Prologue Research
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Prologue Research Employees
ProNAi Therapeutics, Inc. June 2014 - Present
Nadolny Consulting Services November 2012 - June 2014
Veeda Clinical Research April 2008 - September 2012
Prologue Research July 2007 - April 2008
Prologue Research January 2007 - July 2007
BioNumerik Pharmaceuticals July 2001 - December 2006
Duke University Medical Center / Cancer Center Protocol Office June 1997 - July 2001
Duke University Medical Center / Cancer Center Protocol Office September 1995 - June 1997
Duke University Medical Center / Cancer Center Protocol Office February 1995 - August 1995
Duke University Medical Center / Bone Marrow Transplant Clinic February 1992 - September 1994
Skills
Clinical Research, Oncology, GCP, ICH-GCP, Pharmaceutical Industry, Clinical Development, Project Management, Clinical Monitoring, Regulatory Affairs, Clinical Data Management, EDC, SOP development, CTMS, Phase I, Phase 2, Phase 3, Therapeutic Areas, Pharmacovigilance, Clinical Operations
Education
Springfield College 1987 — 1989
BS, Health Service Administration; Business Management
State University of New York at Morrisville 1985 — 1987
AA, Business Administration
Takeda Pharmaceuticals July 2014 - Present
Kilbury Clinical Consulting, LLC August 2011 - Present
Novella Clinical Resourcing August 2011 - July 2014
OSI Pharmaceuticals May 2009 - June 2011
Prologue Research October 2007 - May 2009
i3 Research August 2004 - September 2006
Allos Therapeutics January 2002 - August 2004
Pfizer Pharmaceuticals October 2000 - January 2002
Skills
CRO, Oncology, Clinical Research, Clinical Development, Clinical Operations, Clinical Trials, CTMS, Biomarkers, Clinical Data Management, Biotechnology, Clinical Monitoring, Cross-functional Team..., Drug Development, EDC, GCP, Pharmaceutical Industry, Pharmacovigilance, Regulatory Affairs, Therapeutic Areas
Education
The Ohio State University 1991 — 1996
Liberal Arts
Novella Clinical, Inc. July 2014 - Present
Spectrum Pharmaceuticals October 2012 - July 2013
Ockham July 2013 - July 2014
Novella Clinical, Inc. February 2009 - October 2012
Prologue Research August 2007 - January 2009
Prologue Research International, Inc June 2006 - August 2007
Prologue Research International, Inc May 2002 - May 2006
Mount Carmel Health System February 2001 - May 2002
Mount Carmel East Hospital November 1999 - February 2001
Remington-Davis Clinical Research October 1996 - October 1999
Skills
Clinical Research, Clinical Trials, Oncology, Clinical Trial..., Clinical Monitoring, CTMS, GCP, Pharmacovigilance, CRO, Therapeutic Areas, Infectious Diseases, Protocol, Neurology, CRF design, Sop, FDA
Education
Mount Carmel College 1986 — 1989
RN Diploma, Nursing
PRA Health Sciences August 2011 - Present
PAREXEL March 2007 - August 2011
Prologue Research April 2005 - March 2007
PRA International November 2002 - April 2005
PRA International January 2002 - October 2002
Hematology and Oncology Associates of Va. (Virginia Cancer Institute) July 1997 - December 2001
Medical College of Virginia/Massey Cancer Center November 1990 - July 1997
Skills
Oncology, Clinical Research, Clinical Trials, Clinical Monitoring, EDC, GCP, CRO, Data Management, ICH-GCP, Regulatory Affairs, CTMS, Clinical Development, Sop, FDA, Protocol, Clinical Data Management, Medical Writing, Regulatory Requirements, Clinical Operations, Neurology, Pharmaceutical Industry, Biotechnology, Therapeutic Areas, Oncology Clinical..., SOP, Regulatory Submissions
Education
Central Michigan University 1988 — 1990
MS, Health Administration
Virginia Commonwealth University 1979 — 1984
BA, History/Education
Thomas Jefferson High School
Novella Clinical, Inc. November 2011 - Present
Novella Clinical, Inc. June 2010 - November 2011
Prologue Research February 2010 - November 2011
Prologue Research February 2008 - February 2010
Prologue Research May 2007 - February 2008
The Entrepreneurship Institute June 1995 - April 2007
Columbia University September 2000 - December 2006
Skills
