Metro New York & Southern Connecticut

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, and regulatory document systems. 6. Assists in implementation of improvements and, solutions and assistance as needed under the supervision of senior team members. 7. Manages and monitors technology needs, conducts inventory, and system requirements for the assigned departments. 8. Assists in the development and preparation of budgets. 9. Manages administrative support for activities of one or more departments to ensure timely completion of projects. 10. Ensures compliance with University and federal regulations as they apply to the assigned departments. 11. Assists in reviewing and implements University and departmental policies as they pertain to the administrative functions of the assigned department. 12. May perform other duties as assigned.

Required Skill/ability 1:  

Knowledge of knowledge of Good Clinical Practice guidelines, and federal, state, and local guidelines pertaining to clinical research.