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

Medical University of South Carolina • Charleston, SC

1d • $52,100 - $88,600 • Onsite

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. This role involves overseeing day-to-day clinical and operational activities for research protocols, ensuring strict adherence to protocol, regulatory requirements, and institutional standards. The Lead CRC will also act as the database expert, prepare for and participate in team meetings, and supervise and mentor junior clinical research staff. Additionally, they will create recruitment plans, prepare progress reports, and organize community outreach programs.

Requirements

• A bachelor's degree
• Two years of relevant program experience

Responsibilities

• Provides oversight as lead of a specific disease portfolio. Works with Principal Investigators and Program Leadership to ensure that disease portfolio is meeting goals. Tracks projects to ensure timelines are met. Troubleshoots any hurdles that come up. Develops research-based workflows for projects within the clinics for assigned disease. Onboards new projects to the disease portfolio by working with Program Leadership on start-up activities. Runs portfolio team meetings with staff assigned to the area. Identifies staffing needs for the disease portfolio. Serves as primary point of contact with sponsors and CROs.
• 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 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.
• Acts as the database expert for the Program by ensuring that all databases are up to date and current by meeting required timelines. Also provides training, support, and guidance as needed for databases.
• Prepares for and participates in team meetings. Serves 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. Ensures connection between services is working and troubleshoot as needed for projects.
• Supervise and mentor junior clinical research staff. Provides disease specific training to junior staff and orients them to workflows for the disease portfolio. Trains and acts as resource on job related tasks and research best practices. Works alongside the Program Leadership to ensure junior staff are conducting 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.
• Other duties as assigned by the program leadership. Will serve as back-up to other staff as needed in the Program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level