Oncology, Clinical Development, New Business Development, Lead Generation, Event Planning, Strategic Partnerships, Financial Analysis, Pipeline Analysis, Clinical Trial..., Clinical Trial Analysis, Clinical Trial..., Global Clinical Trial..., Proposal Writing, Laboratory, Clinical Trials, Feasibility Studies, Pipelining, CRO, CTMS, Clinical Research, Pharmaceutical Industry, Cancer, Cross-functional Team..., Biotechnology, Lifesciences, EDC, GCP, Infectious Diseases, Drug Development, Business Development, Clinical Data Management, ICH-GCP, Clinical Monitoring, Regulatory Affairs, Molecular Biology, Biopharmaceuticals, Strategy, Market Research, Therapeutic Areas, Life Sciences
Education
Columbia University 2000 — 2006
PhD, Cell and Molecular Oncology: p53 tumor suppressor regulation
Massachusetts Institute of Technology 1996 — 2000
BS, Biology; minor in Biomedical Engineering; concentration in music
Hapa Consulting Inc April 2011 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" March 2009 - May 2011
Prologue Research January 2005 - January 2009
PRA International 2003 - 2004
Skills
EDC, Oncology, Inform, Clinical Monitoring, CTMS, Clinical Data Management
Education
Southwest Baptist University 1993 — 1998
Bachelor of Science (BS), Biology, General
Southwest Baptist University
Master of Science (MS), Health/Health Care Administration/Management
Pharmasset, Inc. September 2007 - Present
Sigma-K Corporation August 1998 - September 2007
Prologue Research 2001 - 2004
Education
Selinsgrove High School 1977 — 1980
University of South Carolina-Columbia
B.S., Molecular Biology
Novocure Inc. August 2013 - Present
The Navicor Group June 2005 - August 2013
INC Research September 2004 - June 2005
Prologue Research May 2000 - September 2004
The Ohio State University January 1999 - May 2000
University of Arkansas/Arkansas Cancer Research Center July 1998 - January 1999
University of Arkansas -Pediatrics June 1995 - July 1998
Skills
Medical Writing, Clinical Trials, Oncology, Medical Genetics, Training, Hematologic Malignancies, Project Management, Immunology, Pharmaceutical Industry, Oncology Advertising, Medical Education, Clinical Research, CRO, Cross-functional Team..., Presentations Skills, Cancer, Biotechnology, Written & Oral..., Neurology, Pharmaceutics, Hematology, Clinical Development
Education
Virginia Commonwealth University School of Medicine 1993 — 1995
MS, Genetic Counseling
The Ohio State University 1988 — 1992
BS, Molecular Genetics
PAREXEL International, LLC September 2007 - Present
Prologue Research January 2005 - June 2007
PAREXEL International, LLC March 2003 - December 2005
Kforce June 2002 - February 2003
PAREXEL International, LLC January 2001 - May 2002
PAREXEL International, LLC October 1992 - December 2000
PAREXEL International, LLC July 1991 - September 1992
various 1980 - 1991
Skills
CRO, Regulatory Affairs, Clinical Development, Clinical Trials, Pharmaceutical Industry, Business Development, Clinical Research
Education
University of California, San Diego 1978 — 1980
Biology
Glendale Community College 1976 — 1978
Associate of Arts (AA), Biology/Biological Sciences, General
Professional Research Consulting, Inc. February 2006 - Present
N/A - freelance December 1999 - Present
Richardson Consulting Services April 2009 - October 2009
Gilead Sciences 2007 - 2008
Ethicon Endo-Surgery 2007 - 2007
Kos Pharmaceuticals December 1999 - December 2006
Myogen (now Gilead) 2003 - 2005
Progenics Pharmaceuticals 2002 - 2003
Prologue Research 2001 - 2003
Millenix 2000 - 2000
Skills
Clinical Trials, Clinical Development, Oncology, CTMS, CRO, EDC, Infectious Diseases, GCP, Clinical Monitoring, Clinical Research, Therapeutic Areas, Vaccines
Education
University of Rochester 1985 — 1989
BA, Biology and Psychology
Navidea June 2012 - Present
Veeda Clinical Research September 2008 - May 2012
Veeda Oncology 2008 - May 2012
Prologue Research 2002 - 2007
Neoprobe Corporation 1996 - 1999
Pharmacia and Upjohn 1987 - 1996
Skills
Data Management, CRO, CTMS, EDC, GCP, Clinical Development, Oncology, ICH-GCP, Clinical Trials, Sop, Pharmaceutical Industry, Leadership, Clinical Research, GLP, Biotechnology, Clinical Data Management, Regulatory Affairs, SOP
Education
The Ohio State University 1980 — 1984
Bachelor of Science (BS), Biochemistry
Clinical Research July 2011 - Present
ICON Clinical Research July 2009 - July 2011
Prologue Research November 2007 - June 2009
