AFSC seeks a Human Research Protection Specialist SME with biomedical research expertise to assist with oversight of human research protection programs, Institutional Review Boards (IRBs), human subject protection standards, policy and procedure development, and regulatory compliance.
• Assist in the development and implementation of human subject protection standards, policies, procedures and systems relative to clinical research and cross-discipline human subject research, research subject protection, and institutional and investigator compliance. Serve as point-of-contact for assigned Commands and provide guidance and oversight, as needed.
• Provide consultation for updating regulations and policies at the component level.
• Assess Command compliance with federal and institutional regulations and policies through the following tasks:
• Periodic review of Command Assurances for the protection of human research subjects. Assurance reviews can include an application, Command Instructions, IRB roster, IRB Policies and Procedures, agreements with other Commands, and summaries of training for key staff.
• Review and analysis of institution-specific Management Plans, Instructions, policies, and procedures. Provide a written report for each assessment including specific findings and recommendations to further institutional compliance and/or initiate quality improvements.
• Conduct site inspections and assist visits with Commands on a regular basis. Coordinate with the Command staff and other site inspection or assist visit team members, including leadership, if any. Site inspections and assist visits may include: interviews with human research protection staff, interviews with researchers, review of Command research files, and review of investigator files. Evaluate and assess findings objectively and integrate all activities and results into a final Assessment report or summary.
• Headquarters Level Review of IRB reviewed protocols for which the Program has regulatory oversight. Provide a written report for each protocol reviewed and keep track of trends. Communicate findings to IRB staff to ensure compliance.
• Serve as a subject matter expert to Institutional Officials, Human Research Protections Officers (HRPOs), Institutional Review Board (IRB) members and staff, and other HRPP staff on human research protection and compliance regulations, policies, and procedures. Subject matter expertise includes knowledge of human research ethical foundations, federal regulations, requirements, GCP standards, and standards for the responsible conduct of research.
• Serve as site inspection or assist visit team member for other HRPP staff members, as needed.
• Perform full range of subject matter research and analyses. Interpret results to determine validity and significance. Prepare written reports presenting the results, interpretations, conclusions, and impact analysis. Identify need for new processes, systems, methods or approaches, guidance documents, standards, and training needs.