Human Research Protections Program (HRPP) Compliance Specialist

Valiant Harbor International is a CVE Service Disabled Veteran Owned Small Business that specializes in program, acquisition, and financial services for Government science and technology, research and development, and technological programs. Here at Valiant Harbor International we emphasize extreme focus on helping federal government agencies identify and address organizational challenges in order to tailor and integrate specific solutions to solve their most difficult problems. Success is defined by our ability to meet our customer's needs- we are a management consulting firm with a successful record of offering a wide range of professional, scientific, and technical services requiring a high degree of expertise and training.

Job Description

Valiant Harbor International (VHI) is seeking HRPP Compliance Specialist to join our team in Arlington, VA. The successful candidate will play a critical role extracting 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.

Job Responsibilities

• 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.
  
  

Job Requirements

• 5 years of experience in Human Research Protection.
• Bachelor's degree in Human Resource or equivalent.
• Have or Eligible to obtain Secret Clearance
• 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.
  
  

Salary Range: $85,000.00 - $95,000.00