UNIV - RHN Research Study Coordinator - Hollings Cancer Center

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

Responsibilities

• 35% Coordination of Patient Research Activities:
  • Coordinates patient research activities to accurately meet protocol requirements and ensure protocol compliance for study participants.
  • Ensures database updates reflect accurate patient status using tools such as SharePoint, Clinical Data Center (CDC), and the clinical trial management system (CTMS).
  • Provides protocol-specific information to physicians, primary nurses, and patients.
  • Coordinates clinical work-ups to determine patient eligibility, treatment plans, and required follow-ups with study participants, medical staff, nursing staff, and ancillary hospital personnel.
  • Ensures follow-up requirements per protocol are carried out to assess response to treatment.
  • Works closely with clinical nurse staff to coordinate patient care to meet protocol standards.
  • Consults with investigators to assess study participants 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, following OSHA guidelines for handling bloodborne pathogens and other human specimens.
  • Enters and maintains current and new study participant information into the clinical trials database, ensuring updates are made within 24 hours of enrollment or status changes (e.g., Screening, Screen Failures, Consenting, Enrolling, Active on Treatment, Follow-up, Off study).
  • Confirms updates in EPIC within 24 hours, including Consented-in screening, Enrolled-Receiving treatment/intervention, Enrolled-follow-up only, lost to follow-up, Screen failure, and Completed.
  • Links research participant protocol-related visits in EPIC prior to the encounter.
• 20% Patient Identification and Enrollment:
  • Assists investigators in identifying, consenting, screening, registering, and enrolling eligible patients for oncology studies at MUSC Florence on behalf of Hollings Cancer Center.
  • Screens all patients at MUSC Florence being evaluated for cancer, newly diagnosed, progressed, or experiencing recurrence for potential inclusion in clinical trials.
  • Actively participates in multidisciplinary tumor boards, clinics, conferences, and other forums where patients may be discussed.
  • Documents and tracks all screening efforts per departmental guidelines.
  • Establishes communication with physician investigators and care teams regarding potential study participants.
  • Effectively screens HCC patient medical records using knowledge of oncology terminology, medical terminology, disease-specific staging, and protocol eligibility criteria.
  • Meets regularly with the community site research team to discuss potential trial participants and plan clinic coverage needs.
  • Supports research activities at MUSC main campus and HCC satellite locations under the guidance of team lead coordinators and program managers.
  • Participates in and supports the informed consent process per departmental and institutional policies.
• 20% Data Collection and Submission:
  • Timely and accurately collects and submits data to established research bases, including the National Cancer Institute, industry sponsors, and MUSC.
  • Ensures data quality and timely completion and submission of case report forms (CRFs) and queries.
  • Develops and implements an effective daily routine for retrieving data from local or outside medical records, completing CRFs, and addressing data queries.
  • Ensures data is submitted according to sponsor-mandated time frames with maximum accuracy.
  • Verifies source documentation is present in patient charts for CRF completion.
  • Completes visit-specific CRFs per sponsor requirements, including patient-reported outcome questionnaires, radiologic scans, reports, and staging tests.
  • Proactively plans, prioritizes, and manages responsibilities to ensure timely and accurate data submission.
  • Collaborates with Data Coordinators on patient protocol visits, including adverse event logs, patient questionnaires, specimen pickup, and transporting study supplies.
  • Maintains workflows to identify data needs across multiple trials and disease groups, communicating data entry needs to the study team.
• 15% Adverse Event and Regulatory Reporting:
  • 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 within the Clinical Trials Office, MUSC, and study sponsors.
  • Proactively plans to ensure reports are comprehensive and submitted within allowable timeframes.
  • Submits regulatory documents to the Manager of Regulatory Compliance, including Adverse Event reports, protocol deviation reporting, protocol amendments, sponsor correspondence, and other documents requiring IRB review/submission.
  • Submits non-regulatory documents such as screening logs and database updates.
  • Reports protocol deviations to the clinical trials office regulatory unit per departmental processes.
  • Addresses and closes outstanding items from sponsor monitoring visit letters within 4 weeks or by the monitor’s next site visit, whichever is earlier.
• 10% Protocol Maintenance and Program Support:
  • Maintains a working knowledge of the region-specific trial portfolio and participates in disease focus group meetings to support trial start-up and protocol amendments.
  • Presents pertinent research-related data to research focus groups and individual investigators.
  • Maintains up-to-date protocol information and educates study and clinic personnel.
  • Assists in planning, implementing, and evaluating program expansion and new projects.
  • Contributes professionally to working groups and meetings, initiating and organizing meetings, and preparing agendas.
  • Discusses high-priority trials and presents protocols to programs, assessing patient population and trial feasibility.
  • Reviews new protocols during the "In Approval Process-Step 1," completes initial roadmap submissions by designated timelines, and obtains study-specific credentialing.
  • Collaborates with CTO nurse managers to develop and amend roadmaps, ensuring patient safety.
  • Completes roadmap submissions by assigned due dates, ensuring accuracy in treatment arms, hold and call parameters, and dosing modifications per protocol guidelines.

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 a 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).

Pay

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

Schedule

• Scheduled weekly hours: 40
• Work shift: Day shift (details not specified).