Clin Trials Monitor​/Auditor

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.

• 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. When direction is needed, provide training for sponsors, principal investigators, CRCs, and clinical research nurses.
• May be required to travel to other participating sites up to approximately 15% of the time to perform audits or monitoring of enrolled subjects as described above.

• 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 is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, please .

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