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HRPP Compliance Specialist
2 months ago
Valiant Harbor International, LLC is in search of a qualified Human Research Protection Program (HRPP) Compliance Specialist to support the Office of Naval Research (ONR) Warfighter Performance Department (Code 34). The HRPP Compliance Specialist will play a crucial role in the preliminary assessment of reportable incidents, including serious adverse events (SAEs), unanticipated problems involving risks to subjects or others (UPIRTSOs), and serious and/or ongoing non-compliance issues.
This role demands a critical thinker capable of interpreting complex data relationships, identifying trends, opportunities, and solutions pertinent to client policies and program areas. Candidates should possess a strong commitment to human research protections, demonstrate innovation, and exhibit excellent verbal and written communication and analytical skills. The ideal candidate will have a proven understanding of compliance processes related to Human Research Protection Programs. A Secret Clearance will be sponsored for the right individual.
Key Responsibilities:
- Develop, enhance, and oversee project management tools for a comprehensive human research protection program.
- Evaluate agency commands, laboratories, and external collaborators for adherence to federal and agency-specific regulations regarding the protection of human research subjects.
- Prepare and review federal-wide and DoD Assurance packages for agency components and sponsored entities engaged in human subject research.
- Assist in the evaluation of human research protection programs at designated locations through periodic on-site assistance visits, audits, and inspections, including post-approval administrative reviews of Department of the Navy (DON) Institutional Review Board (IRB) approved research studies.
- Conduct assessments of unanticipated problems involving risks to subjects or others in agency-sponsored research projects, including noncompliance issues, and formulate reports and recommendations for corrective actions.
- Develop and refine processes, materials, and databases for the agency's human research protections program and its compliance and oversight functions, and assist in generating reports, metrics, presentations, and other program deliverables.
- Provide subject matter expertise and consultation on complex program-level and project-specific initiatives to ensure the protection of human subjects in all agency-sponsored research activities in accordance with 32 CFR Part 219, DoDI, and SECNAVINST E CH-1.
- Some travel may be necessary.
Required Knowledge, Skills, and Experience:
- Proven experience in preparing or reviewing assurance packages to ensure compliance with federal regulations.
- Demonstrated experience in inspecting and auditing HRPP stakeholders for compliance with federal regulations and guidance.
- Familiarity with federal regulations, including DoD and DON specific requirements, applicable to medical, social, and behavioral research.
- Experience in drafting HRPP-related policies and guidance for IRBs, investigators, and other HRPP stakeholders.
- Bachelor's degree or higher from an accredited institution.
- Five (5+) years of relevant experience in human research protection.
Clearance Requirements:
- Must be a U.S. Citizen.
- Must possess or be able to obtain an Active Secret Clearance prior to onboarding.
