Senior Human Research Protection Program (HRPP) Compliance Speci with Security Clearance

Senior Human Research Protection Program (HRPP) Compliance Specialist Location: Arlington, VA FT/PT Status: Full Time Required Clearance: Secret Overview: Strategic Analysis, Inc. (SA) 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. As a Senior HRPP Compliance Specialist, you will:
• 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. Qualifications:
• U.S. Citizen with a SECRET clearance or the ability to obtain one.
• Ability to work onsite in Arlington at least three (3) days a week
• 5+ years of experience in Human Research Protection.
• Bachelor's degree in Human Resource or equivalent.
• 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. Strategic Analysis, Inc. is an Equal Opportunity employer and is committed to non-discrimination in employment. All qualified applicants will receive consideration for employment without regard to race, color, religions, sex (including pregnancy, sexual orientation, or gender identity), national origin, disability (physical or mental), age (40 or older), protected veteran status, genetic information (including family medical history) or any other characteristic protected by law. This policy includes but is not limited to the following employment actions: recruitment, hiring, firing, promotion, demotion, compensation, fringe benefits, training, mentoring and sponsorship programs.