Overview:
Reporting through the Virginia Health Sciences (VHS) Office of Research, the Clinical Trial Regulatory Specialist supports the efficient and compliant conduct of clinical trials by coordinating regulatory and operational activities across study teams, the IRB, and the Sponsored Programs Clinical Contracts Team. This position ensures alignment between clinical protocols, informed consent forms, and coverage analyses; oversees the regulatory use of the Clinical Trial Management System (CTMS); and provides education and training to research personnel. The Specialist plays a key role in promoting consistent documentation practices, regulatory readiness, and process integration to support institutional and sponsor requirements.
Responsibilities:

PREFERRED QUALIFICATIONS:

• Candidate should have familiarity with Good Clinical Practice (GCP)
• Certification in clinical research (e.g., Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) is a plus.
• Masters degree in related field.
• Familiarity with Clinical Trial Management Systems (e.g., Clinical Conductor) is preferred. Experience working with data management and analysis tools.
  Location : Location: US-VA-Norfol

• Performs other related duties as assigned to support clinical research operations, regulatory compliance, or institutional initiatives.
  Qualifications:
  Bachelor’s degree in health sciences, regulatory affairs, legal studies, or a related field is required.
  Minimum of 2–3 years of experience in clinical research administration, clinical trial management, or a related role, with demonstrated expertise in contract development, negotiation, or IRB regulatory affairs. Working knowledge of Medicare/Medical billing processes. Working knowledge with developing and managing clinical trial budgets and coverage analysis. Experience with institutional funding management and/or academic research foundations (e.g., ODURF). Familiarity with electronic IRB platforms such as IRBManager