JOB DESCRIPTION : The Clinical Research Data Coordinator I supports the research program within the Clinical Trials Office (CTO) of Winship Cancer Institute (WCI) at Emory University. The Data Coordinator I, primarily serves in a supportive role coordinating and maintaining data activities related to clinical trials. This role collaborates with the clinical, informatics, quality monitors, and/or regulatory teams to document and report study patient enrollment, treatment, and follow-up information into databases as specified by research protocols.
WORK PERFORMED:
* Supports and assists in all aspects of clinical data management, protocol data management, including creation and collection of source documents, completion of case report forms, and tracking and reporting of serious adverse events.
* Primary Data Coordinator (DC) for therapeutic and non-therapeutic clinical trials across all disease teams, including complex areas such as hematologic cancers, Bone Marrow Transplant (BMT), Phase I trials, etc. More experienced Data Coordinators will be assigned to multi-center trials and Winship-held Investigator-Initiated Trials (IITs).
* Reviews 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.
* Accurately captures and enters data into clinical trial databases as necessary, and within timelines set by study sponsors or CTO. Collects and maintains complete records and metrics on each research study participant. Consolidates clinical data and reports for investigators as needed.
* 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 data query management.
* Attends protocol related training meetings and completes all required study training.
* Prepares for and assists with internal quality control audits to verify the accuracy, completeness, and confidentiality of research data. Reports and addresses findings as appropriate.
* Provides support during internal and external monitoring and auditing (e.g., sponsor, regulatory agencies) preparation, including supporting data deficiency corrections and development of corrective action plans post audit.
* Assists in the establishment and maintenance of procedures and systems (i.e., computerized database) for research coordination and data management.
* Assures ongoing compliance with all departmental, institutional, and federal requirements and regulations. Maintains controls to assure accuracy, completeness, and confidentiality of research data.
* Maintains confidentiality standards for all potential and enrolled study participants; complies with federal Health Insurance Portability and Accountability Act (HIPAA) regulations.
* Performs other duties as requested.
MINIMUM QUALIFICATIONS: (1.) High School Diploma or GED and three years of administrative support experience
OR
(2.) Two years of college in a scientific, health related, or business administration program and one year of admin support or customer service experience
OR
(3.) Licensed as a practical nurse (LPN) and one year admin support or one year of licensed practical nursing experience
OR
(4.) Bachelor's degree, Master's degree, MD or PhD in a scientific, health related or business administration program.
This position is 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. |
Emory University is dedicated to providing equal opportunities to all individuals regardless of race, color, religion, ethnic or national origin, gender, age, disability, sexual orientation, gender identity, gender expression, veteran's status, or any other factor that is a prohibited consideration under applicable law. |
Human Resources