• 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