Job Description
Clinical Trials Auditor REMOTE
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 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 , 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:
City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, pleaseclick here.
To learn more about our Comprehensive Benefits, pleaseCLICK HERE.
Salary / Pay Rate Information:
Pay Rate: $38.11 - $59.07 / hour
The estimated pay scale represents the typical [salary/hourly] range City of Hope reasonably expects to pay for this position, with offers determined based on several factors which may include, but not be limited to, the candidate’s experience, expertise, skills, education, job scope, training, internal equity, geography/market, etc. This pay scale is subject to change from time to time.
City of Hope is a community of people characterized by our diversity of thought, background and approach, but tied together by our commitment to care for and cure those with cancer and other life-threatening diseases. The innovation that our diversity produces in the areas of research, treatment, philanthropy and education has made us national leaders in this fight. Our unique and diverse workforce provides us the ability to understand our patients' needs, deliver compassionate care and continue the quest for a cure for life-threatening diseases. At City of Hope, diversity and inclusion is a core value at the heart of our mission. We strive to create an inclusive workplace environment that engages all of our employees and provides them with opportunities to develop and grow, both personally and professionally. Each day brings an opportunity to strengthen our work, leverage our different perspectives and improve our patients’ experiences by learning from others. Diversity and inclusion is about much more than policies and campaigns. It is an integral part of who we are as an institution, how we operate and how we see our future.
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