1. Manages processing, tracking, and filing of study documents and updates including adverse and serious adverse events, IND Safety Reports, Investigator Brochures, Package Inserts, and Instructions for Use.  2. Collaborates with Investigators, study teams, and Project Managers to gather, review, and maintain essential regulatory documents.  3. Collates aggregate study data into reports for external audiences including data and safety monitoring groups, regulatory authorities, and project funders. 4. Assists Project Managers in study oversight responsibilities and supports study management activities including drafting and revising study specific materials. 5. Manages study systems set up, access, and revisions, including Clinicaltrials.gov, CTMS (OnCore), Electronic Data Capture Systems,