Regulatory Specialist

Apply for Job Job ID371198 LocationTwin Cities Job FamilyResearch Full/Part TimeFull-Time Regular/TemporaryRegular Job Code8352RF Employee ClassCivil Service Add to Favorite Jobs Email this Job About the Job Position Summary: The Department of Neurology is seeking a Regulatory Specialist to assist with initiation and maintenance of clinical research studies in the Clinical Neuroscience Research Unit (CNRU) and the Department. This role will provide regulatory support for new and ongoing clinical research studies for neurological disorders, including neuromuscular diseases (e.g., ALS, muscular dystrophies, neuropathies), multiple sclerosis, movement disorders, sleep disorders, headache, Alzheimer's disease, and epilepsy. Responsibilities/Duties: 100% - Perform regulatory processes necessary to make clinical trials available to patients following federal regulations, sponsor and University policies. This includes: Creating and maintaining regulatory documents, including initial submission through study closure. Creating and adapting participant consent forms, assent forms, and HIPAA authorization forms in compliance with sponsor and local standards. Acting as a liaison between Principal Investigator, Research Support Manager, University departments, outside sponsors, clinical partners and collaborators. Initiating and maintaining correspondence with the Institutional Review Board (IRB). Addressing issues of study rationale, implementation, and safety monitoring. Monitoring trends in regulatory/protocol processes and making recommendations for improvement. Providing guidance to ensure regulatory documents are filed and archived. Providing education, training and serving as a resource to improve research compliance. Other duties as assigned. Qualifications 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., informed consent process, 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 prioritizing clinical research duties. Organized with excellent attention to detail. Excellent verbal, written and interpersonal skills. Computer proficiency and ability to navigate multiple software applications. Preferred Qualifications: Experience with business & industry clinical trials. Familiarity with the research policies and procedures at the University of Minnesota, University of Minnesota Medical Center, Fairview Hospitals and Clinics. Certified clinical research professional (e.g., SoCRA or ACRP). About the Department To learn more about the Department of Neurology, please visit Pay and Benefits Pay Range: $33.65/hr - $48.08/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 How To Apply 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

Created: 2025-11-24