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

Medical University of South Carolina•Charleston, SC

3d•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 managing the day-to-day clinical and operational activities for research protocols, ensuring adherence to protocol, regulatory requirements, and institutional standards. The Lead CRC will also act as a database expert, prepare for and participate in team meetings, supervise and mentor junior staff, and create recruitment plans. Additionally, they will organize community outreach programs and serve as a backup to other staff as needed.

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 ensure timelines are met.
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 staff assigned to the area.
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 strict adherence to the protocol, regulatory requirements, and institutional standards.
Obtains informed consent, coordinates and schedules study visits, educates participants about study procedures, monitors and reports adverse events (including preparation of serious adverse event reports), collects and processes laboratory specimens, dispenses investigational products, reviews patient diaries, completes required study procedures, enters data, and completes case report forms, and maintains accurate and compliant study documentation.
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 as needed for databases.
Prepares for and participates in team meetings and 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 troubleshoots as needed for projects.
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 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.
Performs other duties as assigned by program leadership and serves as back-up to other staff as needed in the Program.