Clin Trials Monitor/ Auditor

City of Hope

1d•Onsite

About The Position

City of Hope is seeking a Clin Trials Monitor/Auditor to join their transformative team, dedicated to fighting cancer, diabetes, and other life-threatening illnesses. The role involves performing comprehensive audits and monitoring of City of Hope Investigator-initiated clinical trials conducted under a COH-sponsored IND or IDE, as well as other high-risk protocols. This includes reviewing internal regulatory documents, protocols, amendments, correspondence, and serious adverse event reports. The position requires performing extensive audits and monitoring visits to determine protocol compliance, specifically focusing on the consent process and eligibility criteria. The auditor will also conduct extensive reviews of case report forms and study data, utilizing medical records, laboratory data, transfusion services records, and any other source used to produce study data. A key responsibility is generating an audit report or monitoring report, summarizing the findings of all deviations, discrepancies, and incorrect or missing data.

Requirements

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 or monitor.

Responsibilities

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 or monitors 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 and monitoring 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.