Senior Compliance Officer
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About The Position
The Clinical Site Auditor reviews HCI Investigator Initiated Trials (IITs) for accuracy, internal consistency, and compliance with applicable regulations and GCP guidelines. The auditor is a member of the Research Compliance Office (RCO) and conducts an initial audit approximately one year after enrollment begins and annually thereafter for IITs of all risk levels. In general, audits are conducted to verify the effectiveness of monitoring, including review of subject eligibility, informed consent, disease outcome, AEs and toxicity, data quality, regulatory documentation, investigational drug records, and compliance with institutional procedures and applicable regulations and guidelines. 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. Study subject records or research charts are audited to ensure the authenticity of study conduct and validity of study results. Audits of HCI IITs are performed independent of study monitoring. Certified Clinical Research Professional (CCRP, CCRC or CCRA) and prior experience or knowledge of oncology, and oncology related research is essential. The individual should have proven leadership and job performance with ability to manage increasingly complex tasks. The Senior Auditor will perform those functions of Clinical Site Auditor and will act as a mentor to junior RCO staff. The Senior Auditor will assist the manager in evaluating workload, creating and implementing process improvements and other training needs within the department and institution.
