[Hiring] Clin Trials Monitor/ Auditor @City of Hope
Role Description
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:
• 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.
• Audit or monitor 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.
• Verify that corrections to the CRFs are made correctly, if applicable.
• Generate audit reports and monitoring reports, summarizing the findings of all protocol deviations, discrepancies, and incorrect or missing data.
• Provide training for sponsors, principal investigators, CRCs, and clinical research nurses when direction is needed.
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.
Company 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.
Apply Now
Apply Now
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:
• 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.
• Audit or monitor 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.
• Verify that corrections to the CRFs are made correctly, if applicable.
• Generate audit reports and monitoring reports, summarizing the findings of all protocol deviations, discrepancies, and incorrect or missing data.
• Provide training for sponsors, principal investigators, CRCs, and clinical research nurses when direction is needed.
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.
Company 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.
Apply Now
Apply Now