CBAI and Associates is seeking a Senior Compliance Specialistto provide Human Research Protection Program (HHRP) support to the Office of Naval Research (ONR) in Arlington, VA.
Develop program/project management tools that help define, observe, and assess actions that implement human research regulatory compliance.
Assist in the review and assessment of DON Commands, institutions, and non-DOD collaborators for compliance with applicable Federal, DOD and DON requirements for the protection of human subjects in research.
Compile HRPP-related metrics reports for Code 343 and DON HRPP.
Conduct preliminary review of unanticipated problems involving risks to subjects or others (UPIRTSOs), allegations of serious or continuing non-compliance and research misconduct; assist in identification of areas of concern, corrective action(s) and development of reports and recommendations.
In conjunction with DON personnel, assist in evaluation of human research protection programs at laboratories, training commands, operational commands, systems commands, and DON-supported research involving human subjects performed by non-DOD institutions through periodic on-site assist visits and site inspections.
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, DOD and DON human research protection requirements as part of a continuing quality improvement program.
Write a summary of the findings for each review and after review by government personnel, archive into ONR/DON HRPP IT management system.
Assist in 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.
Assist program office in the development of HRPP policies and procedures, including Work Instructions.
Provide support and human subject protection expertise for human research protections in the Systems Commands, operational forces, training commands, and DON-supported research involving human subjects in accordance with 32 CFR Part 219, DoDI 3216.02 and SECNAVINST 3900.39D.
Assist with preparing and drafting presentations.
Bachelor’s degree and five (5) years of work experience in human research protection.
Experience in working with federal regulations, to include DOD/DON regulations and policies.
Experience reviewing human subject research and assessing it for compliance with federal regulations and guidance.
Experience writing HRPP-related policy and guidance for IRBs, investigators, and other HRPP stakeholders.
Experience preparing assurance packages to ensure compliance with federal regulations.
Experience inspecting and auditing HRPP stakeholders.
Experience with both medical and non-medical research conducted and supported by DOD.
Experience working with senior leadership in the DON HRPP.
Must be able to obtain and maintain a government Secret Clearance.