Emory Healthcare/Emory University Clinical Research Coordinator, Quality Mgmt in Atlanta, Georgia
The Clinical Research Coordinator, Quality Management (CRCQM) develops, implements, and oversees quality management for clinical trials. Performs real time, day-to-day, observation and documentation of trial work processes; Conducts quality assurance reviews of source documents to ensure adherence to policies and procedures, study protocols, and research record accuracy; Conducts quality control reviews of 100% of case report forms (CRFs), electronic CRFs and Source Documents (SDs) for accuracy and completeness.
The CRCQM develops Query requests for study staff, identifies trends or issues of concern and monitors corrections for timeliness and accuracy. The CRCQM reviews monitoring reports from external monitoring groups, develops corrective action plans, and works closely with study coordinators. Conducts regulatory file review at the beginning of a study and immediately prior to study termination. Responsible for ensuring that the conduct of a clinical trial meets the requirements established by Emory University, the International Conference on Harmonization (ICH) Guidelines for Good Clinical Practice (GCP) and the Federal Code of Regulations for Clinical Trials. Performs related approved responsibilities as required.
MINIMUM QUALIFICATIONS: Bachelor's degree in a scientific, health or business related program and three years clinical research experience or an equivalent combination of experience with three years of experience directly related to clinical research. NOTE: degree cannot be substituted for any portion of the required three years of clinical research experience. Certified Research Administrator (CRA) or Clinical Research Coordinator (CRC) preferred.
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.
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Job Number 42123
Job Type Regular Full-Time
Division Exec.V.P. for Health Affairs
Department Winship Clinical Trials
This position may involve the following Health and Safety issues: Not Applicable
Job Category Research & Research Administration
Location : Name Emory Campus-Clifton Corridor
Emory Healthcare/Emory University
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