Human Research Compliance Analyst - Remote

Overview

We are seeking a Human Research Compliance Analyst to support a long-term contract with the Office of Naval Research in Arlington, VA. This role is vital for analyzing complex data, identifying trends, and ensuring compliance with policies and programs related to human research protections.

In Short

• Develop, enhance, and manage project management tools supporting the agency-wide Human Research Protection Program (HRPP).
• Review and assess compliance of agency units, laboratories, and external collaborators with federal and agency-specific human research regulations.
• Prepare and review Federalwide Assurance (FWA) and Department of Defense (DoD) Assurance packages for internal and sponsored research programs.
• Conduct on-site visits, audits, and inspections to evaluate HRPP compliance, including administrative reviews of Department of the Navy (DON) Institutional Review Board (IRB)-approved studies.
• Investigate unanticipated problems or incidents of noncompliance that pose risks to research subjects; prepare reports and recommend corrective actions.
• Support the development and maintenance of program databases, processes, metrics, forms, standard operating procedures (SOPs), checklists, and other compliance tools.
• Serve as a subject matter expert on relevant regulations, including 32 CFR Part 219, DoDI 3216.02, and SECNAVINST 3900.39E CH-1.
• Assist in preparing reports, presentations, and other deliverables to support the agency’s HRPP oversight and compliance functions.

Requirements

• At least 3 years of experience in Human Research Protection or related compliance roles.
• Bachelor’s degree from an accredited institution.
• U.S. citizen with current Secret clearance.
• Proven experience preparing or reviewing Assurance packages to ensure compliance with federal regulations.
• Experience conducting inspections and audits of HRPP stakeholders to verify regulatory compliance.
• Strong knowledge of federal, DoD, and Department of Navy (DON) regulations related to human subject research.
• Demonstrated ability to draft HRPP policies and guidance for IRBs, investigators, and institutional stakeholders.

Benefits

• Full-time employment with a competitive salary.
• Opportunity to work in a hybrid environment (up to 60% remote).
• Engagement with federal human research programs.
• Development of compliance tools and oversight processes.
• Work with a knowledgeable team in a critical compliance area.