CRA (Level II)

The CRA (Level II) is responsible for monitoring investigator sites using a risk-based approach, identifying process failures, and implementing corrective actions to ensure compliance. They will ensure data accuracy through various review methods, assess investigational products, and document observations in timely reports. The role involves communicating deficiencies to management, maintaining contact with sites, conducting monitoring tasks per the plan, and participating in investigator payments. Responsibilities also include resolving findings, providing trial status updates, updating study systems, performing QC checks, participating in investigator meetings, identifying potential investigators, initiating clinical trial sites, ensuring trial close-out, and managing essential documents. The CRA will also assist in project publications, perform assigned study tasks, facilitate communication between sites, clients, and the project team, respond to regulatory requirements, and complete administrative tasks. Additionally, they will contribute to process improvement initiatives.