Regulatory Specialist - Rsch Pro -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.

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 Clinical Trials.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%)

• Assist with scheduling and hosting monitoring visits conducted by internal and external entities, help 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.
• Assist 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

Benefits include:

• 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…