UNIV - Research Study Coordinator - Hollings Cancer Center

Medical University of South Carolina•Charleston, SC

About The Position

Under general supervision of the Clinical Trials Office (CTO) and the specific disease group Program Manager within the Clinical Operations Unit, the Research Study Coordinator coordinates, establishes, and supervises complex research protocols at Hollings Cancer Center (HCC). The role supports the effective integration of National Cancer Institute, investigator-initiated, and industry-sponsored oncology trials at the Medical University of South Carolina (MUSC). The coordinator promotes awareness of the clinical trial program within HCC and exercises judgment in managing study participants. The coordinator works with investigators, physicians, nurses, patients, data coordinators, and other hospital personnel to identify and enroll eligible participants, coordinate protocol-related care and follow-up, maintain accurate study records, and submit research data and safety reports on time. The position also supports trial start-up and maintenance, including protocol reviews, roadmaps, amendments, and communication and education for study and clinic personnel.

Requirements

Bachelor's degree.
Two years of relevant program experience.
Knowledge of oncology and medical terminology, disease-specific staging, and clinical trial protocol eligibility criteria is needed to screen HCC patient records effectively.
Ability to meet the listed physical requirements, including frequent seated, upright, and mobile work; continuous indoor work; fine motor activity and finger dexterity; and occasional lifting, carrying, pushing, or pulling of objects up to 15 pounds.

Responsibilities

Coordinate patient research activities and ensure protocol compliance, accurate participant status, and timely updates in the clinical trials management system and EPIC.
Provide protocol-specific information to physicians, nurses, patients, and other care team members; coordinate eligibility work-ups, treatment plans, follow-up, and assessment of treatment response, toxicity, and disease status.
Coordinate and conduct preparation and shipment of protocol-related samples, and handle human specimens in accordance with OSHA guidelines.
Enter and maintain participant information in study databases and ensure required enrollment and status updates are made in the clinical trials management system and EPIC within 24 hours.
Assist investigators in identifying, consenting, screening, registering, and enrolling eligible patients; document and track screening efforts and participate in the informed consent process.
Screen HCC patients for potential clinical trial eligibility, attend multidisciplinary tumor boards, clinics, and conferences, and communicate with investigators and care teams about potential participants.
Collect and submit accurate research data, complete case report forms and queries, maintain source documentation, and meet sponsor-specific submission timelines.
Collaborate with Data Coordinators on protocol visits, adverse event logs, patient questionnaires, specimen collection, and study supplies.
Submit adverse events, serious adverse events, protocol deviations, and other reportable events to sponsors, the NCI, IRB, DSMC, and other required entities within applicable timeframes.
Prepare CTO-required and sponsor-specific reports, submit regulatory documents to the Manager of Regulatory Compliance, and address outstanding sponsor monitoring items within required deadlines.
Maintain working knowledge of disease-specific trial portfolios and participate in focus group meetings to support trial start-up and protocol maintenance.
Present research information and protocols to focus groups and investigators; assess patient populations and trial feasibility; and maintain current protocol information and educate study and clinic personnel.
Assist with program expansion and new projects, contribute to working groups, organize meetings and agendas, and discuss high-priority trials.
Review new protocols during the approval process, complete initial and amended roadmap submissions by assigned deadlines, obtain protocol-specific credentialing, and ensure roadmaps accurately reflect study assessments, treatment arms, safety parameters, and dosing modifications.
Support research activities at MUSC main campus and HCC satellite locations, arranging coverage in advance as needed.