Job Details

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Title Human Research Protection Specialist Subject Matter Expert
City Falls Church
State VA
Description 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.
Requirements Skills Needed:
• Subject matter expertise in human research protection, including application of the Common Rule and subparts B, C and D; HIPAA; and other human research protection regulatory requirements
• Exceptional communication skills (verbal and written), with proven technical writing abilities (Writing sample required to be provided)
• Superior analytic, problem solving, and negotiating skills
• Excellent demonstrated project and time-management skills
• Demonstrated success in change management
• Travel required up to 8 times per year. Travel to domestic and international destinations possible
• Human subjects protection and regulatory compliance certification (or obtained within 6 months of hire)
• Must be able to work independently in Microsoft Windows 7 and Microsoft Office 2010 (Excel, Outlook, Powerpoint, Publisher, and Word)
• Interim Secret Clearance required to start

Preferred skills:
• 4+ years post advanced-degree experience in relevant field(s)
• Biomedical experience preferred
• Experience conducting human subject research
• Experience with military health topics, such as post-traumatic stress disorder or traumatic brain injury
• Experience working with Institutional Review Boards

Education and Experience:
• Minimum of 4 years’ experience in human research protection and compliance oversight
• Bachelor's degree in biomedical or socio-behavioral field required, Master's degree preferred

Physical Requirements:
The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

General Office Demands:
• Must accurately record your daily timesheet per AFSC’s Timekeeping Policy
• Must be able to operate general office equipment including but not limited to: computer, phones and related media and information devices on most or all workdays
• Ability to communicate and interact with others, both in person and/or by telephone to conduct business
• Working under time pressure
• Working rapidly for long periods to meet deadlines
• Must be able to travel as needed and adhere to AFSC travel policies and procedures.
• Physical requirements can typically be characterized as active: Lifting, bending, sitting on the floor, climbing may be required in the position. Requires lifting or moving various pieces of equipment, maximum 40 lbs. Position may require work on hands and knees to conduct program activities.

Major Job activities and mental requirements:

• Multiple concurrent tasks
• Ability to perform under stress
• Reading and comprehension
• Writing
• Problem solving
• Confidentiality
• Customer contact

Our Equal Employment Opportunity Policy:
Armed Forces Services Corporation (AFSC) is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
  • Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
  • Please view Equal Employment Opportunity Posters provided by OFCCP here.
  • The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
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