Michelle Culp joined NCATS as the director of clinical operations of the Division of Clinical Innovation in February 2015. She is responsible for developing and managing innovative and efficient approaches to clinical operations for the Clinical and Translational Science Awards (CTSA) Program and NCATS. She has extensive experience managing clinical trial operations for National Institutes of Health (NIH) and industry studies. In addition, Culp has been on special assignment with the NIH Office of Science Policy, working on clinical trial stewardship reforms, including the NIH Policy on the Use of a Single Institutional Review Board (IRB) of Record for Multi-Site Research, the NIH Policy on Good Clinical Practice Training and other NIH policies on clinical trial stewardship reforms.
Culp earned her M.P.H. from the Johns Hopkins School of Public Health and has more than 20 years of experience in clinical research operations and clinical trial implementation. Prior to coming to NCATS, Culp was the director of the Office of Clinical Trials Operations and Management for the National Institute of Dental and Craniofacial Research, where she oversaw intramural and extramural clinical research. Before that, Culp was chief of the Office of Clinical Research Affairs in the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, where she oversaw the clinical operations for numerous biodefense, influenza vaccine and other global infectious disease trials. She has worked for private pharmaceutical and contract research companies providing clinical trial services, clinical monitoring and project management.
Culp’s areas of expertise include clinical trial operations and management, including protocol writing, site monitoring, quality management, GCP training and implementation of single IRB for multi-site research.