Clin Trials Monitor/ Auditor

aa067; United States; On-site; USD 60,000 - 90,000; Full time

Job summary

City of Hope seeks a Clinical Research Associate to join its auditing and monitoring team. You will audit investigator-initiated trials under COH IND/IDE, review regulatory documents, amendments, consents, and study data to ensure protocol compliance.

You will verify timely SAE reporting to regulators, confirm protocol deviations, generate audit and monitoring reports, and provide training to sponsors, principal investigators, CRCs, and clinical research nurses.

Qualifications

• Bachelor’s degree in biology, chemistry, biochemistry, physiology, nursing, or related fields.
• 2+ years of experience as an industry Clinical Research Associate, clinical trial auditor, or monitor.

Responsibilities

• Verify 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.
• Review the original protocol and all amendments, noting dates, changes in eligibility criteria, and any modifications in treatment procedures.
• Verify 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.

Education

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

Job description

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.

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.

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 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.

Your qualifications should include:

• 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.

City of Hope is an equal opportunity employer.