Morrisville, NC30+ days ago
Reviews the project oversight dashboards and other clinical trial systems, such as Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS, IWS, Central Monitoring dashboards, to oversee site and patient activities, study team conduct, and to ensure the data has been updated to reflect timely execution of all operational aspects required visits, calls, duration, and frequency according to plan. Reviews the content and quality of site and central monitoring documentation, site monitoring calls, site visit reports, site letters, central monitoring reports, and pertinent correspondence to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol, GCP, compliance, trial conduct, patient safety, or data integrity.