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Human Research Protection Specialist- Subject Matter Expert
Armed Forces Services Corporation/ Magellan Federal
August 30, 2018
Falls Church, Virginia
Full Time - Experienced
Academic / Research
4 Year Degree
AFSC seeks a Human Research Protection Specialist SME with biomedical research expertise to assist with oversight of human research protection programs (HRPPs), Institutional Review Boards (IRBs), human subject protection standards, policy and procedure development, and regulatory compliance.
Manage support services for the Department of the Navy Human Research Protection Program (DON HRPP) in accordance with the performance work statement.
Serve as Team Lead and direct supervisor for team of contract support staff, including: 2 Administrative staff members, 1 Training and Education Specialist and 4 Compliance Analysts.
Track status of all projects and assignments in accordance with the performance work statement and provide routine updates on the status of the performance work statement to the Contracting Officer Representative (COR).
Review drafts submitted by the support staff, including: site inspection and assist visit agendas, site inspection reports, assist visit summaries, official emails drafted on behalf of DON HRPP to Institutions, etc.
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 recommendations for updating regulations and policies at the component level.
Provide guidance to HRPP personnel in the application of human subjects protection regulations, including 32 CFR 219, DoDI 3216.02, and SECNAVINST 3900.39E.
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 HRPP Instructions, policies, and procedures. Provide a written report for each assessment including specific findings and recommendations to further Institutional regulatory compliance
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 approved 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), 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, good clinical practice 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.
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, planning, problem solving, and negotiating skills
Excellent demonstrated project, organizational, 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
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
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
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.
Internal Number: 18-0689
About Armed Forces Services Corporation/ Magellan Federal
AFSC provides staffing and support to many of the most vital government programs strengthening lives within the military community and beyond. We are recognized for our deep commitment to helping government improve, and for bringing the extra effort and innovation required. Our programs range from small teams of strategic experts to very large teams of case managers. To explore ways to be a part of our team where 96% of our employees surveyed feel that AFSC is a great place to work, click on any of our current job openings listed below. We are seeking professional, dedicated individuals that want to make a difference in their work!