Site Monitor Jobs (NOW HIRING)

This position will provide project management and clinical monitoring support for Investigator‑Initiated Trials (IITs) coordinated by the Huntsman Cancer Institute (HCI) Research Compliance Office (RCO) from trial start‑up through trial closeout. The incumbent will act as a liaison between clinical sites, the Research Compliance Office, sponsors/funding agencies and the Principal Investigators to ensure that clinical trials are conducted in compliance with the protocol, and applicable institutional and regulatory guidelines. As a member in the Research Compliance Office department, the candidate will also be responsible for quality assurance oversight of clinical trials via monitoring and auditing trials and reporting study progress to the Data Safety Monitoring Committee (DSMC). This is a hybrid position and requires onsite work to be performed at Huntsman Cancer Institute, where some of the work may be done remotely.

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.

1. Performs on‑site and remote monitoring activities of clinical research studies.
2. Oversee, coordinate and conduct monitoring of clinical investigations to ensure compliance with University, FDA, OHRP, Good Clinical Practice (GCP), state and federal guidelines.
3. Analyze and document monitoring processes for all activities in the conduct of the clinical investigation, and recommend improvements to operating policies and procedures for compliance review. Monitor and follow up on required documentation related to audit processes.
4. Develop and maintain site feasibility packets, multisite study procedural manuals, and other multisite process documents.
5. Prepare clinical sites for study start‑up by conducting site initiation visits.
6. Analyze and evaluate data gathered during research. Identify data discrepancies and missing data in source records or CRF’s.
7. Recognize protocol deviations and other study related issues and work to resolve and/or make appropriate recommendations for correction and full resolution.
8. Perform dual review of eligibility to verify that potential clinical trial participants meet protocol specific eligibility criteria and provided informed consent according to federal and IRB regulatory guidelines.
9. Monitor adverse events for seriousness and facilitate the AE/SAE reporting process to ensure that all adverse events are reported to the study supporter and all participating site IRB’s.
10. Process new study subject registrations prior to enrollment.
11. Communicate with sites regarding the determinations made on behalf of the DSMC.
12. Oversee the maintenance and organization of project documentation and records.
13. Act as a liaison between the external clinical site(s), HCI parties (PI, regulatory team, study team, etc.) study sponsors and/or regulatory agencies and the research compliance office to resolve any issues that may arise throughout the course of the study.
14. Provides guidance and training to research faculty and staff pertaining to complex and highly specialized rules and regulations including complex protocol, multisite trials and IND/IDE issues.
15. Assists in the development of policies, procedures and process improvements for departmental implementation and guidance for external associates.
16. Other responsibilities may include but are not limited to: updating and revision of SOPs, training and orientation of study staff, organization of coordinator/investigator meetings.
17. Perform other duties as assigned by management.

This position utilizes federal, institutional guidelines and requirements to inform and complete submission of regulatory documents. This position also negotiates with University research committees and sponsors to ensure full compliance and communication.

The incumbent decides how to best accomplish the daily requirements of various regulatory objectives, prioritizes workload and establishes systems needed to achieve specific goals. Efforts of multiple departments or disciplines must be coordinated to ensure effective follow through and compliance of all involved following FDA, Good Clinical Practice, IRB, NIH, and/or other regulatory agency guidelines. Incumbent will be responsible for resolving and/or making appropriate recommendations for correction or full resolution to the Director and other members of the management team.

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.

• Experience in the management of clinical trials and the investigator initiated clinical development process.
• Oncology clinical trial experience highly preferred.
• Working knowledge of FDA requirements, OHRP, International Conference of Humanization (ICH) Good Clinical Practice (GCP), as well as state and federal guidelines.
• Knowledge of clinical development process sufficient to effectively direct and manage multiple projects and timelines.
• Strong attention to detail, establishing priorities, and adhering to deadlines.
• Able to show initiative and work independently, take initiative and complete tasks to meet deadlines.
• Excellent interpersonal communication (including oral and written) and leadership skills also required.
• Proficient in standard Microsoft office applications including Word, PowerPoint, Excel, Project, and other project management tools.

The University of Utah 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. 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.