Clinical Trials Auditor REMOTE

Performs comprehensive audits 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 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 , summarizing the findings of all deviations, discrepancies, and incorrect or missing data.

As a successful candidate, you will:

• Verifies that required reporting of Serious Adverse Events (SAE) to all applicable regulatory agencies (FDA, OBA, RAC, NIH, NCI) has been completed in a timely manner.
• Reviews the original protocol and all amendments, noting dates, changes in eligibility criteria, and any modifications in treatment procedures.
• Verifies that required reporting of protocol deviations, unanticipated problems, and Serious Adverse Events (SAE) to internal organizations (IRB, CPRMC, IBC, OSBC, RSC, DSMC) has been completed in a timely manner.
• Audits study data, including the consent process, eligibility criteria and case report forms, utilizing medical records, laboratory data, transfusion services records, and any other source used to produce study data. Verifies that corrections to the CRFs are made correctly, if applicable.
• Generates audit reports , summarizing the findings of all protocol deviations,, discrepancies, and incorrect or missing data. When direction is needed, provides training for sponsors, principal investigators, CRCs, and clinical research nurses.

Your qualifications should include:

• Bachelor’s degree in biology, chemistry, biochemistry, physiology, nursing, or other related fields.

• Two or more years of experience as an industry Clinical Research Associate or clinical trial auditor .

City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, pleaseclick here.

To learn more about our Comprehensive Benefits, pleaseCLICK HERE.