Maintains essential documents - Properly utilize and maintains the system to store and track required essential regulatory documents according ICH Good Clinical Practice (GCP) guidelines including but not limited to: investigators’ CVs, medical licenses, CITI training, clinical laboratory certifications, etc. • Subject Matter Expertise - Continues to develop knowledge of departmental, IRB (Local and commercial), and institutional processes and helps to ensure that clinical research activities are conducted in compliance with applicable FDA, OPHR, ICH, JC, and other regulatory guidelines.