Regulatory Clinical Research Coordinator (CRC), Licensed or Non-Licensed, varying levels

Overview

The Division of Cardiovascular Medicine (Interventional Cardiology) at the University of Virginia’s School of Medicine is seeking Clinical Research Coordinators (CRC), licensed or non‑licensed, to join a dynamic, growing team of clinical research professionals. This position is open to applicants who meet the requirements of Clinical Research Coordinator 2, 3, and 4. The CRC will work closely with physicians, research staff, sponsors, the Institutional Review Board (IRB), and regulatory department staff to coordinate all regulatory aspects of clinical research from study start‑up through archiving of study records.

The Research Regulatory Coordinator leads, coordinates and oversees regulatory processes across multiple studies in different therapeutic cardiovascular disease areas and phases, in accordance with appropriate regulations, institutional policies, standard operating procedures (SOPs), study‑specific protocols, plans, and processes independently. Studies may be large, nationwide, or moderately complex, involving multiple sites and/or assessments and interventions.

This position works closely with world‑renowned principal investigators and other research team members during the life cycle of the trial. The incumbent is responsible for maintaining quality management of the trial portfolio and ensuring regulatory compliance across all studies.

• Oversee the entire lifecycle of clinical trials from initiation to close‑out.
• Manage regulatory activities for all stages of clinical trials for the assigned department.
• Prepare and submit regulatory documents to sponsors and IRBs. Work with the clinical research team to ensure submission documents are up‑to‑date.
• Ensure adherence to study protocols, Good Clinical Practice (GCP), and regulatory requirements.
• Maintain a working knowledge of all federal, state, and institutional guidelines regarding clinical trials. Provide guidance and training to research staff to ensure compliance with rules and regulations associated with clinical research studies.
• Facilitate the submission of regulatory documents to institutional review boards (IRBs) and other regulatory entities.
• Prepare and maintain all study‑related documentation, including informed consent documents, delegation of authority logs, training records, etc.
• Facilitate the use of eFlorence, ONCORE, CRConnect/2, and other UVA‑required programming.
• Complete industry registrations and study feasibility questionnaires, including receipt, tracking, and correspondence with sponsor/CRO/ARO.
• Monitor approval status of open studies by completing timely reviews and completing IRB renewals prior to expiration and communicating with sponsor on renewals.
• Maintain master files of all regulatory‑related documents – electronically and in hard copy.
• Assist in submission of Investigational New Drug (IND) applications, including amendments and reporting.
• Coordinate schedules of on‑site visits, including introductions, tours, EMR access and sponsor/CRO/ARO requests, and monitoring visits.

• Supervise and mentor junior CRCs and support staff in regulatory compliance and IRB guidelines.
• Provide training on study protocols, regulatory requirements, and best practices.
• Foster a collaborative and efficient team environment.

• Act as a key contact between the research team, study sponsors, regulatory bodies, and other stakeholders.
• Coordinate study meetings, including site initiation visits, monitoring visits, and audits.
• Communicate effectively with principal investigators and ensure they are kept informed of study progress and any issues that arise.

• Conduct routine quality checks to ensure compliance with regulatory standards.
• Assist in the preparation for and conduct of internal and external audits.
• Implement corrective action plans as necessary to address compliance issues.

• Regulatory Acumen
  :
  In‑depth knowledge of FDA regulations, ICH GCP guidelines, and state‑specific regulatory requirements.
• Technical Proficiency
  :
  Familiarity with electronic data capture systems, clinical trial management…