Sr. HRPP Specialist

About the role

BCS Allegient has a 35-year history of helping government, research, and private sector clients implement their programs and missions to achieve success. We offer a breadth of professional support services in the areas of business management, communications, systems engineering, analysis, mission execution, and organization performance. The position is hybrid, requiring up to 3 days a week onsite in Arlington, VA.

Responsibilities

• 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-DOW collaborators for compliance with applicable Federal, DOW and DON requirements for the protection of human subjects in research.
• 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-DOW 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, DOW 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.
• Complete government provided training to utilize DON HRPP specific IT tools/systems during performance, including but not limited to the Research Protections Information Technology Management System (RPITMS).
• 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 3900.39E CH-1.
• Assist with preparing and drafting presentations.

Requirements

• Current SECRET Clearance or the ability to obtain a SECRET clearance
• A Bachelor’s Degree from an accredited college or university and five (5) years of work experience in human research protection
• Demonstrated experience in working with federal regulations, to include DOW/DON regulations and policies
• Demonstrated experience reviewing human subject research and assessing it for compliance with federal regulations and guidance
• Demonstrated experience writing HRPP-related policy and guidance for IRBs, investigators, and other HRPP stakeholders
• Demonstrated experience preparing assurance packages to ensure compliance with federal regulations
• Demonstrated experience inspecting and auditing HRPP stakeholders
• Desired: Demonstrated experience with both medical and non