UNIV - Clinical Research Coordinator - Department of Medicine: Division of Pulmonary

Job Description Summary

The Clinical Research Coordinator (CRC) is responsible for the day‑to‑day coordination, management, and execution of clinical research studies in accordance with Good Clinical Practice (GCP), institutional policies, and federal regulations. The CRC serves as a key liaison between investigators, sponsors, research participants, and regulatory bodies to ensure clinical trials are conducted with the highest standards of integrity, safety, and compliance. The CRC will collaborate with the Clinical Research Program leadership, investigators, other staff, as well as external sponsors to support the advancement of medical knowledge and patient care.

This position may conduct study visits after hours and on weekends for enrollment into trials.

• 35% – Visit Coordination: Oversee the day‑to‑day clinical and operational activities required for the successful execution of research protocols. Ensure that all study procedures are conducted in strict accordance with the protocol, regulatory requirements, and institutional standards. Responsibilities include (but not limited to) obtaining informed consent, coordinating, and scheduling study visits, educating participants about study procedures, monitoring and reporting adverse events (including preparation of serious adverse event reports), collecting and processing laboratory specimens, dispensing investigational products, reviewing patient diaries, completing required study procedures, entering data, and completing case report forms, and maintaining accurate and compliant study documentation.
• 30% – Data Management: Independently maintain accurate and complete subject‑level documentation for all assigned studies. Coordinate data management activities in alignment with protocol requirements, regulatory standards, and institutional policies. Responsibilities include collecting, recording, and submitting study data within required timelines; providing database support (design, implementation, updates, and integrity review); extracting data from Epic; and responding to and resolving data queries promptly to ensure accuracy and compliance.
• 10% – Sponsor & Monitor
  
  Collaboration:
  
  Serve as the primary liaison between study sponsors, contract research organizations (CROs), and institutional teams to ensure smooth study conduct. Coordinate and host sponsor visits, including site initiation, monitoring, and closeout activities. Provide timely access to study documents, source data, and regulatory materials for review. Communicate proactively with sponsors regarding study progress, enrollment, protocol adherence, and data quality. Address and resolve monitoring findings or queries in a timely manner.
  
  Foster professional relationships with sponsors and monitors to support compliance, maintain audit readiness, and ensure the highest standards of research quality.
• 10% – Investigational Product & Specimen Management: Support the management and tracking of Investigational Products (IP) at both the protocol and subject levels, ensuring proper handling, dispensing, documentation, and accountability in accordance with regulatory requirements and institutional policies. Utilize required systems to maintain accurate IP records and compliance. Coordinate the collection, preparation, shipping, and inventory management of research specimens, while identifying opportunities for process improvements and providing guidance on best practices in specimen handling and documentation.
  
  May require some basic sample processing and handling.
• 10% – Communication: Prepare for and participate in team meetings. Serve as a primary liaison between Sponsor, PI, vendors, sub‑contracts, and ancillary services including Investigational Drug Services Pharmacy, labs, imaging, NEXUS, and MUSC Hospital services.
• 5% – Investigator Meetings & Other Duties as Assigned: Travel with the investigator to sponsor‑initiated meetings to review study protocols at initiation and to discuss clinical findings throughout the course of the trial. May be assigned other duties as needed to support the mission of the Clinical Research Program.

Minimum Requirements: A…