Senior Compliance Officer

Senior Compliance Officer

Open Date  | 06/24/2025
Requisition Number  | PRN42278B
Job Title  | Senior Compliance Officer
Working Title  | Senior Compliance Specialist
Job Grade  | F
FLSA Code  | Administrative
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  | 47600 to 90400
Close Date  | 08/04/2025
Priority Review Date (Note - Posting may close at any time) 

Job Summary 
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.

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  | 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.

Essential FunctionsOversee, coordinate and conduct routine audits on cancer related investigator-initiated clinical trials in accordance with the National Cancer Institute approved Data and Safety Monitoring Plan to ensure compliance with study protocol, University, state and federal guidelines. Compile comprehensive reports for Principal Investigators, the Data and Safety Monitoring Committee (DSMC) and other committees as assigned. Meet with PI and study team to discuss audit findings and resolutions. Analyze and document audit process, results, and outcome. Report outcomes to the DSMC. Determine the validity of collected data, assessing process shortfalls, and developing effective safeguards to reduce risk in clinical research. Recommend corrections to audit findings and enhancements to operating policies and procedures as well as study protocols. Develop departmental SOPs. Serve as the primary contact and expert regarding regulatory agency standards governing clinical trials. Conduct quality assurance reviews on non-IIT cancer related clinical trials to ensure compliance with study protocol, university, state, and federal guidelines. Develop, coordinate and participate in educational and training programs to enhance compliance and awareness of compliance issues. Assist with training and onboarding of new RCO staff. Act as a mentor to junior level staff. Assist manager to evaluate and prioritize workload within the team. Conduct training and continuing education events within the RCO and CTOAssist in addressing complicated questions within the team. May work with groups outside of the Clinical Trials Office, for example Population Sciences, to conduct audits to ensure compliance in their research Work with PI and study team to ensure compliance with the protocol, GCPs, applicable regulations and SOPs in order to protect the rights, safety and well-being of research participants and to protect the integrity of study data. Maintain current knowledge regarding federal and state guidance, including Good Clinical Practice (GCP).

Problem Solving
Incumbent is responsible for assisting the University in preparation for regulatory audits by developing, monitoring and updating quality controls and recommending actions to maintain compliance.

This position is the primary contact and expert regarding regulatory agency standards governing clinical trials. Representative challenges of this position include determining the validity of collected data, assessing process shortfalls, and developing effective safeguards to reduce risk.

The incumbent must possess the ability to foster collaborative working relationships with a wide range of constituencies as well as the RCO team.

Work Environment and Level of Frequency typically requiredNearly Continuously: Office environment.

Physical Requirements and Level of Frequency that may be requiredNearly Continuously: Sitting, hearing, listening, talking.Often: Repetitive hand motion (such as typing), walking.Seldom: Bending, reaching overhead.

Minimum Qualifications  | Bachelor’s Degree in Health Care Administration, Business Administration or a related field, or equivalency (one year of education can be substituted for two years of related work experience); plus seven years working experience, with at least four of those years in a compliance office or the equivalent; the American Health Information Management (AHIMA) or American Academy of Professional Coders (AAPC) recognized coding certification (CPC, CPC-H, ACS, CCS-P/H, RHIA); knowledge of medical auditing, Federal healthcare program policies and requirements (including Medicare Parts A and B), and ICD-10, CPT, HCPCS, DRG coding; proficient with word processing, spreadsheet and related computer applications; demonstrated human relations and effective communication skills also required.

Master’s Degree in a related field is preferred. Certification from the Healthcare Compliance Association (HCCA) as a Compliance Officer is preferred.
This position is not responsible for providing patient care.
Preferences  | A minimum of three years within the Research Compliance Office required unless outside experience is compatible and director/manager approved Displays attributes that go above and beyond required tasks and assignments Promote ideas for quality improvement for the department Autonomous, responsible and completes tasks timely Excellent communication skills An understanding of University operations, policies and technology is preferred. Training or teaching experience is also preferred 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.

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 University Human Resource Management 
 250 East 200 South, Suite 125 Salt Lake City, UT 84111
 Contact us: (801) 581-2169 By Email: employment@utah.edu