Regulatory Specialist

About the Job: The Epilepsy Institute in the Department of Neurology is hiring a Regulatory Specialist (Research Professional 2) for an interdisciplinary array of clinical research studies ranging from pre-clinical animal and lab studies, pharmacological treatments, and/or medical devices. Teamwork and cross-collaboration is very important in this role as it will involve interactions with internal (e.g., Fairview, UMP, etc.) and external (e.g., Sponsors, FDA, etc.) groups. We welcome candidates with attention to detail who have excellent written, verbal, and interpersonal communication skills. These studies involve working with Principal Investigators in Neurology, Neurosurgery, Pharmacy, Biomedical Engineering, Radiology, and Veterinary Medicine.

Location/Work Environment: This is expected to be a hybrid position, with some work on-campus (University of Minnesota-Twin Cities) and remote.

Work Schedule: Monday - Friday, between the hours of 7:30am - 5:00pm, flexible scheduling, 8 hours/day.

Duties/Responsibilities:

100% Regulatory:
1) Perform regulatory processes necessary to make clinical trials available to patients following federal regulations (CFR), Good Clinical Practice (GCP), and internal (University) and external (Sponsor) policies. (90%) This includes:
a. Creating and maintaining regulatory documents from initial submission through study closure;
b. Creating and modifying participant informed consent forms, including HIPAA authorization forms, and other protocol-adjacent documents;
c. Initiating and maintaining correspondence with Institutional Review Boards (IRB) and/or Institutional Animal Care and Use Committees (IACUC);
d. Addressing issues of study rationale, implementation, and integrity monitoring;
e. Acting as a liaison between the study team (this includes but is not limited to the Principal Investigator, Research Managers, University departments, external sponsors, clinical partners and collaborators);
f. Other regulatory management duties as assigned.

2. Monitoring trends in regulatory/protocol processes and making recommendations for improvement. (5%)

3. Providing education, training and serving as a resource to improve research compliance. (5%)

Required Qualifications:
* BA/BS degree plus at least two (2) years of work experience or a combination of education and relevant work experience to equal at least six (6) years
* Knowledge of clinical research compliance standards (e.g., Code of Federal Regulations (CFR), Good Clinical Practices (GCP), etc.);
* Ability to work collaboratively with internal and external stakeholders;
* Experience making decisions, problem solving and prioritization;
* Organized with excellent attention to detail;
* Ability to take initiative and keep track of duties independently, under general supervision;
* Excellent verbal, written and interpersonal skills;
* Computer proficiency and ability to navigate multiple software applications;

Preferred Qualifications:
* Experience in neurology, neuroscience, public health, psychology, or biomedical research;
* Experience with business & industry clinical trials;
* Experience with FDA-regulated clinical trials;
* Familiarity with the research policies and procedures at the University of Minnesota and its internal collaborators (e.g., Fairview and/or UMP);
* Certified clinical research professional (e.g., SOCRA or ACRP).

The Epilepsy Institute is a first-of-its-kind institute created to change the trajectory of epilepsy itself. By uniting precision care, personalized therapies, and preventive neuroscience within a single bold mission, the Institute will transform how epilepsy is treated today and redefine what is possible tomorrow. It will serve as a global home for discovery, innovation, and education-where clinical insight fuels scientific breakthroughs, and breakthroughs rapidly return to patients.

To learn more, please visit https://med.umn.edu/neurology.

Pay Range: $32.69/hr - $37.50/hr; 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

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).