Senior Compliance Specialist
Senior Compliance Specialist
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 Functions
- Oversee, 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 CTO
- Assist 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 required Nearly 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
Special Instructions
Requisition Number: PRN42278B
Full Time or Part Time? Full Time
Work Schedule Summary:
Department: 01345 - HCI Clinical Resrch Compliance
Location: Campus
Pay Rate Range: 47600 to 90400
Close Date: 8/4/2025
Open Until Filled:
To apply, visit https://utah.peopleadmin.com/postings/184442
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