Job Description:
• Serve as the first point of contact for communications between internal and external parties
• Receive and review complaints and incident reports for completeness, accuracy, participant safety concerns, and regulatory significance
• Provide preliminary assessments to agency leadership
• Draft correspondence, information requests, case summaries, briefing materials, and status reports
• Communicate with research institutions, IRB personnel, investigators, complainants, and government officials
• Request and collect information for compliance evaluations
• Present analyses and recommendations to supervisors and compliance review teams
• Participate in internal case review meetings and support leadership reporting
• Develop reports, communication logs, trackers, briefing decks, and training materials
• Track case status, milestones, correspondence, and follow-up activities
• Maintain records supporting transparency, quality assurance, and audit readiness
• Ensure deliverables meet quality, format, content, and accessibility standards
• Monitor and communicate institutional corrective actions and compliance resolutions
• Analyze research documentation, IRB records, investigator information, and institutional responses
• Contribute to processes and procedures that improve team effectiveness and efficiency
• Execute assignments independently under general direction and keep the supervisor updated
• Perform other job-related duties as assigned
Requirements:
• Master's degree in public health, clinical research, health sciences, biomedical sciences, regulatory affairs, law, public administration, or a related field
• 8+ years relevant experience; additional education substitutes for experience
• Experience related to human subjects research protections and regulatory compliance
• Experience reviewing or supporting compliance activities related to human subjects research
• Experience working with Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), research compliance offices, or regulatory oversight organizations
• Knowledge of federal regulations governing human subjects research, including 45 CFR 46 (Common Rule)
• Experience evaluating research protocols, incident reports, complaints, audit findings, or compliance documentation
• Experience preparing written analyses, regulatory summaries, reports, or compliance correspondence
• Experience managing sensitive information and maintaining detailed records accurately
• Basic knowledge of project management software such as Microsoft Planner, Microsoft Project, Asana, and Smartsheet
• Exceptional attention to detail, ability to execute instructions, and commitment to quality and compliance
• Intermediate experience with Microsoft Office productivity software and collaboration tools such as Microsoft Teams and SharePoint
• Advanced degree preferred
• Certificates in project management, CIP (Certified IRB Professional), CCRP, CHRC, or related research compliance credential recommended
• Foundational technical writing knowledge
• Basic knowledge of AI tools, including limitations, risks, and applications to project management tasks
• Experience in academic medical centers, research institutions, federal agencies, or compliance oversight organizations
• Familiarity with electronic compliance or case management systems and document management tools
• Public Trust clearance
Benefits:
• Competitive pay
• Exceptional benefits
• Flexible work options that support your lifestyle and professional growth
• Meaningful opportunities to support an important public health mission