The Sr CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality. The Sr CRA works closely with US: Director of Clinical Monitoring, Lead CRAs, in-house CRAs, EU: Associate Director of Clinical Monitoring, CRAs, and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. * Provides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements. * For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor. * Works closely with in-house CRAs/CTC and data management to resolve queries on discrepant data.
mehr