Human Research Protection (HRPP) Compliance Specialist

Valiant Harbor International is a CVE Service-Disabled Veteran Owned Small Business that specializes in technical, programmatic, acquisition, compliance, and financial services for Government science and technology, research and development, and technological programs. At Valiant Harbor International, we emphasize our intense focus on helping federal government agencies identify and address organizational challenges to tailor and integrate specific solutions to solve their most difficult problems. Success is defined by our ability to meet our customer’s needs quickly, efficiently, and effectively —we are a management consulting firm with a successful record of offering a wide range of professional, scientific, and technical services requiring a high degree of expertise and training.

Job Description
Valiant Harbor International is seeking a Human Research Protection (HRPP) Compliance Specialist to provide expertise in human research protection supporting the Warfighter Performance Department (Code 34) at the Office of Naval Research (ONR). ONR provides support and expertise to the Navy Surgeon General (SG) for human research protections in the Systems and Training Commands, operational forces, and Department of the Navy (DoN) supported research involving human subjects performed by non-DoD institutions. The ideal candidate will have experience providing oversight of human subject research and project management support to ensure compliance with federal regulations and department policies.

Job Responsibilities

• Review human subject research to ensure compliance with federal regulations, including DoD/DON policies and guidelines.
• Assist in evaluation of laboratories, training commands, operational commands, systems commands, and navy-supported research involving human subjects performed at service commands, institutions, and non-DoD/DoW collaborators for compliance with applicable federal and service requirements for the protection of human subjects in research.
• Assist in conducting headquarters-level post-approval review of human research protocol submissions, including Institutional Review Board (IRB) meeting minutes to monitor compliance with federal and service human research protection requirements as part of a continuing quality improvement program.
• Assist in identification of areas of concern, corrective action(s) and development of reports and recommendations; conduct preliminary review of unanticipated problems involving risks to subjects or others (UPIRTSOs), allegations of serious or continuing non-compliance, and any suspension or termination of Institutional Review Board (IRB) approval.
• Compile HRPP-related metrics reports for ONR and DoN HRPP; write summaries of findings for each review and after review by government personnel, archive into ONR HRPP specific IT tools/systems, including but not limited to the Research Protections Information Technology Management System (RPITMS).
• Perform administrative and program duties to include but not limited to:

• Development of forms, data, and other human research regulatory compliance items in a centralized, relational database suitable for standard and ad-hoc reporting and analysis.
• Development and revision of HRPP policies and procedures, including DoD/DoW, SECNAV, OPNAV directives, SOPs and Work Instructions.
• Coordinate conference package preparation, track human research protection training, manage human research protection training database and files, teleconference and meeting schedules, and other routine office tasks.

• Must have a current SECRET Clearance or the ability to obtain a SECRET clearance prior to selection.
• Bachelor’s Degree in a relevant field with at least three (3) years of experience in human research protection.

• Demonstrated experience preparing assurance packages to ensure compliance with federal regulations.
• Demonstrated experience inspecting and auditing HRPP stakeholders.
• Demonstrated experience with both medical and non-medical research conducted and supported by DoD/DoW highly desired.
• Demonstrated experience working with senior leadership in defense and service human research protection programs preferred.

Salary Range: $85,000.00 - $95,000.00