CLIN TRIALS MONITOR/ AUDITOR - 10033538

Anywhere, USA; Anywhere, USA

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: $39.25 - $60.84 per hour

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.

To learn more about our Comprehensive Benefits, pleaseCLICK HERE.