Job Details

Clinical Site Monitor

Position Number: 7134953
Location: Salt Lake City, UT
Position Type: Laboratory and Research

Clinical Site Monitor

Job Summary

The Clinical Site Auditor reviews HCI Investigator Initiated Trials (IITs) for accuracy, internal consistency, and compliance with applicable regulations, standard operating procedures (SOP) and GCP guidelines. The auditor is a member of the Research Compliance Office and conducts audits on oncology/hematology clinical trials with varying complexity and risk levels including phase I, first in man trials.

Audits of HCI IITs are performed independent of routine study monitoring and in general, are conducted to verify the effectiveness of routine monitoring. The Auditor will verify during each audit overall compliance to the study protocol including review of subject eligibility, informed consent, disease outcome, AEs and toxicity reporting. The Auditor will also ensure regulatory documentation and completeness of essential documents, investigational drug/pharmacy records, and data quality by auditing the electronic Case Report Forms. 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. Additionally, the Auditor will work with the study teams to develop Corrective and Preventive Action Plans (CAPAs) when needed and ensure any findings are brought to resolution. Study subject records or research charts are audited to ensure the authenticity of study conduct and validity of study results and to ensure inspection readiness by regulatory authorities.

This position will work with external sites participating in our IITs by auditing all sites on a routine basis, obtaining access to their electronic platforms and working with external sites to ensure their internal processes are being done per SOP and study contracts. Audits are performed remotely, however travel to the sites may be required.

This job has the ability to be a hybrid schedule of remote and in office work.

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

Oversee, coordinate and conduct routine audits on cancer related investigator-initiated clinical trials at Huntsman Cancer Institute, as well as other external participating cancer centers, 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.
Analyze and document audit process, results, and outcome. Report outcomes to the DSMC.
Determine the validity of collected data, conduct periodic data audits, assessing process shortfalls, and developing effective safeguards to reduce risk in clinical research.
Recommend corrections to audit findings, assist teams in the development of CAPAs and other 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.
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).
Conduct routine audits at HCI and external participating sites and work with the sites to ensure study compliance.
Project manage assigned clinical trials by facilitating study team questions, study registrations, training on the protocol and acting as a liaison to the Data and Safety Monitoring Committee.
Provide project management support for low risk investigator-initiated trials including patient registrations.

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

Minimum Qualifications
Bachelor's degree in a health science or related field or equivalency (one year of education can be substituted for two years of related work experience); and four years of clinical research experience that includes regulatory compliance monitoring/auditing, IRB application submission, and experience in human subjects research. Must have a working knowledge of FDA, ICH, and other regulatory compliance; an understanding of medical terminology and technical writing experience. Excellent interpersonal communication (including oral and written) and leadership skills also required. Must be proficient in Microsoft Office and possess the ability to learn new software programs.

This position is patient-sensitive and must fulfill all associated requirements. We protect our patients, coworkers and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations.

Preferences include credentialing as a Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), and/or Certified Clinical Research Professional (CCRP). Prior experience as an industry CRA or Monitor is also preferred.

Hiring department may require certification by an appropriate certifying body within two years of hire.

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

Preferences

Prior experience working in cancer related research. Knowledge of oncology/hematology with strong understanding of medical terminology.
An understanding of University operations, policies and technology is preferred.

Special Instructions

Requisition Number: PRN44938B
Full Time or Part Time? Full Time
Work Schedule Summary:
Department: 01345 - HCI Clinical Resrch Compliance
Location: Campus
Pay Rate Range: 47600 to 75000
Close Date: 8/15/2026
Open Until Filled:

To apply, visit https://utah.peopleadmin.com/postings/201468