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

Regulatory Affairs Specialist (Part‑Time) – Clinical Trials (SC2i)

Join The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) as a Regulatory Affairs Specialist to support compliance of research programs with applicable regulations for human subjects, animal use, recombinant DNA, and HIPAA, in partnership with the Surgical Critical Care Initiative (SC2i).

• Lead 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.
• Maintain a regulatory and tracking database, including data entry, queries, and reports.
• Collaborate 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.
• Ensure required protocols are registered and maintained in clinical trials.gov.
• Maintain the department’s research protocols and agreements, including all correspondence, and prepare and distribute reports related to the protocols. Work directly with various HJF Headquarter departments on preparation of data sharing/use agreements, material transfer agreements, CRADAs, etc.
• Provide necessary information for the protocols, such as clearance forms, data forms, rosters, and more, and prioritize all administrative tasks to ensure that protocols are expedited in a timely manner.
• Maintain 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.
• Support, manage, and coordinate QMS activities related to manufacturing and laboratory compliance.
• Lead efforts in managing compliance and regulatory issues, and in preparing for research training activities for Principal Investigators and research personnel.
• Serve as regulatory support for the development of Clinical Decision Support Tools (CDST) and In Vitro Diagnostic (IVD) FDA‑regulated clinical trials.
• Support various clinical trial activities, including collaboration with regulatory consultants to ensure compliance with regulatory requirements.
• Prepare and manage 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 and may include attendance of and participation in required training for the role.

• Education and Experience:
  
  Bachelor’s Degree is required;
  Minimum of 3–5 years of experience required.
• Licenses and
  
  Certifications:
  
  Certified as a Clinical Research Coordinator (CCRC), Clinical Research Associate (CCRA), and/or Clinical Research Professional (CCRP) preferred.
• Required Knowledge, Skills, and Abilities:
  • Knowledge of federal and local regulations and policies pertinent to research involving human subject, recombinant DNA, and HIPAA.
  • Excellent communication and writing skills, interpersonal and organizational skills.
  • Must be a self‑starter and be able to work independently; must be able to multi‑task; ability to utilize computer applications packages, such as MS Word, Excel, PowerPoint, Adobe Acrobat Pro, Google Docs, Google Drive and E‑mail.
  • Ability to prioritize and manage workload effectively; ability to multi‑task effectively; ability to function effectively as part of a team.
  • Ability to identify and research problems/issues thoroughly and use discerning judgment in problem solving for organization, management, and scientific issues using a significant degree of qualitative, quantitative and analytical skill.
  • Outstanding English writing skills.
  • Regulatory experience supporting FDA‑regulated clinical trials is necessary. Strong motivation to learn about FDA‑regulated clinical trial preparation and tracking required.
  • Role is distinct from clinical trial…