UNIV - Research Data Coordinator-Hollings Cancer Center

Summary:

Under general supervision of the Clinical Trials Office (CTO) and specific disease group Program Manager within the Clinical Operations Unit, this position coordinates complex data management activities involving the National Cancer Institute (NCI), investigator initiated and industry sponsored oncology trials at the Medical University of South Carolina (MUSC). Provides core support for protocol management, study participant and data management for oncology research studies conducted at the Hollings Cancer Center. Professional judgment is required regarding study participant 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 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. 

15% - Timely and accurately submits Adverse Events, Serious Adverse Events, and other reportable events to the NCI, sponsors, IRB and DSMC per federal guidelines and institutional policies. Proactively plans to ensure comprehensive reports are submitted per the Clinical Trials Office standard operating procedures, to ensure submission to the IRB of record and study sponsor is completed within the permitted timeframe. Reportable events requiring expedited submission may include adverse events, serious adverse events, correspondence from the sponsor, protocol deviations, or any other documents requiring review and submission to the IRB. Protocol deviations will be reported to the clinical trials office regulatory unit per departmental processes. Prepares and submits initial and follow up adverse events as required and until resolution of adverse events. Responsible for contemporaneous completion of adverse event logs. Coordinates the reporting of adverse events and serious adverse events based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) and protocol requirements. Adverse Event tracking is completed and maintained for numerous research subjects on various studies. Participates in staff training on NCI CTC adverse event reporting. This training may include Adverse Events, Serious Adverse Events, baseline medical history, and Adverse Event and concomitant medication tracking logs. Items that are outstanding per sponsor monitoring visit letters will be addressed and closed within 4 weeks of receiving the monitoring letter, or by the date of the monitor’s next site visit, whichever is earlier. 

10% - Attends and actively participates in staff training and education regarding data management and clinical operations processes. Trainings include but are not limited to CTO staff meetings, Clinical Operations Update Meetings, huddles and team meetings. Works effectively and cooperatively with colleagues to assist routine monitor visits. Utilizes office tools including sharepoint, clinical trial management system, Clinical Data Center (CDC), and other applicable platforms. Collaborates with Study Coordinators as needed with participant protocol visits including participant questionnaires, escorting study participants to various locations on campus, picking up IDS oral study medication, and transporting study supplies. Completes other research tasks and projects as assigned. Assists with the development of educational materials specific to each study and disseminates to appropriate staff. Staff training may include CTSU, NCI data bases, CTMS, SharePoint, EPIC EMR, EPIC patient linking of research participants, collection and shipping of specimens, requesting internal and external radiologic images and submitting to study sponsor.