UNIV - Research Study Coordinator - Hollings Cancer Center

UNIV - Research Study Coordinator - Hollings Cancer Center

Job Summary

Under general supervision of the Clinical Trials Office (CTO) and a specific disease group Program Manager within the Clinical Operations Unit, this position coordinates, establishes, and supervises complex research protocols at the Hollings Cancer Center (HCC) to efficiently and effectively integrate National Cancer Institute (NCI), investigator‑initiated and industry‑sponsored oncology trials at the Medical University of South Carolina (MUSC). The role actively promotes and increases awareness of the clinical trial program within HCC and exercises judgment regarding proper study participant management.

• 35% Coordinates patient research related activities to accurately meet protocol requirements. Ensures protocol compliance for study participants; updates database to reflect accurate patient status; utilizes office tools including SharePoint, Clinical Data Center (CDC), and clinical trial management system (CTMS). Provides protocol‑specific information to physicians, primary nurses, and patients; coordinates the clinical work‑up to determine patient eligibility; coordinates treatment plan and required follow‑up with study participants, medical staff, nursing staff, and ancillary hospital personnel;
  
  ensures follow‑up requirements per protocol are carried out; works closely with clinical nurse staff; consults with investigator on participant response to protocol therapy including toxicity assessment and disease status; coordinates activities associated with the preparation and shipment of protocol‑related samples; prepares, transports, and handles blood borne pathogens and other human specimens following OSHA guidelines; enters and maintains current and new study participant information into the clinical trials database;
  
  new patient enrollments and status updates entered into the CTMS and EPIC within 24 hours of enrollment or status change.
• 20% Assists investigators to identify, consent, screen, register/enroll eligible patients to studies at Hollings Cancer Center. Screens all patients newly diagnosed, progressed, or recurred for potential inclusion; attends multidisciplinary tumor boards, clinics, conferences; documents and tracks all screening efforts; establishes communication with physician investigators and care team; conducts informed consent process per departmental and institutional policy.
• 20% Timely and accurately collects and submits data to established research bases including the National Cancer Institute, industry sponsors, and MUSC. Ensures data quality, completes case report forms (CRFs) and queries, submits CRFs per sponsor requirements, manages source documentation, collaborates with Data Coordinators, and maintains workflows for data entry across multiple trials.
• 15% Timely and accurately submits adverse events, serious adverse events, and other reportable events to the NCI, sponsors, IRB, and DSMC per federal guidelines and institutional policies. Prepares and submits CTO‑required and sponsor‑specific initial and follow‑up reports; adheres to reporting requirements; ensures timely reporting of adverse events, protocol deviations, screening logs, database updates, and regulatory documents.
• 10% Maintains working knowledge of disease‑specific trial portfolio and participates in disease focus group meetings to support trial start‑up process for new studies and maintenance of protocol amendments. Presents research data to focus groups and investigators; maintains up‑to‑date protocol information; assists in planning, implementing, and evaluating program expansion and new projects; collaborates with CTO nurse managers on initial roadmap submissions and amended roadmaps.

A bachelor's degree and two years of relevant program experience.

Continuous—6‑8 hours shift;
Frequent—2‑6 hours shift;
Infrequent—0‑2 hours shift. Must be able to perform job functions in upright, seated, walking/mobile positions; work indoors and outdoors (weather/temperature extremes); handle confined spaces; start/finish lifts up to 15 lbs.; reach in all directions; use both…