Regulatory Affairs Specialist

About the Job

Join a team that sits at the heart of advancing clinical research at the University of Minnesota. The Regulatory Affairs Specialist is a trusted institution subject matter expert who ensures our studies meet the highest standards of compliance, preventing fines and inspection findings while helping investigators bring forward discoveries that can change lives.

In this role, you'll balance precision with collaboration, preparing FDA submissions, managing Clinical Trials.gov records, and advising research teams across the institution. You'll also contribute to process improvements that make regulatory compliance not only possible, but efficient and sustainable.

The individual who will thrive in this role has a strong attention to detail, a drive to follow best practices, strong written and verbal communication skills, and a talent for rapid response times to tasks and inquiries.

This position follows UMN Work. With Flexibility. guidelines. Currently, the position is a 40 hrs/wk, 1.0

FTE primarily working from home, with in-office days as needed. There may be occasional needs to be on campus and over time there may be a need to set a regular schedule for more days on campus each week. Work hours should follow a regular schedule with flexibility between 7-5, M-F.

40%: FDA Submission Support

• Prepare and submit initial IND/IDE applications, amendments, and reports.
• Guide study teams on Emergency Use and Expanded Access submissions.
• Advise study teams on submission pathways and requirements.
• Provide protocol feedback at weekly feasibility reviews based on IRB review trends.
• Partner with HRPP leadership to ensure compliance and appropriate decision-making.

50%:
Clinical Trials.gov Support

• Manage record registration and updates, securing NCT numbers and resolving PRS problems quickly.
• Monitor daily for record issues and needed follow-up, escalating when needed.
• Run monthly planning reports to stay ahead of strict deadlines.
• Maintain meticulous records of all reach-outs, follow-up, and escalation.
• Communicate deadlines and potential consequences of noncompliance to study teams.
• Conduct IRB ancillary reviews of registration requirements.
• Partner with RIO leadership to ensure compliance and appropriate escalation, including preparing a monthly non-compliance report.

10%:
Metrics Reporting & Process Improvement

• Maintain real-time study trackers and deliver both quarterly and on-demand metrics.
• Drive workflow improvements, coordinating with CTSI, HRPP, and RIO colleagues.
• Monitor changes in federal regulations and adapt processes as needed.
• Provide educational materials and trainings to the research community.
• Other duties as assigned.

All required qualifications must be documented on application materials.

Required Qualifications

• Bachelor's degree + 6 years experience in clinical research or an advanced degree + 4 years experience in clinical research.
• Demonstrated ability to lead and drive initiatives to completion.
• Demonstrated ability to solve complex problems independently.
• Demonstrated expertise in clinical research regulations and guidance, with emphasis on the Code of Federal Regulations.

Preferred Qualifications

• Familiarity with academic medical centers, University of Minnesota systems and processes strongly preferred.
• Technical aptitude working with PRS, OnCore, Florence eBinders, and ETHOS.
• Proactive verbal and written communication skills.
• Experience working collaboratively with individuals across functions and teams.
• Ability to navigate and prioritize among competing priorities.

The University of Minnesota Clinical and Translational Science Institute (CTSI) mission is to accelerate and improve clinical and translational science research, education and improve health. CTSI provides consultation, training, support, and services to researchers and research teams across the translational continuum. CTSI is part of the national, NIH-funded Clinical Translational Science Award (CTSA) program/consortium that works together to improve the efficiency, quality, and impact of clinical and translational research and science.

Pay Range: $92K-$102K;…