UNIV - Research Study Coordinator - Hollings Cancer Center

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 and exercises judgment regarding proper study participant management.

Responsibilities

• 35% Coordinates patient research-related activities
  • Ensures protocol compliance for study participants and accurate database updates reflecting 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 clinical work-up to determine patient eligibility, treatment plans, and required follow-up 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.
  • Prepares, transports, and handles bloodborne pathogens and other human specimens following OSHA guidelines.
  • Enters and maintains current and new study participant information into the clinical trials database, ensuring updates within 24 hours of enrollment or status change (e.g., Screening, Screen Failures, Consenting, Enrolling, Active on Treatment, Follow-up, Off study).
  • Confirms new patient enrollments and 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).
  • Links research participant protocol-related visits in EPIC prior to the encounter.
• 20% Assists investigators in identifying, consenting, screening, registering, and enrolling eligible patients
  • Screens all patients at HCC who are newly diagnosed, have progressed, or experienced a 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.
  • Requires knowledge of oncology terminology, medical terminology, disease-specific staging, and protocol eligibility criteria.
  • Meets weekly with the clinical operations 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 coordinator(s) and program manager.
  • Participates in and supports the informed consent process per departmental and institutional policy.
• 20% Timely and accurate data collection and submission
  • Ensures data quality and timely completion and submission of case report forms (CRFs) and queries to research bases, including the National Cancer Institute, industry sponsors, and MUSC.
  • Develops and implements an effective daily routine for data retrieval, completion of CRFs, and addressing data queries.
  • Ensures data submission according to sponsor-mandated time frames for maximum accuracy.
  • Verifies source documentation is present in the patient chart 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 of multiple trials within disease groups and communicates 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 comprehensive reporting within allowable timeframes.
  • Submits regulatory documents to the Manager of Regulatory Compliance, including Adverse Event reports, protocol deviations, and new protocol documents (e.g., amendments, sponsor correspondence).
  • 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 trial start-up support
  • Maintains working knowledge of disease-specific trial portfolios and participates in disease focus group meetings.
  • Presents research-related data to focus groups and individual investigators.
  • Maintains up-to-date protocol information, communication, and education of study and clinic personnel.
  • Assists in planning, implementing, and evaluating program expansion and new projects.
  • Contributes positively and professionally to working groups and meetings.
  • Initiates and organizes meetings, prepares agendas, and discusses high-priority trials.
  • Presents protocols to programs and assesses 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 in developing initial and amended roadmaps.
  • Completes amended roadmaps by assigned dates to ensure patient safety.
  • Ensures roadmap submission forms are comprehensive and accurate, including all study assessments, 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

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

Pay

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

Schedule

• Scheduled weekly hours: 40