Regulatory Project Manager

Details

Open Date 10/07/2026

Requisition Number PRN46421B

Job Title Clinical Project Managers

Working Title Regulatory Project Manager

Career Progression Track P00

Track Level P2 - Developing, P1 - Entry Level Pro

FLSA Code Administrative

Patient Sensitive Job Code? Yes

Standard Hours per Week 40

Full Time or Part Time? Full Time

Shift Day

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.

VP Area U of U Health - Academics

Department 00857 - Pediatric Hematology/Oncology

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range $46,584 - $76,593

Close Date 01/07/2027

Priority Review Date (Note - Posting may close at any time)

Job Summary

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.

This position is posted at multiple job levels. Each level has distinct qualifications, responsibilities, which will be evaluated during the selection process. Final placement, including the associated pay rate, will be determined based on business needs and budget considerations.

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:

The University of Utah offers a comprehensive benefits package including:

• Excellenthealth care coverageat affordable rates (see theSummary Comparisonfor more information)

• 14.2% retirement contributions

• Generouspaid leave time

• 11 paid Holidaysper year

• 50% tuition reductionfor employees, spouses, and dependent children

• Flex spending accounts

• University providedbasic employee life insurancecoverage equal to a salary of up to $25,000

• Variety of electiveinsurance coverage, including life insurance, short and long-term disability, accidental death & dismemberment, accident, critical illness, hospital indemnity, and pet.

• Free transiton 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 athttps://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.

The following job levels and associated pay rates will be considered based on job placement. Final placement, including the corresponding pay rate, will be determined by the department in alignment with business needs and budget considerations.

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

EQUIVALENCY STATEMENT : 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

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.

Type Benefited Staff

Special Instructions Summary

Additional Information

The University is a participating employer with Utah Retirement Systems (“URS”). Eligible new hires with prior URS service, may elect to enroll in URS if they make the election before they become eligible for retirement (usually the first day of work). Contact Human Resources at (801) 581-7447 for information. Individuals who previously retired and are receiving monthly retirement benefits from URS are subject to URS’ post-retirement rules and restrictions. Please contact Utah Retirement Systems at (801) 366-7770 or (800) 695-4877 or University Human Resource Management at (801) 581-7447 if you have questions regarding the post-retirement rules.

This position may require the successful completion of a criminal background check and/or drug screen.

The University of Utah values candidates who have experience working in settings with students and possess a strong commitment to improving access to higher education.

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.

Consistent with state and federal law, 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. Inquiries about the application of Title IX and its regulations may be referred to the Title IX Coordinator, to the Department of Education, Office for Civil Rights, or both.

To request a reasonable accommodation for a disability or if you or someone you know has experienced discrimination or sexual misconduct including sexual harassment, you may contact the Director/Title IX Coordinator in the Office of Equal Opportunity and Title IX ( OEO ). More information, including the Director/Title IX Coordinator’s office address, electronic mail address, and telephone number can be located at the:University of Utah Non‑Discrimination page.

Online reports may be submitted athttps://oeo.utah.edu

**https://publicsafety.utah.edu/safetyreport/**This report includes statistics about criminal offenses, hate crimes, arrests and referrals for disciplinary action, and Violence Against Women Act offenses. They also provide information about safety and security-related services offered by the University of Utah. A paper copy can be obtained by request at the Department of Public Safety located at 1658 East 500 South.

As perUniversity of Utah policy 5-108: Transfer of Benefits Eligible Staff Members, a new hire to the University of Utah who is still serving a 12 month probationary period will not be hired into another University of Utah job (a transfer) until the successful completion of the probationary period.