National Guard 2011 - 2013
Lineberry Research Associates 2004 - 2007
PPD 2003 - 2004
Skills
Clinical Trials, CRO, GCP, Clinical Development, CTMS, Pharmaceutical Industry, Clinical Research, Regulatory Submissions, Medical Writing, Drug Development, Protocol, Regulatory Affairs
Education
Duke University, Department of Psychiatry and Behavioral Neuropharmacology 2000 — 2003
Postdoctoral Research Associate
Univerisity of St. Andrews, Scotland, U.K. 1995 — 1999
Ph.D., Molecular Cell Physiology
St. John's University 1989 — 1993
Bachelor of Science (BS)
Impact Pharmaceutical Services August 2012 - Present
UCB Biosciences, Inc. April 2010 - August 2012
UCB Biosciences, Inc. April 2009 - April 2010
SRA Global Clinical Development LLC (formerly Constella Group LLC) January 2008 - April 2009
Constella Group LLC (formerly Lineberry Research Associates) May 2006 - December 2007
Lineberry Research Associates April 2005 - April 2006
UNC-Chapel Hill, Dept of Pediatrics October 2004 - April 2005
Lineberger Comprehensive Cancer Center August 2004 - April 2005
UNC-Chapel Hill, Dept. of Pathology November 2003 - August 2004
R. Lawrence Services April 2003 - November 2003
Skills
Medical Writing, Drug Development, Clinical Trials, CRO, Clinical Development, Protocol Writing, Diabetes, Pharmaceutics, GCP, SOP
Education
University of North Carolina at Chapel Hill 1996 — 2000
Doctor of Philosophy (Ph.D.), Chemistry
Roanoke College 1992 — 1996
B.S., Chemistry
Otsuka August 2011 - Present
GlaxoSmithKline August 2008 - August 2011
Pfizer on behalf of ExecuPharm August 2007 - August 2008
GlaxoSmithKline September 2001 - July 2007
GlaxoSmithKline August 2001 - 2007
lineberry research associates January 1998 - August 2003
Lineberry Research Associates August 1998 - August 2001
Blue Cross Blue Shield NC January 1998 - August 1998
Duke Clinical Research Institute August 1997 - 1998
Education
North Carolina Central University 1994 — 1998
BS, Chemistry
UCB Biosciences March 2012 - Present
ICON plc 2011 - 2012
INC Research May 2008 - June 2011
Constella Group (Acquired LRA) 2007 - 2008
Lineberry Research Associates 2005 - 2007
RxEOB 2004 - 2005
Skills
GCP, Clinical Trials, CRO, Clinical Monitoring, Protocol, Clinical Study Design, Clinical Research, Project Management, Clinical Development, Clinical Data Management, Financial Accounting, Clinical Quality, Clinical Trial Analysis
Education
East Carolina University - College of Business 2011 — 2014
MBA
University of Richmond 2002 — 2005
BS
Tulane University 2001 — 2002
Governor's School for Government and International Studies 1997 — 2001
Novartis May 2015 - Present
GSK December 2010 - April 2015
GlaxoSmithKline October 2008 - December 2010
GlaxoSmithKline March 2006 - October 2008
Lineberry Research Associates October 1996 - March 2006
Skills
Clinical Development, Clinical Research, CRO, Pharmaceutical Industry, Clinical Trials, Drug Development, Oncology, Regulatory Submissions, GCP, CTMS, Medical Writing, Clinical Monitoring, ICH-GCP, EDC
Education
University of Richmond 1991 — 1995
Bachelor of Science (BS), Biology
United Therapeutics July 2013 - Present
High Point Clinical Trials Center October 2012 - January 2013
United Therapeutics September 2005 - April 2012
Lineberry Research Associates 1996 - 2005
Lineberry Research Associates (Constella Group) 1996 - 2005
Skills
CRO, Clinical Development, Clinical Trials, GCP, CTMS, Clinical Operations, Clinical Monitoring, EDC, ICH-GCP, Regulatory Submissions, Drug Development, Regulatory Affairs
Education
University of North Carolina at Chapel Hill 1993 — 1996
Pharmacy
University of North Carolina at Chapel Hill 1987 — 1992
BS, Biology
Novartis July 2014 - Present
Novartis July 2012 - June 2014
Novartis February 2011 - July 2012
Roche Pharmaceuticals April 2010 - February 2011
Strativa Pharmaceuticals 2008 - April 2010
Strativa Pharmaceuticals April 2008 - October 2008
Novartis September 2001 - March 2008
Lineberry Research Associates May 2000 - September 2001
Novartis July 1994 - May 1999
Skills
Regulatory Affairs, Clinical Research, Strategy, Pharmaceutical Industry, Clinical Trials, Regulatory Submissions, Clinical Development, Clinical Pharmacology, Drug Development, Oncology, IND, FDA, GCP, Biotechnology, Therapeutic Areas, Infectious Diseases, CRO
Education
University of the Sciences in Philadelphia 1990 — 1992
Pharm.D.
