UNIV -Research Data Coordinator - Hollings Cancer Center

Job Description Summary

This position coordinates protocol data management activities involving the National Cancer Institute (NCI), 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-04

Pay Range

33,339.00 - 47,509.00 - 61,680.000

Scheduled Weekly Hours

40

Work Shift

Job Description

Summary:

Under general supervision of the Clinical Trials Office (CTO) and specific disease group Program Manager within the Clinical Operations Unit, this position coordinates protocol data management activities involving the National Cancer Institute (NCI), investigator initiated and industry sponsored oncology trials at the Medical University of South Carolina (MUSC) including data entry into case report forms, specimen submissions, and patient follow-up visits.  Provides core support for oncology research studies at the Hollings Cancer Center. 

Responsibilities:

35% Maintains current, long-term follow-up and survival data on assigned patient caseload.   Data submission is timely and accurate per the protocol and patient calendar.    Patient management will include multiple disease programs and protocols.  Responsible for meticulous data management is required for assigned studies and patient caseload.  Chart abstraction, timely submission of data forms, retrieval of data (includes calling outside M.D.s and hospitals), 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 Quality of Life surveys, radiologic scans, reports and staging tests.   Proactively plan, prioritize and manage responsibilities to ensure timely and accurate data submission to specified research bases.  Ensures data is submitted according to sponsor mandated time frames and in a manner that affords maximum accuracy.  Data submission will include query resolution, adverse event logs, and concomitant medication logs.  Ensures source documentation is present in-patient chart for source documentation verification.

25% 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 protocol standards. Consults with the investigator to assess study participant for response to protocol therapy including toxicity assessment and disease status. Ensures timely clinical trial management system (CTMS) database updates to reflect accurate patient status within 24 hours. Links patient research visits in Epic prior to scheduled study visit date. Ensures source documentation is located within patient research chart for source documentation verification per departmental SOPs. 

20% 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 following 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 Nexus SCTR services, Fast Flow and phlebotomy lab to facilitate protocol compliance.  Completes required specimen submission case