Human Research Protection Program

1 month ago

Arlington, United States Valiant Harbor International, LLC Full time

Valiant Harbor International is seeking an experienced Human Research Protection Program (HRPP) Compliance Specialist to provide support to the Office of Naval Research (ONR) Warfighter Performance Department (Code 34). The HRPP Compliance Specialist will assist in preliminary review of reportable events, including serious adverse events (SAEs), unanticipated problems involving risks to subjects or others (UPIRTSOs) and serious and/or continuing non-compliance; assist in the identification of areas of concern, development of corrective action(s) and recommendations, and drafting of reports.


This position requires a critical thinker who can extract meaning from complex data relationships, identify trends, opportunities, and solutions related to client policy and program areas. Applicants must have a passion for human research protections, be innovative, and possess strong verbal and written communication and analytic skills. The ideal applicant will have demonstrated proficiency and understanding of compliance processes associated with Human Research Protection Programs. A Secret Clearance will be sponsored for the right candidate. The HRPP Specialist will perform a combination of some or all of the following duties:


  • Develop, refine, and manage project management tools for an agency-wide human research protection program.
  • Review and assess agency commands, laboratories, and extramural collaborators for compliance with Federal-level and agency-specific requirements for the protection of human research subjects.
  • Prepare and review Federal wide and DoD Assurance packages for agency components and sponsored entities with human subject research programs.
  • Assist in evaluation of human research protection programs at assigned locations through periodic on-site assist visits, audits, and site inspections, to include post-approval administrative reviews of Department of the Navy (DON) Institutional Review Board (IRB) approved research studies, review of DON Assurance applications, and development of forms, checklists, standard operating procedures, and other human research regulatory compliance tools.
  • Carry out evaluations of unanticipated problems involving risks to subjects or others in agency-sponsored research projects, to include issues involving noncompliance, and developing reports and recommendations for corrective actions.
  • Develop and update processes, materials, and databases for the agency’s human research protections program and its compliance and oversight functions, and assist with the generation of reports, metrics, presentations, and other program deliverables.
  • Providing subject matter expertise and consultation on complex program-level and project-specific initiatives for ensuring the protection of human subjects in all agency-sponsored research activities in accordance with 32 CFR Part 219, DoDI 3216.02 and SECNAVINST 3900.39E CH-1.
  • Some travel may be required.


Required Knowledge, Skills, and Experience:

  • Demonstrated experience preparing or reviewing assurance packages to ensure compliance with federal regulations.
  • Demonstrated experience inspecting and auditing HRPP stakeholders for compliance with federal regulations and guidance.
  • Knowledge of federal regulations, including DoD and DON specific requirements, applicable to the conduct of medical, social, and behavioral research.
  • Demonstrated experience writing HRPP-related policy and guidance for IRBs, investigators, and other HRPP stakeholders.
  • Bachelor’s degree or higher from an accredited college/university.
  • Five (5+) years of work 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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