Independent Consultant Oct 2015 - Jan 2016
Adjunct Faculty
Duke Clinical Research Institute Oct 2007 - Sep 2015
Director Quality Assurance and Reg Compl
University of North Carolina at Chapel Hill 2003 - 2006
Adjunct Clinical Research Associate Professor
Phoenix Data Systems 2001 - 2003
Chief Compliance Officer
Fda 1995 - 2001
Regulatory Health Information Specialist
Education:
University of North Carolina at Chapel Hill 1977 - 1983
Masters, Master of Science In Public Health
Skills:
Regulatory Affairs Clinical Trials Gcp Fda Clinical Development Cro Pharmaceutical Industry 21 Cfr Part 11 Regulatory Submissions Sop Edc Ctms Validation Computer System Validation Biotechnology Drug Development Clinical Data Management Clinical Research Life Sciences Data Management Clinical Trial Management System U.s. Food and Drug Administration Standard Operating Procedure Good Clinical Practice Electronic Data Capture