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Job Title

The Clinical Trial Monitor is accountable for verifying compliance of investigator sites with regulatory and ICH GCP obligations, ensuring adherence to best practices.

  • Evaluates site processes through risk-based monitoring, employing root cause analysis to identify failures and determine corrective actions.
  • Safeguards data integrity via source document review, on-site monitoring activities, and remote verification.
  • Examines investigational products by conducting physical inventory checks and reviewing records.
  • Drafts observations in reports and letters, adhering to accepted business writing standards.
  • Raises concerns and issues to clinical management, following up on resolution progress.