University of Kentucky 1987 — 1990
B.S.
Transylvania University 1985 — 1987
Novella Clinical July 2015 - Present
Novella Clinical, Inc. March 2014 - Present
Novella Clinical, Inc. January 2011 - March 2014
Novella Clinical May 2008 - January 2011
Omnicare May 2007 - May 2008
Constella Group 2007 - 2007
Lineberry Research Associates 2005 - 2007
Constella Group & Lineberry Research Associates 2005 - 2007
Lineberry Research Associates (now SRA) 2005 - 2007
Skills
CRO, Clinical Research, EDC, Clinical Monitoring, CTMS, Clinical Trials, GCP, ICH-GCP, Clinical Development, Pharmaceutical Industry
Education
UNC Chapel Hill 1996 — 2000
BS, Clinical Laboratory Science
University of North Carolina at Chapel Hill 1996 — 2000
BS, Clinical Laboratory Science
Nuventra Pharma Sciences June 2008 - Present
Regado Biosciences 2008 - 2011
Salix Pharmaceuticals 2005 - 2008
Lineberry Research Associates May 2001 - August 2005
Skills
Drug Development, Pharmacokinetics, CRO, Clinical Trials, GLP, Regulatory Submissions, FDA, Protocol, Medical Writing, Clinical Research, Vaccines, Pharmaceutics, Clinical Development, Clinical Pharmacology, Protein Chemistry, Pharmaceutical Industry
Education
Washington State University 1994 — 1999
Ph.D., Biochemistry
Linfield College 1991 — 1994
BS, Chemistry
Social & Scientific Systems May 2014 - Present
Aptiv Solutions (Aptiv Solutions Acquired SRA GCD) September 2011 - Present
SRA International December 2009 - September 2011
SRA International (SRA International Acquired ConstellaGroup) August 2008 - December 2009
Constella Group (Constella Group Acquired Lineberry Research Associates) July 2006 - June 2008
Lineberry Research Associates January 2004 - July 2006
Lineberry Research Associates July 1999 - January 2004
United States Air Force 1992 - 1999
Skills
Management, 21 CFR Part 11, CRO, Computer System..., Clinical Development, Validation, GCP, Security, Software Documentation, Sop, Integration, EDC, CTMS, Clinical Data Management, Clinical Trials, Regulatory Requirements, FDA, Disaster Recovery, SharePoint, SOP
Education
Strayer University-North Carolina 2007 — 2010
Master of Science (M.S.), Management Information Systems, General
Bellevue University 1996 — 1997
BS, Business Administration in Technical Studies
Community College of the Air Force 1992 — 1993
AAS, Electronic Systems Technology
Merck/EP July 2015 - Present
PAREXEL International GSK Business Unit March 2015 - July 2015
GSK November 2014 - March 2015
GSK November 2011 - November 2014
PPD October 2009 - November 2011
PPD March 2008 - October 2009
Lineberry Research Associates 2007 - 2008
Skills
Clinical Development, GCP, CRO, CTMS, Clinical Trials, Clinical Research, Pharmaceutical Industry, EDC, ICH-GCP, Clinical Monitoring
Education
North Carolina State University 1990 — 1994
BS
Impact Pharmaceutical Services 2014 - Present
Impact Pharmaceutical Services 2010 - 2014
Pearl Therapeutics 2009 - 2010
SRA International 2007 - 2009
Constella Group 2006 - 2007
Lineberry Research Associates 2005 - 2006
Lineberry Research Associates 2001 - 2005
Education
Emory University 1996 — 2001
PhD, Pharmacology
Long Island University, Brooklyn Campus 1993 — 1996
BS, Pharmacy
Neuronex, Inc June 2010 - Present
Addrenex July 2008 - January 2010
SRA International, Global Clinical Development (formerly Constella Group) 2007 - 2008
Lineberry Research Associates 1997 - 2008
Education
University of California, Berkeley 1984 — 1990
PhD, Molecular Biology
Penn State University 1980 — 1984
BS, microbiology
Roivant Sciences, Inc. July 2015 - Present
PAREXEL March 2015 - June 2015
