Clinical Researcher and Certified biomedical research compliance professional with over 20 years experience in a broad range of clinical research activities and a passionate dedication to the ethical conduct of human research
Specialties:
• Monitoring the conduct of clinical research trials to assure the rights and welfare of research participants and to optimize compliance with federal, state and UCSF policies
• In-depth knowledge of Good Clinical Practices (GCP), ICH guidelines; FDA and VA regulations for monitoring compliance of clinical trials
• On-site assessment and training of clinical research personnel in research compliance
• Identifying areas for improvement, and to suggesting remedies based on existing policies/procedures and current or projected staffing levels
• Analyzing submissions to the Institutional Review Board to facilitate timely approval