UNIV - Data Core Coordinator - Hollings Cancer Center

Medical University of South Carolina•Charleston, SC

2d•Onsite

About The Position

Hollings Cancer Center (HCC) is recruiting for a Data Core Program Manager for the HCC Clinical Trials Office (CTO). 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 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.

Requirements

A bachelor's degree and two years of relevant program experience.

Nice To Haves

Prior clinical research experience, especially within oncology, is preferred.

Responsibilities

Responsible for monitoring all data submitted to the NCI databases and CTSU OPEN by CTO staff at baseline, on-treatment, and follow-up time points, focusing on Good Clinical Practice (GCP), CTO SOPs, and best practices for national studies.
Completes monitoring reports in the CTMS (OnCore) in a timely manner and shares findings with the Data Core Program Manager, Study or Data Coordinator who completed data entry, and the assigned Clinical Operations Program Managers.
Provides retraining to staff on deficiencies identified and escalates concerns regarding staff performance to the Data Core Program Manager, Associate Directors of Clinical Operations, and Clinical Operations Program Managers.
Submit accurate and timely data to research databases (NCI, industry sponsors, MUSC) for assigned patient caseloads across multiple disease programs and protocols.
Manage subject research charts, case report forms (CRFs), and source documentation per clinical trial standards.
Interpret protocols and informed consents to develop study-related forms, calendars, and documents.
Perform chart abstraction, data retrieval, and maintain comprehensive patient records, including quality-of-life (QOL) surveys, radiologic scans, and staging tests.
Ensure compliance with sponsor timelines for data submission, query resolution, adverse event (AE) and concomitant medication logs.
Report AEs and Serious AEs to NCI, sponsors, IRB, and DSMC per federal and institutional guidelines; maintain tracking logs and meet reporting deadlines.
Handle protocol deviations, screening logs, and database updates within required timeframes.
Obtain IROC radiologic credentialing; transmit required scans/EKGs and resolve vendor queries in collaboration with MUSC Radiology.
Participate in staff training on NCI CTCAE reporting and maintain proficiency in oncology adverse event terminology.
Meticulous data management is required for assigned studies and patient caseloads.
In collaboration with the Data Core Manager, this position will support the identification and implementation of new initiatives 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 monitoring visits.
Will work closely with the Data Core Manager and the Quality Assurance and Education Unit to onboard new Clinical Operations staff and develop data management skills.
Will review data management performance metrics and propose new initiatives to leadership.
Receive and prepare biospecimens for analysis by performing various processing techniques (centrifugation, aliquoting, etc.) according to protocol processing requirements.
Collaborate with CTO staff to coordinate biospecimen-related activities.
Operate and maintain laboratory equipment used in biospecimen processing.
Prepare, transport, and handle bloodborne pathogens and other biologic specimens following OSHA and IATA guidelines.
Ensure pathology specimens are collected and submitted to study sponsors at designated protocol time points.
Communicate effectively to report any deviations or issues in processing protocols.