i3 Statprobe 2002 - 2006
MetroMed / Lexis Pharmaceuticals 1985 - 1987
Skills
Regulatory Affairs, Clinical Operations, CRO, Clinical Development, CTMS, Clinical Research, GCP, EDC, Clinical Trials, Lifesciences, Project Management, Product Development, Clinical Data Management, Oncology, Operations Management, Pharmacokinetics, Drug Development, State Formularies, Regulatory Submissions, Life Sciences
Education
Duke University 1979 — 1981
Radiology
Loyola University Chicago 1975 — 1979
B.S., Biology
Vector Oncology June 2014 - Present
PRA International July 2013 - May 2014
PRA International January 2012 - June 2013
Novella Clinical, Inc. June 2011 - January 2012
Prologue Research October 2005 - June 2011
The Ohio State University July 1998 - October 2005
Skills
Clinical Trials, Oncology, Clinical Research, Hematology, Pre-clinical Studies, Pulmonary Diseases, ICU, Bioequivalence, Stem Cell Transplant, Cancer Immunotherapy
Education
The Ohio State University 1990 — 1995
Bachelor of Science (BS), Zoology/Animal Biology
The Ohio State University Medical Center 2010 - Present
Prologue Research August 2006 - January 2009
Novella Clinical (formerly Prologue Research) 2006 - 2009
Education
Hampton University 1994 — 2000
B.S, Biology
Allegheny-Singer Research Institute August 2011 - Present
Hematolgy/Oncology Consultants, Inc. June 2009 - June 2010
Prologue Research October 2005 - January 2009
Skills
CTMS, Clinical Monitoring, Clinical Trials, EDC, CRO, Clinical Research, Clinical Data Management, Oncology, Clinical Development, Phase I, GCP, ICH-GCP, Oracle Clinical, Pharmaceutical Industry, Biotechnology, CRF design, Therapeutic Areas, Inform, Regulatory Affairs, Pharmacovigilance
Education
Maryville College 1967 — 1971
BA, Biology
ClinSource Partners, LLC October 2013 - Present
ClinSource Consulting, LLC June 2006 - Present
Cerexa September 2012 - September 2013
Genentech April 2010 - September 2012
Roche Molecular Diagnostics September 2010 - April 2011
Genentech August 2008 - 2010
Eli Lilly August 2007 - August 2008
Pfizer Pharmaceuticals June 2006 - August 2007
GenVec December 2005 - June 2006
Prologue Research March 2005 - December 2005
Skills
Clinical Trials, Clinical Research, GCP, Clinical Development, Oncology, Pharmaceutical Industry, CTMS, Biotechnology, CRO, Protocol, Clinical Monitoring, EDC, Infectious Diseases
Education
Kennedy Western University
BS, Healthcare Administration
Vector Oncology October 2013 - Present
Novella Clinical, Inc. 2010 - October 2013
Prologue Research November 2009 - 2010
Prologue Research 2008 - November 2009
Prologue Research 2006 - 2008
Skills
GCP, CRO, EDC, CTMS, Data Management, Clinical Data Management, ICH-GCP, Clinical Trials, Clinical Development, Oncology
Education
Muskingum College 1985 — 1989
Bachelor of Science, Biology
Muskingum University 1985 — 1989
Bachelor of Science (B.S.), Biology/Biological Sciences, General
Navida Biopharmaceuticals February 2013 - May 2014
Novella Clinical, Inc. February 2011 - February 2013
Prologue Research August 1999 - January 2009
Skills
Microsoft Excel, Human Resources, Outlook, Data Entry, Recruiting, Microsoft Office, Customer Service, Training, Microsoft Word, PowerPoint, Administrative..., Clinical Trials, Research, Access, GCP, Pharmaceutical Industry, Clinical Research, SOP
Education
Columbus State
Certification in Deaf Studies, American Sign Language Interpretation
Marion Technical College
Nursing
Roxane Laboratories, Inc. (a division of Boehringer Ingelheim) June 2004 - Present
Prologue Research January 2001 - June 2004
Progenics Pharmaceuticals March 1994 - December 2000
Memorial Sloan-Kettering Cancer Center January 1990 - March 1994
Skills
Clinical Research, Clinical Trials, Project Management, Bioequivalence, Pharmacokinetics, Generic Drugs, FDA, Clinical Development, Pharmaceutical Industry
Education
New York University
Master of Science, Physiology
Ohio University
Bachelor of Science, Zoology
Novella Clinical, Inc. September 2013 - Present
Kroger August 2008 - Present
Novella Clinical, Inc. June 2013 - September 2013
Prologue Research 2007 - 2007
Education
The Ohio State University 2008 — 2013
Bachelor of Science (BS), Biological and Physical Sciences