Regulatory Specialist – Rsch Pro 2-Reg Affairs

University of Minnesota; Minneapolis (MN); On-site; USD 66,000 - 85,000; Full time

Benefits offered by this job

Competitive wages

Tuition benefit program

Low-cost health plans

HSA contributions

PSLF opportunity

Wellbeing program

Job summary

The Center for Pediatric Obesity Medicine (CPOM) at the University Of Minnesota seeks a full-time Regulatory Specialist to support clinical research projects, ensuring regulatory compliance, IRB submissions, and safety reporting. This on-site role reports to the Regulatory Manager under the Associate Director.

Responsibilities include managing the IRB lifecycle, maintaining regulatory files, coordinating with sponsors and FDA, and supporting quality assurance and DSMB activities.

Qualifications

• BA/BS degree plus at least two years of relevant experience, or a combination of education and relevant work experience to equal at least six years.
• Knowledge of Good Clinical Practice and CFR.

Responsibilities

• Regulatory Lifecycle & IRB Management: manage IRB lifecycle, submissions, consent/assent forms, and amendments.
• Maintain regulatory files and sponsor communications for audit-readiness.
• Prepare central IRB cede review submissions and ensure records are up to date.
• Research Operations & Compliance: monitor safety reporting to FDA, funders, and IRB within timelines.
• Maintain ClinicalTrials.gov timelines and provide enrollment updates to funders.
• Support DSMB planning and reporting, including DSMB charter and summaries.
• Quality Assurance Support: assist with internal/external audits and host visits.
• Administrative & Research Support: maintain training/licensing records and respond to site needs.

Skills

IRB Management

Regulatory compliance

FDA reporting

GCP knowledge

Documentation

Education

BA/BS degree

ACRP/SOCRA certification (preferred)

Job description

About The Job

About the Position

The Center for Pediatric Obesity Medicine (CPOM) in the Department of Pediatrics seeks a full-time Regulatory Specialist to support clinical research projects funded by federal agencies, industry partners, and other funders. CPOM is a nationally recognized team advancing evidence-based treatments for pediatric obesity.

This on-site position reports to the Regulatory Manager under the supervision of the Associate Director. The Specialist is responsible for the routine execution and maintenance of regulatory mandates, safety reporting, and quality assurance support. As the primary liaison with the Institutional Review Board (IRB), this role manages the full lifecycle of submissions and maintains official regulatory files for a large number of projects.

Key Responsibilities

Regulatory Lifecycle & IRB Management: 50%

• Determine which ancillary institutional applications/reviews are needed for a study and completing those applications and securing approval documentation for presentation to the IRB. Manage the IRB lifecycle: initiate applications, draft/submit consent and assent forms, and shepherd protocol amendments and annual reviews through reviews to study closure.
• Maintain the project regulatory files to ensure audit-readiness by maintaining IRB communications, maintaining and disseminating sponsor communications and third-party vendor communications, licensure, institutional training records, and ensuring the staff have current protocol and investigational product training completed.
• Prepares applications for the University of Minnesota IRB to cede review to a central IRB including completing institutional ancillary applications as part of the cede review process, managing the central IRB submission and providing central IRB approvals and continuing renewal information back to the UM IRB for their records.

Research Operations & Compliance: 20%

• Work with the study coordinators and study team to review unexpected findings at participant study visits, execute safety reporting for unexpected adverse events to the FDA, study funding agencies, and IRB within required timelines and manage those written records within the regulatory file. This position also reports protocol deviations to the UM IRB.
• Maintain project timelines in ClinicalTrials.gov and provide routine enrollment updates to funders and support offices within the University of Minnesota.
• Support the Data and Safety Monitoring Boards (DSMB) by assisting the PI with drafting the Data and Safety Monitoring Plan and DSMB Charter, disseminating summary reports from the DSMB, and informing the DSMB of safety reports. Maintain the DSMB reports and any responses and the IRB reporting of these activities. Maintaining the list of the DSMB members and their charter including any changes. Maintains the calendar of when the DSMB members need to convene and works with the administrative specialist in the Center to get those meetings scheduled.

