Human Research Protection Specialist, DONHRPP, Falls Church, Virginia

The Human Research Protection Specialist will assist with oversight of human research protection programs, Institutional Review Boards (IRBs), human subject protection standards, policy and procedure development, and regulatory compliance.

• Assists 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.
• Serves as point-of-contact for assigned Commands and provide guidance and oversight, as needed.
• Provides consultation for updating regulations and policies at the component level.
• Assesses Command compliance with federal and institutional regulations and policies through the following tasks:
• Periodically reviews 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.
• Reviews and analyzes 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.
• Conducts 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.
• Serves as site inspection or assist visit team member for other HRPP staff members, as needed.
• Performs full range of subject matter research and analyses. 
• Interprets results to determine validity and significance. Prepare written reports presenting the results, interpretations, conclusions, and impact analysis.
• Identifies need for new processes, systems, methods or approaches, guidance documents, standards, and training needs.

The job duties listed above are representative and not intended to be all-inclusive of what may be expected of an employee assigned to this job. A leader may assign additional or other duties which would align with the intent of this job, without revision to the job description.

Other Job Requirements

Responsibilities

Minimum of 4 years’ experience in human research protection and compliance oversight
Bachelor's degree in biomedical or socio-behavioral field required.
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 to domestic and international destinations possible Travel required up to 8 times per year.
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.

General Job Information

Title

Human Research Protection Specialist, DONHRPP, Falls Church, Virginia

Grade

24

Work Experience - Required

Research

Work Experience - Preferred

Education - Req