Merakey Jobs

This position will be responsible for ensuring compliance with 21 CFR Part 11, referred to as Part 11 Compliance, at Huntsman Cancer Institute (HCI) and will report to the Research Compliance Office (RCO) Director. Part 11 Compliance is a regulation set by the FDA to ensure that institutions are handling clinical research related to electronic records and signatures in a manner that is as trustworthy and reliable as a paper record with a wet ink signature. This system maintenance includes validating ongoing updates by assessing the risk of those updates and ensuring there is no risk or change in how our electronic signatures are obtained and maintained within the system. This ongoing system validation requires appropriate documentation showing that weve tested those updates and determined whether there was a risk and validated the update prior to the update going live within the system. Additionally, there needs to be ongoing access controls to ensure only authorized personnel have access to the system and have been trained to use the system appropriately. Additionally, periodic audits are necessary to ensure that only authorized users have the capability to access or modify electronic records. The ideal candidate will have a strong background in computerized systems validation, regulatory compliance, and quality assurance within the clinical trial industry.This position will work closely with the HCI Clinical Trials Office (CTO), HCI-IT, and Research Informatics Shared Resource (RISR). This Business Data Analyst can be a bridge between the technical teams and the clinical researchers to translate complex data standard requirements into efficient clinical research databases for researchers. Overall, the Business Data Analyst will ensure that systems are compliant and functional and align with HCIs mission and strategic goals to advance medicine in cancer care research and delivery.Lastly, this position will be responsible for the personnel management of Research Data Managers who are regularly working in HCI electronic systems. As a Manager in the RCO, this individual will be expected to have proven leadership skills and job performance to manage increasingly complex tasks including developing and implementing process improvements within the Research Compliance Office. 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 Institutes mission and this position.