Quality Assurance Support: 15%

• Along with study coordinators, assist with scheduling and hosting monitoring visits conducted by internal and external entities, help to resolve findings and report the visits to internal University partners.
• Serve as the primary host for internal audits conducted by the University of Minnesota Quality Assurance Program and for external audits conducted by study sponsors or the FDA.

Administrative & Research Support: 15%

• Maintain institutional training records (CITI GCP, HIPAA), licensure records including numerous out of state medical licenses, equipment certifications, and CLIA waivers for the Center. Maintain lab normal ranges, CAP and CLIA certifications, lab director CVs and licensure for our research collaborators.
• Assist with FDA IND/IDE annual reports and participate in site selection visits for new projects.
• Archive and destroy completed projects according to study destruction schedules.
• Assists with collecting pricing/securing services for potential future research endeavors.

Qualifications

All required qualifications must be documented on application materials

Required Qualifications

• BA/BS degree plus at least two years of relevant experience, or a combination of education and relevant work experience to equal at least six years
• Strong written, verbal, digital, and interpersonal skills
• Ability to work independently and with a team
• Proficiency with multitasking, prioritization, proofreading and attention to detail
• Knowledge of Good Clinical Practice and the Code of Federal Regulations

Preferred Qualifications

• Research regulation certification through the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA).

Pay And Benefits

Pay Range: $66,000 - $85,000/year depending on education/qualifications/experience

Time Appointment: 100% Appointment

Position Type: Civil-Service & Non-Faculty Labor Represented Staff

Please visit the Office of Human Resources website for more information regarding benefit eligibility.

The University Offers a Comprehensive Benefits Package That Includes

• Competitive wages, paid holidays, and generous time off
• Continuous learning opportunities through professional training and degree-seeking programs supported by the Regents Tuition Benefit Program
• Low-cost medical, dental, and pharmacy plans
• Healthcare and dependent care flexible spending accounts
• University HSA contributions
• Disability and employer-paid life insurance
• Employee wellbeing program
• Excellent retirement plans with employer contribution
• Public Service Loan Forgiveness (PSLF) opportunity
• Financial counseling services
• Employee Assistance Program with eight sessions of counseling at no cost
• Employee Transit Pass with free or reduced rates in the Twin Cities metro area

While our salary ranges provide a framework, it is important to note that most of the time, the initial pay may not reach the maximum of the range. This approach ensures that compensation reflects the value and unique contributions of each candidate while maintaining equity within our organization. As part of our commitment to fair and equitable compensation, please be aware that the salary offered to incoming candidates will be based on their individual credentials and experience.

Diversity

The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds.

The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu

Employment Requirements

Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.

About University Of Minnesota

The University of Minnesota, Twin Cities (UMTC)

The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.

At the University of Minnesota, we are proud to be recognized by Forbes as a Best Employer for Company Culture (2026), Best Employer for Women (2023, 2025, 2026), and Best Employer by State (2022-2026). In 2026, we also received Culture Excellence & Industry Awards recognition for employee appreciation and work-life flexibility.

The University of Minnesota Medical School

Committed to innovation and diversity, the Medical School educates physicians, scientists, and health professionals; generates knowledge and treatments; and cares for patients and communities with compassion and respect. We value excellence, inclusiveness, collaboration, and discovery.

The mission of the regional campus located in Duluth is to be a national leader in improving healthcare access and outcomes in rural Minnesota and American Indian/Alaska Native (AI/AN) communities. In partnership with CentraCare, the regional campus in St. Cloud offers a wide range of patient experiences throughout students’ education in Greater Minnesota and prepares them to become exceptional clinicians and leaders for rural and immigrant populations.

Founded in 1888, the University of Minnesota Medical School has three campuses. A four-year MD program and the MD/PhD program are located on the Twin Cities campus in addition to MD programs at regional campuses in Duluth and St. Cloud.