Business Data Analyst Sr

Job Summary
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.

Responsibilities
Essential Functions Collaborate with crossfunctional teams to integrate Part 11 Compliance requirements into business processes and systems. Develop policies and standard operating procedures outlining the requirements to validate and maintain Part 11 compliance for applicable business systems. Analyze and document Part 11 Compliance processes and assessments when new upgrades and changes are made within the business systems. Provide periodic audits of our business systems and assessment to ensure ongoing compliance. Manage and oversee the InvestigatorInitiated Data Management team within the HCI Research Compliance Office. Create standard electronic case report forms (eCRFs) and a process for our Clinical Trial electronic data capture system compliance with FDA Data Submission Standards. Facilitate and coordinate with cross functional teams to develop customized reports for committees at HCI . Compile comprehensive reports for Principal Investigators the Data Safety Monitoring Committee and other committees as assigned. Develop monitor and update study specific case report forms and progress of the electronic data capture for Investigator Initiated Trials. Assist with training and onboarding of new RCO staff. Attend meetings with study teams to facilitate compliance questions and oversight. Develop and recommend enhancements for process improvements. Evaluate and prioritize workload within the RCO Data Management team. Assist in addressing complicated questions within the team. Develop coordinate and participate in educational and training programs to enhance compliance and awareness of compliance issues. Maintain current knowledge regarding federal and state guidance including Good Clinical Practice GCP . This position is not responsible for providing patient care. Disclaimer This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties responsibilities and qualifications required of employees assigned to the job Comments Familiar with a variety of the fields concepts practices and procedures. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. May lead and direct the work of others. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department. Work Environment and Level of Frequency typically required Nearly Continuously: Office environment. Physical Requirements and Level of Frequency that may be required Nearly Continuously: Sitting hearing listening talking. Often: Repetitive hand motion (such as typing) walking. Seldom: Bending reaching overhead.

Minimum Qualifications
Requires a bachelors degree in area of specialty or equivalency (one year of education can be substituted for two years of related work experience). Four to six years of experience in the field or in a related area required. Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.