UNIV – RHN Lancaster Study Coordinator - Hollings Cancer Center

Responsibilities

• Coordinates patient research related activities to accurately meet protocol requirements and ensure protocol compliance for study participants.
• Ensures database updates to reflect accurate patient status; utilizes 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.
• Coordinates treatment plan and required follow-up with study participant, medical staff, nursing staff and ancillary hospital personnel.
• 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; 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 and EPIC within 24 hours of enrollment or status change.
• Assists investigators to identify, consent, screen, register/enroll eligible patients to oncology studies at MUSC Lancaster on behalf of Hollings Cancer Center.
• Screens all patients at MUSC Lancaster being screened for cancer, newly diagnosed, 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 other forums where patients may be discussed.
• Documents and tracks all screening efforts per departmental guidelines and establishes communication with physician investigators and care team regarding potential study participants.
• Participates in and supports the informed consent process per departmental and institutional policy.
• 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 including retrieval of ongoing data from local or outside medical records, completion of case report forms and any data query received.
• Ensures source documentation is present in patient chart for case report form completion; visit-specific CRFs are completed per sponsor requirements.
• Collaborates with Data Coordinators as needed with patient protocol visits including adverse event logs, patient questionnaires, picking up specimens, and transporting study supplies.
• 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.
• Submits regulatory documents upon receipt to the Manager of Regulatory Compliance including Adverse Event reports, protocol deviation reporting, protocol amendments, and sponsor correspondence.
• Addresses and closes items outstanding per sponsor monitoring visit letters within 4 weeks of receiving the monitoring letter or by the date of the monitor's next site visit, whichever is earlier.
• Maintains working knowledge of region-specific trial portfolio and participates in disease focus group meetings to support trial start up process for new studies and maintenance of protocol amendments.
• Presents pertinent research related data to the research focus group and individual investigators.
• Maintains up to date protocol information, communication and education of study and clinic personnel.
• Assists in planning, implementing, and evaluation of program expansion and new projects.
• Initiates and organizes meetings and prepares meeting agendas; discusses high-priority trials.
• Presents protocols to programs and clearly assesses patient population and feasibility of trial.
• Reviews new protocols during the In Approval Process-Step 1, completes the initial roadmap submission by designated timeline and obtains study specific credentialing per protocol requirements.
• Collaborates with the CTO nurse managers in development of initial roadmap and amended roadmaps as applicable.
• Completes the Initial roadmap submission by assigned due date with comprehensive and accurate forms including treatment arms, hold and call parameters and dosing modifications per protocol guidelines.

Minimum Requirements

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