Responsibilities

The CRA (Level I) will monitor investigator sites using a risk-based approach, applying root cause analysis, critical thinking, and problem-solving skills to identify site process failures and implement corrective and preventive actions to ensure compliance and reduce risks. They will ensure data accuracy through SDR, SDV, and CRF review, conduct physical inventory and records review, document observations in reports, escalate deficiencies to clinical management, maintain contact with sites, participate in investigator meetings, initiate clinical trial sites, perform trial close out, conduct on-site file reviews, provide trial status updates, ensure study systems are complete, facilitate communication between teams, and respond to company and regulatory inquiries.