• 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.