UNIV-Research Data Coordinator Lead

Job Description Summary

Under general supervision of and collaboration with the Data Core Program Manager, the Data Coordinator Lead position will mentor other data managers and coordinators that will oversee patient data for patients enrolled to clinical trials managed by the HCC CTO. The types of data include follow-up patient data and as needed some more complex on-study patient data. Data management activities involve NCI Cooperative group, Investigator Initiated and Industry sponsored oncology trials and professional judgment is required regarding patient management and research protocol compliance.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type​

Classified

Cost Center

CC001332 HCC CTO Administration

Pay Rate Type

Salary

Pay Grade

University-06

Pay Range

46,655.00 - 66,488.00 - 86,321.000

Scheduled Weekly Hours

40

Work Shift

Job Description

35% - Unit Development and Strategic Planning- In collaboration with the Data Core Manager, this position will support the identification and implementation of new initiative to streamline and increase efficiencies of data management activities. This position will help develop strategic plans for the creation of a centralized data management core within the CTO. This may involve the creation and maintenance of new training and process guides for data management and implementation of corrective action plans related to data underperformance or deficiencies. Participates in staff training and new employee orientation and education regarding data management. Works effectively and cooperatively with colleagues, assists with audits and routine monitor visits. Will work closely with the Data Core Manager and Quality Assurance and Education unit to onboard new clinical operations staff to develop data management skills. Will review data management performance metrics and proposed new initiatives to leadership

30%- Data Management Support 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 group, Investigator Initiated and industry sponsored oncology trials at the Medical University of South Carolina (MUSC). Interprets protocols, informed consents and case report forms 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 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 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.   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.  Ensures source documentation is located within patient research chart for source documentation verification.   Visit-specific CRFs are to be completed per sponsor requirements.

25% - Prepares, transports, and handles blood borne pathogens and other biologic specimens following OSHA and IATA guidelines.  Collection and submission of pathology specimens and radiology images are submitted to study sponsor at designated time points per protocol. Responsible for laboratory supply kit management including storage and inventory. May support these activities for patients seen at HCC satellite locations in East Cooper and North Charleston.

Responsible for preparing kits for each patient 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, Nexus SCTR services, translational, fast flow and phlebotomy labs to facilitate protocol compliance.  Completes required specimen submission case repor