Regulatory Affairs Specialist; Part-Time- Clinical Trials; SCi

Join the HJF Team!

HJF is seeking a Regulatory Compliance Specialist - Clinical Trials 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 position will be in support of the Surgical Critical Care Initiative, USU Department of Surgery. The Surgical Critical Care Initiative (SC2i), funded by the Department of Defense was established in 2013. SC2i is a Uniformed Services University center that leverages legacy information from service members, and critically ill civilian and military patients to develop biomarker-driven clinical decision support tools (CDSTs) with the goal of improving patient clinical outcomes and reducing costs across the injury/disease cycle.

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.

• Leads the review of protocols, regulatory documentation, and other research activities to ensure compliance with relevant federal and local regulations and policies regarding research involving human subjects, laboratory animals, select agents, the use of multi-omics, and HIPAA.
• Maintains a regulatory and tracking database, including data entry, queries, and reports.
• Collaborates with research staff, Principal Investigators, CROs, clinical sites, and Institutional Review Boards to prepare, submit, and obtain approval for new research protocols and relevant agreements.
• Ensures required protocols are registered and maintained in clinical trials.gov.
• Maintains the department's research protocols and agreements, including all correspondence, and preparing and distributing reports related to the protocols. Works directly with various HJF Headquarter departments on preparation of data sharing/use agreements, material transfer agreements, CRADAs, etc.
• Provides necessary information for the protocols, such as clearance forms, data forms, rosters, and more. Additionally, prioritizes all administrative tasks to ensure that protocols are expedited in a timely manner.
• Maintains effective relationships with research staff, Principal Investigators, IRB regulatory personnel, SC2i consortium regulatory counterparts, CROs, and other key stakeholders to ensure continued scientific and operational functioning of assigned protocols.
• Supports, manages, and coordinates QMS activities related to manufacturing and laboratory compliance.
• Leads efforts in managing compliance and regulatory issues, and in preparing for research training activities for Principal Investigators and research personnel.
• Serves as regulatory support for the development of Clinical Decision Support Tools (CDST) and In Vitro Diagnostic (IVD) FDA-regulated clinical trials.
• Supports various clinical trial activities, including collaboration with regulatory consultants to ensure compliance with regulatory requirements.
• Prepares and manages all regulatory documentation for FDA submissions, including conducting pathway analyses and preparing Q‑Submissions, Pre‑IDE, and IDE applications, as well as other necessary documentation to facilitate the FDA approval process.
• May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.

• Bachelor's Degree is required.
• Minimum of 3‑5 years of experience required.

• Certified as a Clinical Research Coordinator (CCRC), Clinical Research Associate (CCRA), and/or Clinical Research Professional…