Clinical Data Coordinator

• Enters study data into EMR and CTMS within 3 days of the study visit
• Build and maintain data standards for all clinical trials
• Participate in discussions related to and assist in the creation of Electron Data Capture (EDC) builds for Investigator Initiated Studies (IITs)
• Reviews and resolves queries within 3 days of notification
• Support clinical trial studies from preparation through closeout
• Ensure source documentation and management of clinical study data is in accordance with FDA regulations, ICH/GCP guidelines and ALCOCA + standards
• Perform quality assurance checks to ensure the accuracy of data entry
• Communicates with sponsors to address any protocol issues related to quality of data entry
• Escalates non-compliant data collection and/or submission
• Participates in departmental required meetings and trainings

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Senior Clinical Trials Data Coordinator