UNIV- Research Study Coordinator - Hollings Cancer Center

Overview

Job Description Summary The Clinical Trials Office (CTO) and specific disease group Program Manager within the Clinical Operations Unit are recruiting for a Research Coordinator.

Entity Medical University of South Carolina (MUSC - Univ)

Worker Type Employee

Worker Sub-Type Classified

Cost Center CC001332 HCC CTO Administration

Pay Rate Type Hourly

Pay Grade University-05

Pay Range 39,764.

- 73,576.000

Scheduled Weekly Hours 40

Work Shift

Summary

Job Description

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 ively promotes and increases awareness of the clinical trial program within HCC, exercises judgment regarding proper study participant management.

• 35% Coordinates patient research related activities to accurately meet protocol requirements.
• Ensure protocol compliance for study participants. Ensures database updates to reflect accurate 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 the 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.
  
  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 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 within specified parameters.
  
  Prepares, transports, and handles blood borne pathogens and other human specimens following OSHA guidelines. Enters and maintains both current and new study participant information into the clinical trials database. New patient enrollments and status updates are to be entered into the CTMS within 24 hours of the enrollment or status change. This includes Screening, Screen Failures, Consenting, Enrolling, Active on Treatment, Follow up, and Off study status.
  
  New patient enrollments and status updates are to be entered/confirmed in EPIC within 24 hours of the enrollment and or status change. This includes Consented- in screening, Enrolled-Receiving treatment and/or intervention, Enrolled-follow up only, lost to follow up, Screen failure and completed. Research participant protocol-related visits must be linked in EPIC prior to the encounter.
• 20% Assists investigators to identify, consent, screen, register/ enroll eligible patients to studies at Hollings Cancer Center. Screens all patients at the Hollings Cancer Center (HCC) that have been newly diagnosed, have 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 any other forum where patients may be discussed.
  
  Documents and tracks all screening efforts per departmental guidelines. Establishes communication with physician investigators and care team regarding potential study participants. Effective screening of HCC patient medical records requires knowledge of oncology terminology, medical terminology, disease specific staging and each clinical trial protocol eligibility criterion. Meets weekly with their clinical operations team to discuss potential trial participants and plan for the upcoming week for all clinic coverage needs.
  
  Under guidance of the team lead coordinator(s) and program manager, will support research activities at any of the MUSC main campus and HCC satellite locations and make necessary coverage plans in advance, to avoid interruption of quality CTO services. Participates in and supports the informed consent process per departmental and institutional policy.
• 20% 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 which minimally includes retrieval of ongoing data from local or outside medical records, completion of appropriate case report forms and any data 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.…