Regulatory Coordinator, Senior
Lead, coordinate, and perform project-specific and department-wide regulatory processes and ensure compliance with various governing entities for the research portfolio of the Department of Population Health Sciences (DPHS). This encompasses projects focused on health services research and policy, health disparities research, and health outcomes research. This position will advise and mentor junior staff.
- Research Operations: Serve as DPHS resource for development of IRB and other regulatory documents and for communication with regulatory entities, including but not limited to: Institutional Review Boards, Centers for Medicare & Medicaid Services, Agencey for Healthcare Research and Quality, Institutional Security Office, Food and Drug Administration. Train staff to maintain exemplary documentation including data use agreements, data management plans, regulatory binders, etc. Develop and maintain DPHS data asset SOPs, work instructions, procedures, etc. Provide direction to project teams with regard to preparation for project monitoring or audit visits. Address and correct audit/monitor findings. Direct study team's compliance with submission and completion of AE Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) independently. Develop documents related to safety and security (e.g., RDSPs, COIs, DSMPs). Coordinate efforts of external monitoring boards.
- Data and informatics: Make determinations regarding complex data contracts/agreements. Maintain data asset information on DPHS website and in GetData@Duke repository. Coordinate data asset information for inclusion in DPHS DataShare newsletter. Serve as subject matter expert for specific data assets as assigned. Serve as expert user of DPHS data governance information management (REDCap) system. Train other users as needed. Create and maintain training documentation/user’s guide. Identify system problems/opportunities for enhancements and communicate to DPHS Data Steward. Develop and generate reports based on DPHS needs. Process DPHS resource request forms, including review of information submitted; triage to additional reviewers as appropriate; communicate with requestors; document in REDCap system. Verify that all required tasks are complete before granting users access to data assets.
- Leadership: Maintain training requirements and develop solutions to proactively ensure DPHS compliance with training requirements. Provide significant contribution and influence upon research work, activities, or productivity of project teams or across multiple groups. Lead cross-functional committees or task forces charged with improving project processes. Serve as expert mentor to junior regulatory staff. Establish and assign the activities of multiple teams to accomplish project goals. Summarize and clarify for project teams, the professional guidelines and code of ethics related to the conduct of clinical research. Lead or participate in a committee, task force, or ad hoc group at the division, unit, department, or institution level.
- Project and Site Management: Use system reports to ensure departmental compliance with institutional requirements/policies; assist team members with understanding these requirements and policies. Conduct regular reviews of DPHS data management plans. Oversee project teams' maintenance of Delegation of Authority Logs and training of key personnel on project specific requirements.
- Communication: Communicate concerns clearly and in a professional manner. Take action when communication has stalled with team members, collaborators, stakeholders, and/or regulatory or compliance entities. Recognize when team member communication is not going well and troubleshoot or escalate as necessary.