Regulatory Project Manager

University of Utah; Salt Lake City (UT); Hybrid; USD 47,000 - 77,000; Full time

Benefits offered by this job

Healthcare coverage

14.2% retirement contributions

Paid leave time

11 holidays per year

50% tuition reduction

Job summary

University of Utah is seeking a Regulatory Project Manager in the Department of Pediatrics to oversee regulatory management for clinical studies, ensuring FDA/IRB and sponsor compliance from start-up to close-out.

Responsibilities include regulatory document preparation, submissions, adverse event reporting, and coordinating with sponsors, investigators, and departments. Hybrid work and opportunities for process improvements are offered.

Qualifications

• Bachelor's degree (or equivalent) with up to 2 years of related work experience, or master's with equivalent.
• ACRP/SOCRA certification preferred.

Responsibilities

• Coordinate all aspects of clinical studies from initiation through delivery.
• Prepare protocol worksheets, IRB documents, and progress reports.
• Maintain regulatory files and TMF; ensure compliance with regulations.
• Provide regulatory guidance and training to study teams.

Skills

Directly related work experience

ACRP/SOCRA Certification

Education

Bachelor's degree (or higher)

Job description

Regulatory Project Manager

Job Summary

The Division of Hematology, Oncology, BMT has an immediate opening for a Regulatory Project Manager, in the Department of Pediatrics at the University of Utah Spencer F. Eccles School of Medicine. This role is responsible for the comprehensive regulatory management of clinical research studies, ensuring compliance with FDA, IRB, institutional, sponsor, and consortium requirements from study start-up through closeout. Key responsibilities include preparing and submitting regulatory documents and IRB applications, managing study amendments, continuing reviews, adverse event reporting, protocol deviations, consent form updates, and study activation and closure activities. The position maintains regulatory files, study records, training and delegation logs, tracks approvals and expirations, coordinates with sponsors, investigators, research teams, and institutional departments, and supports monitoring visits, audits, and quality assurance activities. The role also provides regulatory guidance to study teams, facilitates communication among stakeholders, drives process improvements, ensures accuracy of research systems and documentation, and mentors research staff while supporting departmental operations and cross-functional study activation efforts.

Department Summary

The Department of Pediatrics is the second largest department in the University of Utah School of Medicine and one of the largest pediatric departments in the country. We are committed to improving the lives of children through excellence in advocacy, education, research, and clinical care. For more information about the Department of Pediatrics, please visit: http://medicine.utah.edu/pediatrics/. Mutual respect and appreciation are highly valued in the department.

Benefits Summary

• Excellent healthcare coverage at affordable rates (see the SummaryComparison for more information)
• 14.2% retirement contributions
• 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/.

Employee Health Requirements

This position is patient-sensitive and must fulfill all associated vaccination requirements, or be approved for an exemption, prior to the first day of work. 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.

Responsibilities

Essential Functions

Coordinate all aspects of clinical studies from initiation through delivery. Build and maintain relationships with sponsors, investigators, and research staff. Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports. Maintain required records and ensure compliance with protocols, regulatory regulations, and overall clinical objectives. Record adverse event and side effect data and confer with investigators regarding reporting of events to oversight agencies. Utilize project management methodologies, lead cross-functional teams, resolve issues within the clinical study, and ensure that all targets, timelines, budgets, and requirements are met.

1. Regulatory Compliance: Adheres to federal, local, and institutional regulations, laws, guidelines, and standards. Stays informed on any changes and communicates applicable changes to the research team.
2. Project/Study Management: Coordinates all study startup activities and activation. Maintains study regulatory and study management activities from activation to close-out. This includes regularly coordinating with study sponsor/consortium, investigators, research team, and any other teams/groups applicable to a specific study. Manages multiple studies at a time.
3. Institutional Review Board (IRB) Submissions: Prepares and maintains all IRB submissions and approvals including: initial submission, amendments, continuing/annual reviews, deviations, report forms, progress reports, AE and SAEs, etc. Tracks IRB expiration dates. Coordinates with a Single IRB (SIRB), when applicable.
4. Regulatory Documentation: Prepares and maintains all essential regulatory and site-specific study documents. Including, but not limited to: FDA Form 1572, financial disclosure forms, informed consent documents, delegation logs, training logs, etc. Creates and maintains site Trial Master File (TMF), storing all study documents. Maintains and monitors all research staff's credentials and essential trainings (e.g. Good Clinical Practice (GCP) and Human Subjects Protections (HSP)).
5. Monitor Visits: Coordinates and facilitates study monitor visits, inspections, and audits such as site feasibility, site initiation, interim monitor visits, audits, inspections, and close-out visits.
6. Training and Guidance: Assist with training and mentoring of new team members. Provides protocol and amendment training to applicable study teams. Coordinates any other required study-specific trainings. Provides regulatory guidance to ensure compliance with regulations and standards.

Clinical Project Manager, I

Requires basic skill set and proficiency. Conduct work assignments as directed. Closely supervised with little latitude for independent judgment.

Requires a bachelor's (or equivalency) with up to 2 years of directly related work experience or a master's (or equivalency) degree. This is an Entry-Level position in the General Professional track.

Clinical Project Manager, II

Requires moderate skill set and proficiency in discipline. Conducts work assignments of increasing complexity, under moderate supervision with some latitude for independent judgment.

Requires a bachelor's (or equivalency) + 4 years or a master's (or equivalency) + 2 years of directly related work experience. This is a Developing-Level position in the General Professional track.

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.

Minimum Qualifications

1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelor's degree = 4 years of directly related work experience).

Department may hire employee at one of the following job levels:

Clinical Project Manager, I

Requires a bachelor's (or equivalency) with up to 2 years of directly related work experience or a master's (or equivalency) degree.

Clinical Project Manager, II

Requires a bachelor's (or equivalency) + 4 years or a master's (or equivalency) + 2 years of directly related work experience.

Preferences

• At least 2 years of directly related work experience (or equivalency).
• ACRP/SOCRA Certification.

The Department will screen applicants according to the identified preferences.

Special Instructions

Requisition Number

PRN46421B

Full Time or Part Time

Full Time

Work Schedule Summary

Monday – Friday, between 8:00 a.m. –5:00 p.m. Hours may vary based on operational needs. Opportunities for a hybrid three-day weekly telework schedule may be considered after the initial training period, provided the arrangement is supported by operational needs and individual performance. Telework arrangements are not guaranteed and may be modified or discontinued at any time based on business requirements or performance. Employees approved for hybrid telework must provide their own private workspace, secure internet connection, and demonstrate the ability to work independently.

Department

00857 - Pediatric Hematology/Oncology

Location

Campus

Pay Rate Range

$46,584 - $76,593

Close Date

01/07/2027