Details **Open Date** 02/13/2025 **Requisition Number** PRN41183B **Job Title** Business Data Analyst Sr **Working Title** Sr. Business Data Analyst **Job Grade** G **FLSA Code** Computer Employee **Patient Sensitive Job Code?** No **Standard Hours per Week** 40 **Full Time or Part Time?** Full Time **Shift** Day **Work Schedule Summary** **VP Area** President **Department** 01345 - HCI Clinical Resrch Compliance **Location** Campus **City** Salt Lake City, UT **Type of Recruitment** External Posting **Pay Rate Range** 60700 to 90000 **Close Date** 05/12/2025 **Priority Review Date (Note - Posting may close at any time)** **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 we’ve 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 HCI’s 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 Institute’s mission and this position._ **Responsibilities** **Essential Functions** + Collaborate with cross-functional 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 Investigator-Initiated 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 field’s 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 bachelor’s 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. **Preferences** + A minimum of three years working in the Research Compliance field of work unless alternative experience is compatible and director/manager approved + Minimum of 3-5 years of experience in computerized systems validation and regulatory compliance. + Certification in the society of clinical research associates ( SOCRA ) or equivalent + In-depth knowledge of 21 CFR Part 11 and related regulations. + An understanding of University operations, policies and technology is preferred. + Autonomous, responsible and completes tasks timely + Excellent communication skills + Ability to foster teamwork **Type** Benefited Staff **Special Instructions Summary** **Additional Information** The University is a participating employer with Utah Retirement Systems (“URS”). Eligible new hires with prior URS service, may elect to enroll in URS if they make the election before they become eligible for retirement (usually the first day of work). Contact Human Resources at (801) 581-7447 for information. Individuals who previously retired and are receiving monthly retirement benefits from URS are subject to URS’ post-retirement rules and restrictions. Please contact Utah Retirement Systems at (801) 366-7770 or (800) 695-4877 or University Human Resource Management at (801) 581-7447 if you have questions regarding the post-retirement rules. This position may require the successful completion of a criminal background check and/or drug screen. The University of Utah values candidates who have experience working in settings with students and patients from all backgrounds and possess a strong commitment to improving access to higher education and quality healthcare for historically underrepresented students and patients. All qualified individuals are strongly encouraged to apply. Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities. The University of Utah is an Affirmative Action/Equal Opportunity employer and does not discriminate based upon race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender, gender identity, gender expression, pregnancy, pregnancy-related conditions, genetic information, or protected veteran’s status. The University does not discriminate on the basis of sex in the education program or activity that it operates, as required by Title IX and 34 CFR part 106. The requirement not to discriminate in education programs or activities extends to admission and employment. Inquiries about the application of Title IX and its regulations may be referred to the Title IX Coordinator, to the Department of Education, Office for Civil Rights, or both. To request a reasonable accommodation for a disability or if you or someone you know has experienced discrimination or sexual misconduct including sexual harassment, you may contact the Director/Title IX Coordinator in the Office of Equal Opportunity and Affirmative Action ( OEO /AA). More information, including the Director/Title IX Coordinator’s office address, electronic mail address, and telephone number can be located at: https://www.utah.edu/nondiscrimination/ Online reports may be submitted at oeo.utah.edu https://safety.utah.edu/safetyreport This report includes statistics about criminal offenses, hate crimes, arrests and referrals for disciplinary action, and Violence Against Women Act offenses. They also provide information about safety and security-related services offered by the University of Utah. A paper copy can be obtained by request at the Department of Public Safety located at 1658 East 500 South.