UNIV - RHN Research Study Coordinator - Hollings Cancer Center

Under general supervision of the Clinical Trials Office (CTO) and Assistant Director of Community Site Research within the Hollings Cancer Center, this position coordinates, establishes, and supervises complex research protocols at MUSC Orangeburg to efficiently and effectively integrate National Cancer Institute (NCI), investigator-initiated, and industry-sponsored oncology trials at the Medical University of South Carolina (MUSC). This role will be split between Orangeburg and Charleston.

Responsibilities

• 35% Coordination of patient research activities:
  • Ensure protocol compliance for study participants and accurate database updates reflecting patient status.
  • Utilize tools including SharePoint, Clinical Data Center (CDC), and clinical trial management system (CTMS).
  • Provide protocol-specific information to physicians, nurses, and patients.
  • Coordinate clinical work-ups to determine patient eligibility, treatment plans, and follow-up with medical staff and patients.
  • Ensure follow-up requirements per protocol are carried out to assess treatment response.
  • Work closely with clinical nurse staff to meet protocol standards.
  • Consult with investigators to assess study participants for response to protocol therapy, including toxicity and disease status.
  • Coordinate preparation and shipment of protocol-related samples following OSHA guidelines.
  • Enter and maintain study participant information in the clinical trials database and CTMS within 24 hours of enrollment or status change (e.g., Screening, Screen Failures, Consenting, Enrolling, Active on Treatment, Follow-up, Off study).
  • Update and confirm patient status in EPIC within 24 hours (e.g., Consented, Enrolled, Follow-up, Lost to follow-up, Screen failure, Completed).
  • Link research participant protocol-related visits in EPIC prior to the encounter.
• 20% Patient identification and enrollment:
  • Assist investigators in identifying, consenting, screening, registering, and enrolling eligible patients for oncology studies at MUSC Orangeburg.
  • Screen patients being evaluated for cancer, newly diagnosed, progressed, or with recurrence for potential inclusion in clinical trials.
  • Actively participate in multidisciplinary tumor boards, clinics, conferences, and other forums where patients may be discussed.
  • Document and track all screening efforts per departmental guidelines.
  • Establish communication with physician investigators and care teams regarding potential study participants.
  • Support research activities at MUSC main campus and HCC satellite locations under guidance from team leads and program managers.
  • Participate in the informed consent process per departmental and institutional policies.
• 20% Data collection and submission:
  • Timely and accurately collect and submit data to research bases including the NCI, industry sponsors, and MUSC.
  • Ensure data quality and timely completion/submission of case report forms (CRFs) and queries.
  • Develop and implement an effective daily routine for data retrieval, CRF completion, and addressing data queries.
  • Submit data according to sponsor-mandated time frames with maximum accuracy.
  • Ensure source documentation is present in patient charts for CRF completion.
  • Complete visit-specific CRFs per sponsor requirements, including patient-reported outcomes, radiologic scans, and staging tests.
  • Collaborate with Data Coordinators for protocol visits, adverse event logs, patient questionnaires, specimen pickup, and transporting study supplies.
  • Maintain workflows to identify data needs across multiple trials and disease groups.
• 15% Adverse event and regulatory reporting:
  • Timely and accurately submit Adverse Events, Serious Adverse Events, and other reportable events to the NCI, sponsors, IRB, and DSMC per federal guidelines and institutional policies.
  • Prepare and submit CTO-required and sponsor-specific initial and follow-up reports.
  • Adhere to reporting requirements within the Clinical Trials Office, MUSC, and study sponsors.
  • Submit regulatory documents to the Manager of Regulatory Compliance, including Adverse Event reports, protocol deviations, and new protocol documents (e.g., amendments, sponsor correspondence).
  • Address and close outstanding items from sponsor monitoring visits within 4 weeks or by the monitor’s next site visit, whichever is earlier.
• 10% Protocol knowledge and trial support:
  • Maintain working knowledge of region-specific trial portfolios and participate in disease focus group meetings.
  • Support trial start-up processes for new studies and maintenance of protocol amendments.
  • Present research-related data to focus groups and investigators.
  • Maintain up-to-date protocol information and educate study/clinic personnel.
  • Assist in planning, implementing, and evaluating program expansion and new projects.
  • Contribute to working groups and meetings, organize agendas, and discuss high-priority trials.
  • Review new protocols during the "In Approval Process-Step 1," complete initial roadmap submissions by designated timelines, and obtain study-specific credentialing.
  • Collaborate with CTO nurse managers to develop and amend roadmaps as needed.

Requirements

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

Physical Requirements

• Ability to perform job functions in an upright, seated, or walking/mobile position (Frequent).
• Ability to work indoors continuously and outdoors infrequently in all weather and temperature extremes.
• Ability to work in confined/cramped spaces, kneel, squat, and perform pinching operations (Infrequent).
• Ability to fully use both hands/arms, perform repetitive motions, and reach in all directions (Frequent).
• Good finger dexterity and tactile sensory functions (Continuous).
• Ability to lift, lower, push, or pull objects up to 15 lbs., unassisted (Infrequent).
• Ability to maintain 20/40 vision, corrected, in one or both eyes, including close, distance, depth perception, and peripheral vision (Continuous/Frequent).
• Ability to maintain hearing acuity, with correction (Continuous).
• Ability to perform gross motor functions with frequent fine motor movements (Frequent).

Pay

Pay range: $45,300.00 - $61,100.00 - $77,000.00 per year (hourly).

Schedule

Scheduled weekly hours: 40.