Clinical Trials Monitor/Auditor

Posted 54ds ago

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Job Description

Clin Trials Monitor/Auditor conducting audits and monitoring City of Hope's clinical trials. Reviewing compliance, regulatory documents, and generating report findings for high-risk protocols.

Responsibilities:

  • Performs comprehensive audits and monitoring of City of Hope Investigator-initiated clinical trials conducted under a COH-sponsored IND or IDE and other high-risk protocols as necessary.
  • Reviews internal regulatory documents, protocols, amendments, correspondence and serious adverse event reports.
  • Performs extensive audits and monitoring visits to determine protocol compliance, including the consent process and eligibility criteria.
  • Performs extensive review of case report forms and study data, utilizing medical records, laboratory data, transfusion services records, and any other source used to produce study data.
  • Generates an audit report or monitoring report, summarizing the findings of all deviations, discrepancies, and incorrect or missing data.

Requirements:

  • Minimum Education: Bachelor’s degree in biology, chemistry, biochemistry, physiology, nursing, or other related fields.
  • Minimum Experience: Two or more years of experience as an industry Clinical Research Associate or clinical trial auditor or monitor.

Benefits:

  • Comprehensive Benefits