City of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases.

Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hope’s translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies and numerous breakthrough cancer drugs are based on technology developed at the institution. AccessHope™, a wholly owned subsidiary, was launched in 2019 and is dedicated to serving employers and their health care partners by providing access to City of Hope’s exceptional cancer expertise.

A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nation’s “Best Hospitals” in cancer by U.S. News & World Report and received Magnet Recognition from the American Nurses Credentialing Center. Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona.

Pay Rate: $38.11 - $59.07 per hour

About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 6,000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.

Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers that develops and institutes standards of care for cancer treatment.

Position Summary

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.

Your qualifications should include:

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.
Familiar with Investigational New Drug procedures, study protocols, the informed consent process, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and applicable regulatory requirements.

City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, please click here.

To learn more about our Comprehensive Benefits, please CLICK HERE.

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CLINICAL TRIALS MONITOR/ AUDITOR - 10026885