UNIV-Research Data Coordinator-Hollings Cancer Center

Job Description Summary

Under general supervision of the Clinical Trials Office (CTO), Manager of Clinical Operations coordinates complex data management activities involving NCI Cooperative group, Investigator Initiated and industry sponsored oncology 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

CC001332 HCC CTO Administration

Pay Rate Type

Hourly

Pay Grade

University-GEN08

Pay Range

45,300.00 - 61,100.00 - 77,000.000

Scheduled Weekly Hours

40

Work Shift

Job Description

Summary:

Provides core support for protocol management, patient and data management for oncology research studies conducted at the Hollings Cancer Center. Professional judgment is required regarding patient management and research protocol compliance.​

Responsibilities:

35% - Timely and accurately submits data to established research bases including the National Cancer Institute, industry sponsors and MUSC. Maintains subject research charts and submits data for assigned patient caseload. Patient management will include multiple disease programs and protocols. Protocol management will include NCI cooperative groups, investigator initiated and industry sponsored oncology trials at the MUSC. Interprets protocols, informed consents and case report forms in order to develop and use study related forms, data, calendars and documents according to accepted clinical trials professional standards. Meticulous data management is required for assigned studies and patient caseload. Chart extraction, retrieval of outside medical records, admission records, clinic visits, and all source is required. Maintenance of research subject records and case report forms is essential. Case report submission may include patient reported outcome questionnaires, 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, study participant calendar, and source documents. Ensures data is submitted according to sponsor mandated time frames and in a manner that affords maximum accuracy. Data submission will include query resolution, and adverse event and concomitant medication logs. Maintains established workflows to identify data needs of numerous trials within multiple disease groups and communicates data entry needs to study team.

25% - Timely and accurately coordinates the process to request, prepare, ship and/or submit requirements per protocol and applicable study manuals. Submissions may include but are not limited to radiology images, EKGs, pathology specimens, blood borne pathogens and other biologic specimens. Prepares, transports, and handles blood borne pathogens and other biologic specimens in accordance with OSHA and IATA guidelines. Responsible for laboratory supply kit management including storage, inventory, and ordering to maintain lab kit supply. Lab kit management will require utilization of sponsor specific vendors along with internal lab kit and specimen management tracking systems and processes. Responsible for preparing kits for each study participant and ensuring collection and shipment per Federal guidelines. Prepares and ships frozen and ambient specimens, including central labs, pharmacokinetic and pharmacodynamics. Preparation includes professional communication and collaboration with colleagues, CTO Data Core, Nexus SCTR services, translational, fast flow and phlebotomy labs to facilitate protocol compliance. Completes required specimen submission case report forms, protocol specific shipping procedures and enters specimen tracking data on designated NCI and or sponsor vendor website including CTSU OPEN funding. Responsible for maintaining sponsor imaging portal access and transmitting radiology images per the protocol and sponsor requirements. Responsible for addressing queries issued by the sponsor and/or imaging vendor, including effective communication with the study team and MUSC radiology department as needed to resolve queries.

15% Coordinates trial follow up patient visits and related activities to accurately meet protocol requirements. Provides protocol specific information for study coordinators, physicians, nurses, and study participants. Coordinates required follow-up requirements with patient, medical staff, nursing staff and ancillary hospital personnel. Ensures that follow-up assessments are completed per protocol to meet study requirements. Works closely with clinical nurse staff to coordinate patient care to meet protoco