GlaxoSmithKline May 2012 - March 2015
GSK May 2005 - April 2012
Lineberry Research Associates May 2000 - May 2005
Glaxo Wellcome June 1992 - June 1999
Skills
Clinical Research, Clinical Development, Clinical Trials, CRO, GCP, Pharmaceutical Industry, Therapeutic Areas, EDC, Medical Writing, Clinical Monitoring, Protocol, Clinical Project..., Clinical Pharmacology
Education
North Carolina State University
B.S., Biological Sciences
Impact Pharmaceutical Services, Inc. August 2009 - Present
SRA International (formerly Constella Group) January 2009 - March 2009
Constella Group (formerly Lineberry Research Associates) January 2008 - December 2008
Lineberry Research Associates May 1997 - December 2007
Skills
Regulatory Affairs, Drug Development, Clinical Operations, Clinical Development, Clinical Trials, Strategy, Pharmaceutical Industry, CRO, Biotechnology, Medical Writing, GCP, Lifesciences
Education
Pennsylvania State University College of Medicine 1991 — 1995
PhD, Pharmacology
Penn State University 1987 — 1991
BS, Biology
Chiltern August 2015 - Present
Clinipace Worldwide (formerly Paragon Biomedical) August 2012 - August 2015
PRA International October 2011 - August 2012
Quintiles August 2008 - September 2011
i3 Research November 2006 - July 2008
PAREXEL June 2006 - October 2006
Lineberry Research Associates August 2001 - June 2006
PharmaLinkFHI 2000 - 2001
Cardinal Health (was Magellan Laboratories) 1997 - 2000
GlaxoSmithKline (was Burroughs Wellcome Pharmaceuticals Co.) 1985 - 1992
Skills
Therapeutic Areas, Clinical Trials, Infectious Diseases, Protocol, Vaccines, Psychiatry, Clinical Research..., Central Nervous System, Quality Assurance, CRO, GCP, Clinical Monitoring, CTMS, Clinical Research, ICH-GCP, EDC
Education
Durham Technical College
Associates 2 year degree, Clinical Trials Research
Elon University
Bachelors Degrees (Double Major), Chemistry & Biology
United Therapeutics Manager, Compliance and Quality AssuranceSRA International, Global Clinical Development
Lineberry Research Associates 1999 - 2006
Education
North Carolina State University 1979 — 1984
B.S., Mathematics, minor Materials Engineering
PPD Medical Communications January 2012 - Present
PPD October 2003 - January 2012
Lineberry Research Associates March 1999 - June 2003
GlaxoWellcome May 1994 - March 1999
Burroughs Wellcome Co. July 1985 - May 1994
Skills
Pharmaceutical Industry, Clinical Research, CRO, GCP, Pharmacovigilance, Medical Writing, Medicine, Medical Affairs, Pharmacists, Oncology, Sop, Biotechnology, Clinical Development, Clinical Trials, Regulatory Affairs, Psychiatry, Clinical Pharmacology, Regulatory Submissions, Drug Development, Clinical Monitoring, Therapeutic Areas, Infectious Diseases
Education
Medical University of South Carolina 1981 — 1983
PharmD
University of North Carolina at Chapel Hill 1975 — 1977
BS Pharmacy
Creighton University 1972 — 1975
Pre-pharmacy coursework
School name:
United Therapeutics, Corp March 2011 - Present
United Therapeutics July 2007 - February 2011
Lineberry Research Associates / Constella Group January 2007 - June 2007
Lineberry Research Associates March 2003 - December 2006
GlaxoSmithKline April 2002 - February 2003
Nortel Networks July 1987 - August 2001
Skills
Protocol, CRO, ICH-GCP, Clinical Trials, GCP, Therapeutic Areas, FDA
Education
Rensselaer Polytechnic Institute 1985 — 1987
Master of Science (MS), Technical Writing, 4.0
State University of New York at Albany 1978 — 1982
Bachelor's degree, Communications, Cum Laude
Durham Technical Community College 2001 — 2003
Certification, Clinical Trials Research Associate Program, 4.0