JOB DESCRIPTION: 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. 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.
WORK PERFORMED:
* 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 provides updates to study team members regarding protocol data management activities, including data entry timelines, database locks, unique study requirements, and query management. Also provides support, ongoing education and updates to study team members, physicians, nurses, and other healthcare professionals regarding data-related protocol activities.
* Provides onboarding, training, and quality assurance of CRDC I and II positions
* Attends protocol related training meetings and completes all required study training
* Liaises with sponsors and the in-house monitoring team, schedules monitoring visits, and addresses monitoring report findings.
* Leads the CRDC effort in preparing for and participating in quality control audits to verify the accuracy, completeness, and confidentiality of research data. Reports and addresses findings as appropriate.
* Establishes and maintains procedures and systems (i.e., computerized database) for research coordination and data management. Provides support to Winship¿s Informatics team as they develop and improve research information systems
* Assures ongoing compliance with all departmental, institutional, and federal requirements and regulations and department policies. Maintains controls to assure accuracy, completeness, and confidentiality of research data.
* Maintains confidentiality standards for all potential and enrolled patients; complies with federal Health Insurance * Orders and maintains equipment and supplies for research protocols and supports DC I and II as needed.
* Performs other duties as assigned.
MINIMUM QUALIFICATIONS: Bachelor's in a scientific, health related, or business administration program and three (3) years of clinical research data management experience or an equivalent combination of education and experience. Experience in electronic data capture (EDC) systems and clinical trials monitoring systems (CTMS) required.
PREFERRED QUALIFICATIONS: Working knowledge of ICH/GCP guidelines, clinical research, clinical trials process and FDA regulations preferred. ACRP/SoCRA (or equivalent) certification preferred within three (3) years of hire
Position intended to support clinical research and all clinical training requirements must be tracked and monitored through Emory Healthcare under the credentialing category of Clinical Researcher.
Certification/license |
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