Regulatory Specialist - Rsch Pro 2-Reg Affairs

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.

Key Responsibilities:

Regulatory Lifecycle & IRB Management: 50%

• Manage the IRB lifecycle: initiate applications, draft/submit consent and assent forms, and shepherd protocol amendments through reviews and to study closure.
• Maintain the official project regulatory files, ensuring audit-readiness with current licenses and training records.
• Coordinate with stakeholders and ancillary review committees to ensure appropriate participant-facing language and institutional compliance.

Research Operations & Compliance: 20%

• Execute safety reporting for unexpected adverse events to the FDA, funders, and IRB within required timelines.
• Maintain project entries in ClinicalTrials.gov and provide routine enrollment updates to funders.
• Support the Data and Safety Monitoring Boards (DSMB) by disseminating summary reports and safety information.

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.

Administrative & Research Support:15%

• Maintain institutional training records (CITI, GCP, HIPAA), licensure records, equipment certifications, and CLIA waivers.
• Assist with IND/IDE applications and participate in site selection visits for new projects.
• Archive and destroy completed projects according to study timelines
• Participate in site selection visits for potential new projects
• Assists with collecting pricing/securing services for potential future research endeavors

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

Time Appointment: 100% Appointment

Location: On-Site (717 Delaware Street)

Position Type: Civil-Service

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.

Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume.

Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section.

To request an accommodation during the application process, please e-mail employ@umn.edu or call (612) 624-8647.

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

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.

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), 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.