UNIV - Research Study Coordinator - Hollings Cancer Center

UNIV - Research Study Coordinator - Hollings Cancer Center page is loaded## UNIV - Research Study Coordinator - Hollings Cancer Centerlocations : Charlestontime type : Full timeposted on : Posted Todayjob requisition id : R-0000048686 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 I. 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 enter (HCC) to efficiently and effectively integrate cooperative group and industry sponsored trials at the Medical University of South Carolina (MUSC). Entity Medical University of South Carolina (MUSC - Univ) Worker Type Employee Worker Sub-Type Classified Cost Center CC001333 HCC CTO Clinical Trials Pay Rate Type Hourly Pay Grade University-05 Pay Range 39,764.00 - 56,670.00 - 73,576.000 Scheduled Weekly Hours 40 Work Shift 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 I. 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 enter (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 : 35% Assist 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. Ensure 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. New patient enrollments and status updates are to be entered into the clinical trials database within 24 hours of the enrollment and or status change. This includes Screening, Screen Failures, Consenting, Enrolling, Active on Treatment, Follow up, Survival and Off study status. New patient enrollments and status updates are to be entered into 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 Patient Status changes and protocol-related patient visits be linked in EPIC prior to the protocol-related patient visit.30% 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. Case report submission may include QOL surveys, radiologic scans, reports and staging tests. Proactively plan, prioritize and manage responsibilities to ensure timely and accurate data submission to specified research bases. Data submission is timely and accurate per the protocol, patient calendar, and source documents. Collaborates with Data Coordinators as needed with patient protocol visits including adverse event logs, patient questionnaires, picking up specimens, and transporting study supplies.15% 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. Proactively plans to ensure reports are comprehensive and that reporting requirements are met within the allowable timeframe and in a manner that affords maximum accuracy. Submits regulatory documents upon receipt to the Manager of Regulatory Compliance to ensure timely reporting by the regulatory unit of CTO. This includes on-site Adverse Event reports and protocol deviation reporting as well as any new protocol documents which may include but are not limited to synopsis, confidentiality agreements, protocol, questionnaires, amendments, correspondence from sponsor, or any other documents requiring review and / or submission to IRB. Additional non-regulatory reporting requirements would include submission of screening logs and database updates. For any protocol deviations that are known, these will be reported to Regulatory within 7 business days of knowing of the deviation. Items that are outstanding per sponsor monitoring visit letters will be addressed and closed within 4 weeks of receiving the monitoring letter, or by the date of the monitor's next site visit, whichever is earlier.10% Participates in Trial Start up process for new studies. During the "In Approval Process-Step 1" reviews new protocols, completes the Initial Roadmap submission by designated timeline and obtains study specific credentialing per protocol requirements. As protocol amendments are

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