3+ years of experience in human research protection.
Current SECRET Clearance or ability to obtain one.
Experience preparing assurance packages for compliance with federal regulations.
Experience inspecting and auditing HRPP stakeholders.
Familiarity with medical and non-medical research supported by DoD/DoW.
Experience collaborating with senior leadership in defense research programs.
Responsibilities
Review human subject research for compliance with federal regulations and DoD/DON policies.
Evaluate laboratories and commands for adherence to human subject protection requirements.
Conduct post-approval reviews of human research protocols and IRB meeting minutes.
Identify compliance concerns and develop corrective action reports.
Compile HRPP-related metrics reports and archive findings in IT systems.
Develop forms and data for regulatory compliance in a centralized database.
Coordinate training and manage HRPP training databases and schedules.
Benefits
Full-time position with a structured work environment.
Opportunity to work with senior leadership in defense research.
Engagement in critical compliance oversight for human research.
Access to specialized training and development in HRPP.
Involvement in a mission-driven organization supporting Navy operations.
Full Job Description
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.
Job Requirements
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
This is a full time position
About Consolidated Precision Products Corp.
Consolidated Precision Products Corp. is a manufacturer of complex metal components and products for the aerospace and defense industries. The company was founded in 1991 and is headquartered in Carrollton, Texas. Consolidated Precision Products Corp. operates a network of manufacturing facilities across the United States, as well as in Mexico and Europe. The company's products include castings, forgings, and machined components, as well as assemblies and sub-assemblies. Consolidated Precision Products Corp. is committed to providing high-quality products and services to its customers.
