Regulatory Affairs Coordinator - VESPER at The Henry M.… · Washington

Summary: The Henry M. Jackson Foundation for the Advancement of Military Medicine is a nonprofit organization dedicated to advancing military medicine. They are seeking a Regulatory Affairs Coordinator to assist in compliance for research programs related to human subjects and regulatory documentation management.

Responsibilities:
- 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

Required Qualifications:
- Bachelor's degree in a scientific, health‑related, or regulatory field
- Minimum of 0-2 years of experience
- Strong understanding of IRB processes, human subjects protection regulations, and HIPAA guidelines
- Ability to prepare and manage regulatory submissions with accuracy and attention to detail
- Strong organizational, documentation, and tracking skills
- Experience with research budget management, including issuing participant payments and coordinating study supplies purchases
- Ability to communicate effectively with investigators, IRB personnel, and multidisciplinary research teams
- Proficiency in electronic IRB systems, regulatory document management, and Microsoft Office tools
- Ability to work independently, manage multiple deadlines, and prioritize tasks in a fast‑paced research environment
- Must be a US Citizen
- Ability to obtain and maintain a T1/Public Trust background check
- Ability to obtain a Without compensation appointment with the DC VA Medical Center

Preferred Qualifications:
- Experience in clinical research regulatory affairs, IRB coordination, or research compliance
- Experience working with VA or federal IRB systems
- Certified as a Clinical Research Coordinator (CCRC), Clinical Research Associate (CCRA), and/or Clinical Research Professional (CCRP)

Required Skills: IRB processes, Human subjects protection regulations, HIPAA guidelines, Regulatory submissions management, Research budget management, Participant payments processing, Study supplies procurement, Electronic IRB systems, Regulatory document management, Microsoft Office, Clinical Research Coordinator (CCRC) certification, Clinical Research Associate (CCRA) certification, Clinical Research Professional (CCRP) certification

Benefits: Comprehensive suite of benefits focused on your health and well-being, Medical, dental, and vision coverage, Health savings and retirement plans