- Serve as a senior subject matter expert supporting OHRP's compliance oversight mission and the protection of human subjects research.
- Evaluate compliance with 45 CFR 46 (the Common Rule) and advise OHRP leadership on regulatory, ethical, and operational issues.
- Conduct comprehensive reviews of complaints, incident reports, allegations of noncompliance, and IRB regulatory determinations.
- Prepare detailed analyses, case summaries, and briefing materials to support leadership decision-making.
- Develop and maintain compliance review schedules and proactively address risks to ensure timely reporting.
- Perform in-depth analysis of complex compliance cases and evaluate institutional responses and corrective action plans.
- Support the implementation of policies and procedures to ensure compliance with evolving laws and regulations.
Project ManagementMicrosoft Office