Human Research Compliance Specialist

2 weeks ago


Arlington, Virginia, United States Valiant Harbor International, LLC Full time

Valiant Harbor International, LLC is looking for 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 evaluation of reportable incidents, including serious adverse events (SAEs), unanticipated problems involving risks to subjects or others (UPIRTSOs), and serious and/or ongoing non-compliance.

This role demands a critical thinker capable of deriving insights from intricate data relationships, identifying trends, opportunities, and solutions pertinent to client policies and program areas. Candidates should possess a strong commitment to human research protections, exhibit innovation, and demonstrate excellent verbal and written communication and analytical skills. The ideal candidate will have a solid 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 an agency-wide 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 assessing 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 evaluations of unanticipated problems involving risks to subjects or others in agency-sponsored research projects, including issues of non-compliance, and develop reports and recommendations for corrective actions.
  • Update 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 Qualifications:

  • 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.
  • Knowledge of federal regulations, including DoD and DON specific requirements, applicable to medical, social, and behavioral research.
  • Experience in drafting HRPP-related policy and guidance for IRBs, investigators, and other HRPP stakeholders.
  • Bachelor's degree or higher from an accredited institution.
  • Five (5+) years of 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.


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