Human Research Protection Analyst Summary
The Human Research Protection Analyst supports the Human Research Protection Program (HRPP) by ensuring compliance with federal regulations, ethical standards, and institutional policies governing human subjects research. This position provides regulatory guidance, conducts compliance reviews and site inspections, supports Institutional Review Boards (IRBs), and serves as a subject matter expert on human research protections.
Job Duties
- Conducts compliance review of IRB minutes and protocol submissions to monitor compliance with Federal, Department of War (DoW), and Navy human subjects research requirements.
- Serves as point-of-contact for assigned commands and provides guidance, training, and oversight, as needed.
- Serves as a subject matter expert to HRPP staff, IRB members, Human Research Protections Officials (HRPOs), and others, as needed, on human subjects research regulations, policies, and procedures. Subject matter expertise must include knowledge of applicable Federal, DoW, Navy, and Food and Drug Administration (FDA) regulations, requirements, and standards.
- Conducts site assessments and assist visits with Navy commands research sites on a regular basis.
- Coordinates with the command HRPP staff and other site assessment or assist visit team members, including leadership. Site assessments and assist visits may include interviews with human research protection staff, interviews with researchers, review of command HRPP files, and review of investigator files.
- Evaluates and assess visit findings objectively and integrates all activities and results into a final assessment report or summary.
- Serves as a site assessment or assist visit team member for other DON HRPP visits, as needed.
- Assists in the development and implementation of human subject protection standards, policies, procedures and systems relative to medical research and cross-discipline human subjects research, research subject protection, and institutional and investigator compliance.
- Periodically reviews command assurances for the protection of human subjects. Assurance reviews can include an application, command instructions, IRB roster, HRPP Policies and Procedures, agreements, and other documents.
- Reviews and analyzes institution-specific HRPP instructions, policies, and procedures. Provides feedback including specific findings and recommendations to further institutional compliance and/or initiate quality improvements, as needed.
- Interprets results of compliance reviews and analysis to determine significant trends, and prepares and presents reports, interpretations, conclusions, and impacts of these trends.
- Identifies need for new processes, systems, methods or approaches, guidance documents, standards, and training needs for the supported HRPPs.
- Provides consultation for updating regulations and policies, as needed.
- Produces high-quality graphs using Excel, specialized analytics software, and leveraging artificial intelligence (AI) resources, as appropriate.
Job Requirements
Bachelor's degree in biomedical or socio-behavioral field required. Masters preferred.
Minimum of 4 years' experience in human research protections and compliance oversight, including experience supporting an IRB.
Exceptional communication skills (verbal and written), with proven technical writing abilities (Writing sample required to be provided).
Proficiency in data analytics and visualization tools (such as Excel, Power BI, Tableau) including AI utilities, to generate executive-ready data displays and reports.
Travel: Domestic and International required up to 4 times per year. Passport Required.
Human research protections or regulatory compliance certification (or obtained within 6 months of hire) is preferred.