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

Job Description Summary

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.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type​

Research Grant

Cost Center

CC000974 COM DOM PULM General CC

Pay Rate Type

Hourly

Pay Grade

University-GEN08

Pay Range

45,300.00 - 61,100.00 - 77,000.000

Scheduled Weekly Hours

40

Work Shift

Job Description

Job Duties:

30% - Advanced Visit Coordination & Study Execution: Independently coordinate assigned research protocols and oversee the clinical and operational activities required for successful study execution. Responsibilities include screening and enrolling participants; obtaining informed consent; coordinating and conducting study visits per protocol; educating participants and families/caregivers; monitoring and reporting adverse events, including preparation of serious adverse event reports; collecting and processing laboratory specimens; dispensing or coordinating investigational product as applicable; reviewing patient diaries; entering data; completing case report forms; and maintaining accurate, organized, and compliant study documentation.
 

15% - Recruitment, Disease-Specific Workflow & Enrollment Strategy: 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.

15% - Data Management & Database Support: Independently maintain accurate and complete subject-level documentation for assigned studies. Coordinate data management activities according to protocol requirements, regulatory standards, and institutional policies. Responsibilities include collecting, recording, abstracting, and submitting study data within required timelines; supporting database design, implementation, updates, and integrity review; extracting data from Epic or other approved systems; retrieving outside medical records when appropriate; maintaining complete case files; and responding to data queries promptly.

15% - Specialized Clinical Procedures, Investigational Product & Specimen Management: 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.

15% - Sponsor, Monitor & Audit Readiness: 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.

10% - Communication, Team Leadership, Training & Mentoring: 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 Ph