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

Medical University of South Carolina•Charleston, SC

4d•$45,300 - $77,000•Onsite

About The Position

The Senior Clinical Research Coordinator is responsible for the day-to-day coordination, management, and execution of complex clinical research studies in accordance with Good Clinical Practice (GCP), institutional policies, and federal regulations. This role reflects a coordinator who can exercise discretion with limited oversight while coordinating assigned studies, supporting disease-specific research workflows, maintaining study data and documentation, preparing for sponsor monitoring and audit activities, and serving as a resource to less experienced coordinators. The position serves as a liaison between investigators, sponsors, research participants, families/caregivers, ancillary services, vendors, and regulatory partners to support safe, compliant, and high-quality study conduct. This position may require after-hours or weekend study visits for enrollment or protocol-required activities, and some travel may be required for investigator or sponsor meetings.

Requirements

A bachelor's degree
Three years of relevant program experience

Responsibilities

Independently coordinate assigned research protocols and oversee the clinical and operational activities required for successful study execution.
Screen and enroll participants; obtain informed consent; coordinate and conduct study visits per protocol; educate participants and families/caregivers; monitor and report adverse events, including preparation of serious adverse event reports; collect and process laboratory specimens; dispense or coordinate investigational product as applicable; review patient diaries; enter data; complete case report forms; and maintain accurate, organized, and compliant study documentation.
Support disease-specific research meetings and workflows to help identify target populations, raise awareness of active trials, and meet study enrollment goals.
Partner with investigators and program leadership to review inclusion/exclusion criteria, support participant identification, and develop practical workflows within disease populations to improve recruitment, screening, enrollment, and retention.
Independently maintain accurate and complete subject-level documentation for assigned studies.
Coordinate data management activities according to protocol requirements, regulatory standards, and institutional policies.
Collect, record, abstract, and submit study data within required timelines; support database design, implementation, updates, and integrity review; extract data from Epic or other approved systems; retrieve outside medical records when appropriate; maintain complete case files; and respond to data queries promptly.
Perform or coordinate protocol-required clinical procedures and specimen-related activities that require training or certification, which may include phlebotomy, sweat testing, spirometry, EKG, laboratory collection and processing, specimen preparation, shipping, and inventory tracking.
Support investigational product handling, dispensing coordination, accountability, and documentation at the protocol and subject level in accordance with the pharmacy manual, protocol requirements, and institutional policy.
Prepare for and support sponsor monitoring visits, internal audits, FDA or regulatory inspections, site initiation visits, closeout visits, and other study review activities as required.
Ensure monitors and auditors have appropriate access to study documents, source data, regulatory materials, databases, workspace, and other resources.
Communicate findings, requests, and responses to the PI and program leadership, and support timely resolution of queries, deficiencies, or follow-up items.
Prepare for and participate in study, program, disease-specific, sponsor, and team meetings.
Serve as a knowledgeable point of contact between sponsors, PIs, vendors, subcontractors, ancillary services, Investigational Drug Services Pharmacy, labs, imaging, NEXUS, MUSC Hospital services, and other partners.
Mentor and assist with training junior staff as needed, including shadowing opportunities, equipment/process training, and reinforcement of protocol-specific expectations.