Sharon A. Mavroukakis
Sharon Mavroukakis holds a BSN from the University of Delaware and an MS from the University of Maryland. With over 30 years of experience in the research environment of the National Institutes of Health, Ms Mavroukakis has extensive experience providing clinical and regulatory support to clinical trials adhering to federal, state and local regulations and guidances for human subjects research, including support for protocol and consent writing and management throughout the protocol life-cycle, IND development and management, monitoring and quality control. She has successfully submitted more than 50 IND and IDE applications to FDA (both CDER and CBER), and successfully submitted more than 15 applications to Office of Biotechnology Activities (OBA/RAC) and Institutional Biosafety Committees (IBC) for gene therapy clinical trials. Ms Mavroukakis has extensive experience in utilization and disposition of source documents, application of federal regulations (GCP, FDA, OHRP, OBA) and IRB guidelines, and implementation of data management requirements for clinical trials, including developing Case Report Forms and instructions, and monitoring IND single institution and multi-center clinical trials.