UNIV - Research Study Coordinator - Hollings Cancer Center

Job Description Summary

Under general supervision of the Clinical Trials Office (CTO) and 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 the National Cancer Institute (NCI), investigator initiated and industry sponsored oncology trials at the Medical University of South Carolina (MUSC). Actively promotes and increases awareness of the clinical trial program within HCC, exercises judgment regarding proper study participant management.
Entity

Medical University of South Carolina (MUSC - Univ)
Worker Type

Employee
Worker Sub-Type

Research Grant
Cost Center

CC001332 HCC CTO Administration
Pay Rate Type

Hourly
Pay Grade

University-GEN
08
Pay Range

46,206.

- 78,540.000
Scheduled Weekly Hours

40
Responsibilities

35% Coordinates patient research related activities to accurately meet protocol requirements:
Ensure protocol compliance for study participants. Ensures database updates 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 participant, medical staff, nursing staff and ancillary hospital personnel.

Ensures that follow‑up requirements per protocol are carried out in order to assess for response to treatment. Works closely with clinical nurse staff to coordinate patient care to meet protocol standards. Consults with the investigator to assess study participant for response to protocol therapy including toxicity assessment and disease status. Coordinates and conducts activities associated with the preparation and shipment of protocol related samples within specified parameters.

Prepares, transports, and handles blood borne pathogens and other human specimens following OSHA guidelines. Enters and maintains both current and new study participant information into the clinical trials database. New patient enrollments and status updates are to be entered into the CTMS within 24 hours of the enrollment or status change. This includes Screening, Screen Failures, Consenting, Enrolling, Active on Treatment, Follow up, and Off study status.

New patient enrollments and status updates are to be entered/confirmed in EPIC within 24 hours of the enrollment and or status change. This includes Consented- in screening, Enrolled-Receiving treatment and/or intervention, Enrolled-follow up only, Lost to follow up, Screen failure and Completed. Research participant protocol‑related visits must be linked in EPIC prior to the encounter. 20% Assists investigators to identify, consent, screen, register/ enroll eligible patients to studies at Hollings Cancer Center:
Screens all patients at the Hollings Cancer Center (HCC) that have been newly diagnosed, have progressed, or experienced a recurrence to potentially be included into a clinical trial. Attends and actively participates in regularly scheduled multidisciplinary tumor boards, clinics, conferences, and any other forum where patients may be discussed. Documents and tracks all screening efforts per departmental guidelines. Establishes communication with physician investigators and care team regarding potential study participants.

Effective screening of HCC patient medical records requires knowledge of oncology terminology, medical terminology, disease specific staging and each clinical trial protocol eligibility criterion. Meets weekly with their clinical operations team to discuss…