Clinical Trials Monitor/ Auditor
** This position can be remote **
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.
Key Responsibilities include:
· 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.
· May be required to travel to other participating sitesup to approximately 15% of the time to perform audits or monitoring of enrolled subjects as described above.
Basic education, experience and skills required for consideration:
· 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.
Preferred education experience and skills:
· Trained and certified as a Clinical Research Associate by the Association of Clinical Research Professionals (ACRP) or as a Clinical Research Professional by the Society of Clinical Research Associates (SoCRA).
· Oncology and /or hematology clinical trials
· Experience managing clinical trials.
· Experience as a regulatory affairs administrator.