Regulatory Specialist

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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).

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.

To learn more about the Department of Neurology, please visit https://med.umn.edu/neurology.

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).

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