UNIV - Lead Clinical Research Coordinator - Department of Medicine: Division of Pulmonary
About The Position
The Lead Clinical Research Coordinator (CRC) will focus primarily on one disease area, serving as the disease-area expert and overseeing the related research portfolio. The role involves overseeing the day-to-day clinical and operational activities for research protocols, ensuring strict adherence to protocol, regulatory requirements, and institutional standards. This includes obtaining informed consent, coordinating study visits, educating participants, monitoring adverse events, collecting specimens, dispensing investigational products, entering data, and maintaining study documentation. The Lead CRC also acts as a liaison between sponsors, PIs, vendors, and various hospital services, serves as the database expert, supervises and mentors junior staff, and creates recruitment plans. The position is with the Medical University of South Carolina (MUSC) in the Department of Medicine, Division of Pulmonary.
Requirements
- A bachelor's degree
- Two years of relevant program experience
Responsibilities
- Provides oversight as lead of a specific disease portfolio, working with Principal Investigators and Program Leadership to ensure goals are met and tracking projects to meet timelines.
- Troubleshoots any hurdles that come up and develops research-based workflows for projects within the clinics for the assigned disease.
- Onboards new projects to the disease portfolio by working with Program Leadership on start-up activities and runs portfolio team meetings with assigned staff.
- Identifies staffing needs for the disease portfolio and serves as the primary point of contact with sponsors and CROs.
- Oversees the day-to-day clinical and operational activities required for the successful execution of research protocols, ensuring adherence to protocol, regulatory requirements, and institutional standards.
- Obtains informed consent, coordinates and schedules study visits, educates participants about study procedures, monitors and reports adverse events, collects and processes laboratory specimens, dispenses investigational products, reviews patient diaries, completes required study procedures, enters data, and completes case report forms.
- Maintains accurate and compliant study documentation.
- Prepares for and participates in team meetings, serving as a primary liaison between Sponsor, PI, vendors, sub-contracts, and ancillary services.
- Ensures connection between services is working and troubleshoots as needed for projects.
- Acts as the database expert for the Program, ensuring all databases are up to date and current by meeting required timelines, and provides training, support, and guidance for databases.
- Supervises and mentors junior clinical research staff, providing disease-specific training and orienting them to workflows for the disease portfolio.
- Trains and acts as a resource on job-related tasks and research best practices, working alongside Program Leadership to ensure junior staff conduct trials within guidance.
- Creates a recruitment plan in compliance with federal regulations and institutional policies.
- Prepares materials to report research progress back to Program leadership and the PI.
- Organizes and coordinates community outreach programs and patient support groups as needed.
- Participates in external community and patient programs as requested to advertise research.
- Performs other duties as assigned by program leadership and serves as back-up to other staff as needed in the Program.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
