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Description
About Winship Cancer Institute of Emory University
Dedicated to discovering cures for cancer and inspiring hope, Winship Cancer Institute of Emory University is Georgia’s only National Cancer Institute-designated Comprehensive Cancer Center, a prestigious distinction given to the top tier of cancer centers nationwide for making breakthroughs against cancer. Winship is researching, developing, teaching, and providing novel and highly effective ways to prevent, detect, diagnose, treat, and survive cancer. Cancer care at Winship includes leading cancer specialists collaborating across disciplines to tailor treatment plans to each patient’s needs and type of cancer; innovative therapies and clinical trials; comprehensive patient and family support services; and a personalized care experience aimed at easing the burden of cancer. Winship is Where Science Becomes Hope®. For more information, visit winshipcancer.emory.edu.
Winship is seeking qualified candidates for the Supervisor, Clinical Research Data Team position. Position details are as follows:
The Supervisor, Clinical Research Data Team (SCRDT) supports the research program within the Clinical Trials Office (CTO) of Winship Cancer Institute (WCI) at Emory University. The SCRDT is responsible for overseeing the data activity of complex research trials. This role collaborates with the clinical and regulatory teams to document and report study patient enrollment, treatment, and follow-up information into databases as specified by research protocols.
KEY RESPONSIBILITIES:
This position is responsible for the implementation and conduct of data management and compliance of multiple research projects and interacts closely with institutional investigators, study sponsors, and the study team.
The SCRDT is responsible for providing guidance and supporting training of DC I and DC II positions.
The SCRDT serves as a resource regarding clinical research and compliance for Investigators, Nurses, Pharmacists, Pathologists, Radiologists, and other Healthcare personnel involved in the care and management of patients at WCI.
Provide supervision and day-to-day oversight to the Data Coordinators Is and IIs .
Develop database clinical trial data specification and metrics, to decrease data delinquencies, missing documents, data accuracy query logic and data validation.
Responsible for double-data entry (DDE) and quality management of data entry for NCTN, IIT and sponsor clinical trials.
Create and maintain project Data Management documentations (Data Management Plan).
Extract and monitor clinical trial data to identify issues or trends reporting this information to Winship CTO Leadership.
Ensure clinical trials data within EDC, OnCore, EPIC, and sponsor CTMS is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and final database lock ¿ included but not limited to data reconciliation.
Manage data inspections and/or audits with clinical trials monitors, FDA inspectors, NCTN auditors, quality management, data safety and monitoring committee and Emory CTAC.
Ensures data system compliance by following the established guidelines of national regulatory authorities.
Independently responsible for all aspects of clinical data management including creation and collection of source documents, completion of case report forms, and tracking and reporting of serious adverse events.
Reviews and analyzes information from medical records (clinic notes, pathology reports, radiology reports, patient questionnaires, etc.) to extract data for all assigned research protocols including but not limited to industry, cooperative group, and investigator-initiated studies.
Attends study team meetings and…