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.

Regulatory and Operational Support

• Provides day-to-day regulatory support for clinical research studies, focusing on protocol documentation, IRB coordination, and startup readiness.
• Works closely with the SPA Clinical Contracts Team to monitor and update regulatory status in the Clinical Trial Management System (CTMS) throughout the study lifecycle, from initial submission through execution.
• Assists study teams in maintaining compliant regulatory records and ensures timely entry of study milestones and documentation.
• Reviews informed consent forms (ICFs) to ensure consistency with clinical trial agreements, particularly in areas such as subject injury, compensation, and confidentiality language.
• Performs cross-document review to align protocol, contract terms, and ICF content, helping to identify and resolve discrepancies prior to IRB submission.

• Serves as a liaison to study teams and sponsors on regulatory documentation matters, distinct from the financial and contracting responsibilities managed by the Clinical Contracts Team.

Coverage Analysis and Startup Alignment

• Works closely with study teams and principal investigators to prepare and interpret coverage analyses, identifying which procedures are billable to insurance versus the study sponsor based on CMS guidelines and applicable NCD/LCD determinations.
• Ensures alignment between the coverage analysis, informed consent, and budget assumptions to support accurate documentation prior to contract finalization.
• Collaborates with study teams to ensure internal budget development reflects the approved coverage analysis, providing the necessary foundation for subsequent sponsor negotiations by the Clinical Contracts Team.
• Supports protocol document review during study startup to ensure clarity and alignment across clinical, regulatory, and operational elements.

CTMS Oversight and Training

• Promotes and supports consistent use of the Clinical Trial Management System (CTMS) by clinical research teams, with an emphasis on study setup, milestone tracking, and regulatory documentation.
• Provides onboarding and ongoing training on CTMS functionality, IRB tracking workflows, and compliance documentation for research staff.
• Develops user guidance, templates, and process documentation to support consistent CTMS usage across departments.

• Leads educational efforts related to best practices in regulatory documentation and clinical trial operations, ensuring alignment with institutional policies and sponsor requirements.

Other Duties as Assigned

• Performs other related duties as assigned to support clinical research operations, regulatory compliance, or institutional initiatives.

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

Preferred Qualifications:

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