Clinical Trials Monitor/Auditor

Clinical Trials Monitor/Auditor at City of Hope

Join the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. Our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today.

The Clinical Trials Monitor/Auditor 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. This involves reviewing internal regulatory documents, protocols, amendments, correspondence, and serious adverse event reports. The role performs extensive audits and monitoring visits to determine protocol compliance, including the consent process and eligibility criteria. An extensive review of case report forms and study data is conducted, utilizing medical records, laboratory data, transfusion services records, and any other source used to produce study data. Finally, an audit or monitoring report is generated, summarizing findings of all deviations, discrepancies, and incorrect or missing data.

Key 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.

Qualifications

• 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.

City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location.

Key skills/competency

• Clinical Trial Monitoring
• Clinical Auditing
• GCP (Good Clinical Practice)
• FDA Regulations
• IND/IDE Compliance
• SAE Reporting
• Protocol Compliance
• Data Integrity
• Medical Record Review
• Regulatory Affairs