Regulatory Affairs Specialist - VESPER

• Prepare and submit IRB applications, amendments, continuing reviews, reportable events, and study closures.
• Lead Human Research Protections Office (HRPO) submission, review, and response processes, ensuring compliance with sponsor-specific requirements, timelines, and standards.
• Provide regular status updates to the PI and project leadership; surface risks and mitigation strategies proactively.
• Prepare study update materials that are necessary for meeting project milestone required by University partner and funding sponsor.
• Maintain a current regulatory binder including approvals, protocol versions, consent forms, training, and essential documents.
• Maintain study logs, personnel training records, and credentialing documentation.
• Coordinate communications with investigators, study teams, and IRB staff to facilitate timely approvals and minimize amendment delays.
• Maintain complete, accurate, and auditable records aligned with institutional, sponsor, and regulatory standards.
• Conduct periodic self-checks to prepare for audits/monitoring visits.
• Coordinate with sponsor monitors/auditors and respond to regulatory inquiries, deviations, and corrective actions.
• Administer participant payments, ensuring accuracy, timeliness, and proper documentation.
• Maintain participant payment logs, reconcile disbursements with study visit completion, and support audit readiness.
• Coordinate with study manager to track budgets, forecast spend rates and resolve discrepancies; generate periodic financial reports for PI and sponsor.
• Implement internal controls for payment workflows and handle escalations.
• Monitor study supply levels, track inventory, and initiate procurement of study materials and equipment.
• Serve as the study's primary point of contact with HJF for administrative, contractual, and financial processes.
• Support SOP development and process improvements to streamline regulatory and financial workflows.
• Coordinate internal approvals, ensure alignment with organizational policies, and support sponsor billing requirements.
• Perform other duties as assigned by the supervisor to support research compliance and regulatory operations.

Join the HJF Team!

HJF is seeking a Regulatory Affairs Specialist to assist in the compliance of HJF research programs with applicable local, state and federal regulations for human subjects research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA). This is the second Regulatory Affairs level in the series.

This position will be in support of the Complex Exposure Threats Center of Excellence (CETCE) at the VA Medical Center in Washington, DC. The Regulatory Affairs Coordinator will support the center's human subjects research portfolio focused on environmental exposures and health outcomes, by preparing, submitting, and managing regulatory documentation; ensuring compliance with institutional, federal, and sponsor requirements; and assisting with study budget and supply management. This role is responsible for Institution Review Board (IRB) submissions, informed consent oversight, regulatory documentation management, supply tracking, ongoing study compliance, supply inventory, and study budget oversight. The position works closely with investigators, study coordinators, and the DC VA medical center's IRB team to ensure timely approvals and efficient study operations.

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing, and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.