UNIV - Data Core Coordinator - Hollings Cancer Center

Job Description Summary Hollings Cancer Center (HCC) are 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. Entity Medical University of South Carolina (MUSC - Univ) Worker Type Employee Worker Sub-Type Research Grant Cost Center CC001332 HCC CTO Administration Pay Rate Type Salary Pay Grade University-GEN09 Pay Range 52,100.00 - 70,300.00 - 88,600.000 Scheduled Weekly Hours 40 Work Shift Job Description Hollings Cancer Center (HCC) are 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. Responsibilities: 35% – Secondary Data Reviews 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. When necessary, this position 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. 35% – Data Management Support 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. 20% – Unit Development and Strategic Planning 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. 10% – CTO Lab Support 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. Preferred experience and skills: Prior clinical research experience, especially within oncology, is preferred. Additional Job Description Minimum Requirements: A bachelor's degree and two years of relevant program experience. Physical Requirements: (Note: The following descriptions are applicable to this section: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift) Ability to perform job functions in an upright position. (Frequent) Ability to perform job functions in a seated position. (Frequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work outdoors in all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform job functions from kneeling positions. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to perform 'pinching' operations. (Infrequent) Ability to fully use both hands/arms. (Frequent) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to lift and carry 15 lbs., unassisted. (Infrequent) Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/40 vision, corrected, in one eye or with both eyes. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at a distance. (Frequent) Ability to determine distance/relationship between objects; depth perception. (Frequent) Good peripheral vision capabilities. (Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to perform gross motor functions with frequent fine motor movements. (Frequent) If you like working with energetic enthusiastic individuals, you will enjoy your career with us! The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need. Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: Thank you for wanting to be part of the Medical University of South Carolina team. Whether you want to teach the next generation of health care leaders, innovate new business models, discover the next breakthrough or provide patient care, there's a role for you that fuels your passion and takes advantage of your skills. There are career opportunities available in academics, research, hospital medicine, physician practices and support services, from patient billing to IT. As an applicant, you can search jobs for all MUSC entities as well as search by category and location. MUSC attracts more than $250 million annually in research funding, making it the biggest magnet for biomedical, extramural research dollars of all institutions of higher learning in South Carolina. The Clinical and Translational Science Award (CTSA) Program aims to advance clinical and translational science to increase the speed at which new treatments become available to patients. MUSC Health, the clinical enterprise, operates a 750 bed medical center, which includes a nationally recognized Children’s Hospital, the Ashley River Tower (cardiovascular, digestive disease, and surgical oncology), Hollings Cancer Center (one of fewer than 70 elite National Cancer Institute designated centers), a Level I Trauma Center and the Institute of Psychiatry. In addition, there are more than 100 outreach clinics, hospital/health system affiliations, and telehealth sites. U.S. News & World Report placed us among the top one percent of all American hospitals, with 11 specialties in the top 50. The MUSC Medical Center is also one of only three Magnet® designated hospitals in South Carolina.