UNIV-Research Study Coordinator Hollings Cancer Center

$38,985 - $72,134/Yr

MUSC (Med. Univ of South Carolina) - Charleston, SC

Full-time

Charleston, SC

Religious, Grantmaking, Civic, Professional, and Similar Organizations

About the position

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 cooperative group and industry sponsored trials at the Medical University of South Carolina (MUSC). Actively promotes and increases awareness of the clinical trial program within HCC, exercises judgment regarding proper patient management, timely and accurately meets established reporting systems to research bases, National Cancer Institute, and MUSC staff.

Responsibilities

• Assists Physician Investigators to identify, consent, screen, register/enroll eligible patients to studies at Hollings Cancer Center and coordinates patient research related activities to accurately meet protocol requirements.
• Screens all patients at the Hollings Cancer Center that have been newly diagnosed, have progressed, or experienced a recurrence for possible inclusion into an active clinical trial.
• Informs potential patients on study specifics, coordinates initial protocol procedures/treatment plan and ensures required follow up procedures.
• Ensures protocol compliance for study patients.
• Ensures database updates to reflect accurate patient status.
• Utilizes office tools including Sharepoint, Clinical Data Center (CDC), and CTMS.
• Attends and actively participates in regularly scheduled multidisciplinary tumor boards, clinics, conferences, and any other forum where patients may be discussed.
• Documents that all new patients to Hollings Cancer Center, including newly diagnosed patients and patients with progression or new disease are screened for trial eligibility.
• Ensures no ineligible patients are registered.
• Provides protocol specific information for physicians, primary nurses, and patients.
• Participates in informed consent process by explaining protocol specific information to the patient/family and facilitating consent document process.
• Coordinates the clinical work-up to determine patient eligibility.
• Coordinates treatment plan and required follow-up with patient, medical staff, nursing staff and ancillary hospital personnel.
• Ensures that follow-up requirements per protocol are carried out in order to assess for response to treatment.
• Works closely with clinical nurse staff to coordinate patient care to meet protocol standards.
• Consults with the investigator to assess patient 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 both current and new patient information into the clinical trials database.
• 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 and queries by establishing effective daily routines and processes.
• Develops and implements an effective daily routine which minimally includes retrieval of ongoing data from local or outside source documents, completion of appropriate case report forms and any protocol-related query received.
• Ensures data is submitted according to sponsor mandated time frames and in a manner that affords maximum accuracy.
• Ensures source documentation is present in patient chart for case report form completion.
• Visit-specific CRFs are to be completed per sponsor requirements.
• Proactively plan, prioritize and manage responsibilities to ensure timely and accurate data submission to specified research bases.
• Timely and accurately submits Serious Adverse Events to sponsor, IRB and DSMC per institutional policies.
• Prepares and submits CTO-required and sponsor specific initial and follow up reports.
• Adheres to the reporting requirements within the Clinical Trials Office, MUSC and various study sponsors.
• Participates in Trial Start up process for new studies.
• Attends and actively participates in Disease Specific Focus Group Meetings.

Requirements

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

Benefits

• Hourly pay rate
• Scheduled weekly hours: 40
• Pay range: 38,985.00 - 55,559.50 - 72,134.00