The CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs. * Perform feasibility, site identification, selection and evaluation, supporting initial list of sites and recruitment targets * Provides protocol and related study training to assigned sites. * Manages sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution. * Establish regular lines of communication with sites and reports site progress, issues and proposed action to Clinical Operations * Ensure inspection readiness of the study and sites * Collaborates with Regional and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)
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