UNIV - RHN Research Study Coordinator - Hollings Cancer Center

Entity: Medical University of South Carolina (MUSC - Univ)

Pay Range: $45,300.00 - $61,100.00 - $77,000.00 per year

Scheduled Weekly Hours: 40

Work Shift: Full-time, split between Orangeburg and Charleston

About the role

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 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 MUSC’s community sites and exercises judgment regarding proper study participant management.

Responsibilities

• Coordinates patient research-related activities (35%):
  • Ensure protocol compliance for study participants.
  • Update databases to reflect accurate patient status using SharePoint, Clinical Data Center (CDC), and clinical trial management system (CTMS).
  • Provide protocol-specific information to physicians, primary nurses, and patients.
  • Coordinate clinical work-up to determine patient eligibility, treatment plans, and required follow-up with study participants, medical staff, nursing staff, and ancillary hospital personnel.
  • Ensure follow-up requirements per protocol are carried out to assess response to treatment.
  • Work closely with clinical nurse staff to coordinate patient care to meet protocol standards.
  • Consult with investigators to assess study participants for response to protocol therapy, including toxicity assessment and disease status.
  • Coordinate and conduct activities associated with the preparation and shipment of protocol-related samples within specified parameters, following OSHA guidelines for bloodborne pathogens and human specimens.
  • Enter and maintain current and new study participant information into 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).
  • Enter/confirm patient status updates in EPIC within 24 hours (e.g., Consented-in screening, Enrolled-Receiving treatment, Enrolled-follow-up only, lost to follow-up, Screen failure, Completed).
  • Link research participant protocol-related visits in EPIC prior to the encounter.
• Identify, consent, screen, and enroll eligible patients (20%):
  • Assist investigators in identifying and enrolling eligible patients for oncology studies at MUSC Orangeburg on behalf of Hollings Cancer Center.
  • Screen patients at MUSC Orangeburg being evaluated for cancer, newly diagnosed, progressed, or experiencing recurrence for potential inclusion in clinical trials.
  • Attend and 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.
  • Screen HCC patient medical records using knowledge of oncology terminology, medical terminology, disease-specific staging, and protocol eligibility criteria.
  • Meet regularly with the community site research team to discuss potential trial participants and plan clinic coverage needs.
  • Support research activities at MUSC main campus and HCC satellite locations under guidance from team lead coordinator(s) and program manager.
  • Participate in and support the informed consent process per departmental and institutional policy.
• Collect and submit research data (20%):
  • Timely and accurately collect and submit data to established research bases, including the National Cancer Institute, industry sponsors, and MUSC.
  • Ensure data quality and timely completion and submission of case report forms (CRFs) and queries.
  • Develop and implement an effective daily routine for retrieving data from local or outside medical records, completing CRFs, and addressing data queries.
  • Submit data according to sponsor-mandated time frames to ensure maximum accuracy.
  • Ensure source documentation is present in the patient chart for CRF completion.
  • Complete visit-specific CRFs per sponsor requirements, including patient-reported outcome questionnaires, radiologic scans, reports, and staging tests.
  • Proactively plan, prioritize, and manage responsibilities to ensure timely and accurate data submission.
  • Collaborate with Data Coordinators for patient protocol visits, including adverse event logs, patient questionnaires, specimen pickup, and transporting study supplies.
  • Maintain workflows to identify data needs across multiple trials and disease groups, communicating data entry needs to the study team.
• Submit adverse events and regulatory documents (15%):
  • 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.
  • Proactively plan to ensure reports are comprehensive and submitted within allowable timeframes.
  • Submit regulatory documents to the Manager of Regulatory Compliance, including Adverse Event reports, protocol deviation reporting, protocol amendments, and sponsor correspondence.
  • Address and close outstanding items from sponsor monitoring visit letters within 4 weeks or by the monitor’s next site visit, whichever is earlier.
• Maintain protocol knowledge and support trial processes (10%):
  • Maintain a working knowledge of the region-specific trial portfolio and participate in disease focus group meetings to support trial start-up and maintenance of protocol amendments.
  • Present pertinent research-related data to research focus groups and individual investigators.
  • Maintain up-to-date protocol information, communication, and education for study and clinic personnel.
  • Assist in planning, implementing, and evaluating program expansion and new projects.
  • Contribute positively and professionally to working groups and meetings.
  • Initiate and organize meetings, prepare agendas, and discuss high-priority trials.
  • Present protocols to programs and assess patient population and trial feasibility.
  • 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 initial and amended roadmaps.
  • Complete amended roadmaps by the assigned date to ensure patient safety.

Requirements

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

Physical Requirements

• Ability to perform job functions in an upright position (Frequent: 2-6 hours per shift).
• Ability to perform job functions in a seated position (Frequent: 2-6 hours per shift).
• Ability to perform job functions while walking/mobile (Frequent: 2-6 hours per shift).
• Ability to work indoors (Continuous: 6-8 hours per shift).
• Ability to work outdoors in all weather and temperature extremes (Infrequent: 0-2 hours per shift).
• Ability to work in confined/cramped spaces (Infrequent: 0-2 hours per shift).
• Ability to perform job functions from kneeling positions (Infrequent: 0-2 hours per shift).
• Ability to squat and perform job functions (Infrequent: 0-2 hours per shift).
• Ability to perform 'pinching' operations (Infrequent: 0-2 hours per shift).
• Ability to fully use both hands/arms (Frequent: 2-6 hours per shift).
• Ability to perform repetitive motions with hands/wrists/elbows and shoulders (Frequent: 2-6 hours per shift).
• Ability to reach in all directions (Frequent: 2-6 hours per shift).
• Good finger dexterity (Continuous: 6-8 hours per shift).
• Ability to maintain tactile sensory functions (Continuous: 6-8 hours per shift).
• Ability to lift and carry 15 lbs., unassisted (Infrequent: 0-2 hours per shift).
• Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted (Infrequent: 0-2 hours per shift).
• Ability to push/pull objects, up to 15 lbs., unassisted (Infrequent: 0-2 hours per shift).
• Ability to maintain 20/40 vision, corrected, in one eye or with both eyes (Continuous: 6-8 hours per shift).
• Ability to see and recognize objects close at hand (Frequent: 2-6 hours per shift).
• Ability to see and recognize objects at a distance (Frequent: 2-6 hours per shift).
• Ability to determine distance/relationship between objects; depth perception (Frequent: 2-6 hours per shift).
• Good peripheral vision capabilities (Continuous: 6-8 hours per shift).
• Ability to maintain hearing acuity, with correction (Continuous: 6-8 hours per shift).
• Ability to perform gross motor functions with frequent fine motor movements (Frequent: 2-6 hours per shift).