Regulatory Affairs Specialist

Regulatory Affairs Specialist
9791RF

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 ClinicalTrials.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.

Duties/Responsibilities

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%: ClinicalTrials.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; depending on education/qualifications/experience

Time Appointment: 100% Appointment

Position Type: P&A 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

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 the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America's Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022).