"PS Regulatory Coordinator"

PS Regulatory Coordinator

Job Summary

The Department of Pediatrics, Division of Pediatric Neurology, at the University of Utah School of Medicine has an immediate opening for a Clinical Research Regulatory Coordinator. This position develops and coordinates the submission of regulatory documents to ensure compliance with governing requirements. Oversees research study documents in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies.

The University of Utah offers a comprehensive benefits package including:

• Excellent health care coverage at affordable rates (see the Summary Comparison for more information)
• 14.2% retirement contributions that vest immediately
• Generous paid leave time
• 11 paid Holidays per year
• 50% tuition reduction for employees, spouses, and dependent children
• Flex spending accounts
• University provided basic employee life insurance coverage equal to a salary of up to $25,000
• Variety of elective insurance coverage, including life insurance, short and long-term disability, accidental death & dismemberment, accident, critical illness, hospital indemnity, and pet.
• Free transit on most UTA services
• Employee discounts on a variety of products and services, including cell phones & plans, entertainment, health and fitness, restaurants, retail, and travel
• Professional development opportunities

Additional benefits information is available at https://benefits.utah.edu/.

Responsibilities

Essential Functions

1. Supports all aspects of regulatory compliance.
2. Prepares regulatory documents, including consent forms for submission to research review committees.
3. Communicates with research committees and administrative units, project sponsors and project staff to ensure accuracy of regulatory documents and submissions.
4. Tracks study approvals and expirations to ensure uninterrupted project approval.
5. Tracks sponsor and investigator-initiated amendment notifications and submits amended protocols, summaries and consents to the Institutional Review Board (IRB).
6. Submits study start-up applications, renewal applications and study progress reports to the IRB.
7. Coordinates with study sponsor, investigator and IRB to complete study closure activities.
8. Assists investigators and others involved in clinical research with process and policy issues and provides guidance on form preparation and submission.
9. Recommends and implements regulatory process improvements.
10. Maintains current knowledge of federal and institutional guidelines and requirements governing research.
11. Maintains regulatory database.
12. Generates ad hoc reports as requested.

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. Work Environment and Level of Frequency that may be required: Nearly Continuously: Office environment. Seldom: Infectious disease, oils (there is air or skin exposure to oils or other cutting fluids). Physical Requirements and Level of Frequency that may be required: Nearly Continuously: Hearing, listening, talking. Often: Repetitive hand motion (such as typing), walking, standing, sitting. Seldom: Bending, reaching overhead.

Minimum Qualifications

Bachelor's degree in a research or related area plus two years clinical trials/research experience or equivalency (one year of education can be substituted for two years of related work experience) required; demonstrated human relations and effective communication skills also required.

One year of regulatory experience, an understanding of medical terminology and technical writing experience preferred.

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

Department Specific Preferences

• Three or more years of industry sponsored clinical trials experience is preferred.
• Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; extensive understanding of research procedures.
• Experience with Medical Record Coding, familiarity with EMR and medical record structure and data location, proficiency in computers and software applications (MS Access), detail oriented, critical thinking skills is preferred.
• Self-motivated and flexible.

Applicants will be screened according to preferences.

Special Instructions

Requisition Number: PRN43374B
Full Time or Part Time? Full Time
Work Schedule Summary: 40 hours per week; availability Monday through Friday, 7:30 a.m. - 5:30 p.m.
Department: 00848 - Pediatric Administration
Location: Campus
Pay Rate Range: $39,300 - $68,349
Close Date: 1/21/2026
Open Until Filled: