The Clinical Site Auditor reviews HCI Investigator Initiated Trials (IITs) for accuracy, internal consistency, and compliance with applicable regulations, standard operating procedures (SOP) and GCP guidelines. The auditor is a member of the Research Compliance Office and conducts audits on oncology/hematology clinical trials with varying complexity and risk levels including phase I, first in man trials.
Audits of HCI IITs are performed independent of routine study monitoring and in general, are conducted to verify the effectiveness of routine monitoring. The Auditor will verify during each audit overall compliance to the study protocol including review of subject eligibility, informed consent, disease outcome, AEs and toxicity reporting. The Auditor will also ensure regulatory documentation and completeness of essential documents, investigational drug/pharmacy records, and data quality by auditing the electronic Case Report Forms. The Auditor reviews previous audit reports and monitoring letters to verify correction of issues/findings or to discover any recurring issues or negative trends that may exist. Additionally, the Auditor will work with the study teams to develop Corrective and Preventive Action Plans (CAPAs) when needed and ensure any findings are brought to resolution. Study subject records or research charts are audited to ensure the authenticity of study conduct and validity of study results and to ensure inspection readiness by regulatory authorities.
This position will work with external sites participating in our IITs by auditing all sites on a routine basis, obtaining access to their electronic platforms and working with external sites to ensure their internal processes are being done per SOP and study contracts. Audits are performed remotely, however travel to the sites may be required.
This job has the ability to be a hybrid schedule of remote and in office work.
Huntsman Cancer Institute is committed to cancer prevention, care, and survivorship for all communities within the area we serve – which includes Idaho, Montana, Nevada, Utah, and Wyoming – with impact worldwide.
In your cover letter or during your interview process, we invite you to share how your professional experiences have prepared you to serve as a member of our team as we work to reduce the cancer burden experienced by all people and communities. This may include description of your prior experiences related to research, prevention, clinical care, community engagement/outreach, training, administration, or other areas relevant to Huntsman Cancer Institute’s mission and this position.
