University of Minnesota Looking for Regulatory Specialist – RP3 (# 357677) Full Time

About the Job

The MnDRIVE DBS Core at the University of Minnesota is seeking
a regulatory specialist. (MnDRIVE is Minnesota’s Discovery, Research, and InnoVation Economy – a partnership between the University
of Minnesota and the State of Minnesota.) The MnDRIVE DBS Core supports research protocols at the University of Minnesota that are related
to invasive neuromodulation; examples include deep brain stimulation (DBS) for OCD, depression, or Parkinson’s disease, or spinal cord
stimulation for pain. Most of the protocols that the regulatory specialist will be supporting are designed to recruit participants who
already have DBS devices implanted as part of their regular clinical care. A few protocols are FDA-regulated device studies; the
ideal candidate will have prior experience handling regulatory paperwork and FDA correspondence for this type of
study, but we will
provide training if necessary. 

The University has a flexible policy regarding working remotely. However, this is not a fully remote
position; most studies have fully electronic regulatory files, but some older studies still have paper binders. Some meetings may be
required to be in person. The amount of time spent remote vs. in person will vary, and will be determined by your duties in a given week.
You will be provided with a UMN laptop to enable you to carry out remote work securely. 

We are seeking highly motivated candidates
with strong organizational and interpersonal skills and who have a high level of professionalism. We will provide training for those
unfamiliar with the various platforms involved in regulatory work at the University of Minnesota

Job
Duties/Responsibilities:
Duties include but are not limited to providing:

1) Regulatory Processes for Opening New Projects
(40%)
* Create regulatory files for new studies;
* Complete IRB and other required review committee applications on assigned
protocols;
* Draft study-related informed consent documents according to Sponsor and University requirements;
* Provide guidance and
direction to team in order to ensure regulatory compliance
* Draft study-related correspondence, including preparing FDA submissions, for
study PI;
* Create and maintain all required documents for assigned regulatory binders;
* Assist PIs, Core Manager and Project Manager
with coordination of all activities relative
to initiation of assigned projects;
* Communicate with all University and hospital
departments to collect needed information
for initiating new projects and opening new study research accounts.
* Assist PIs, project
managers, and coordinators in preparation for audits/monitoring visits

2) Regulatory Processes for Continued Management of Active
Projects (50%)
* Facilitate continuing review compliance for IRB and annual reports for FDA and Sponsors
* Process study amendments,
including protocol and consent changes, for PIs and study coordinators
* Track and communicate changes to protocol specific
requirements
* Prepare for and assist with internal and external monitoring visits
* Archive study materials when appropriate
*
Update REDCap e-consent, Florence eBinders, OnCore as appropriate
* Serve as a Florence superuser; provide guidance and support

3)
Process Improvement (10%)
* Make recommendation for improvements to processes and initiate process improvement
* Communicate changes
to processes in a clear and professional manner
* Assist in the development of SOPs for regulatory processes
* Enter information into
study management databases (e.g., OnCore)
* Monitor trends in regulatory/protocol processes and makes recommendations for
improvement
* Assist with monitoring according to Core and Department procedures
* Track and assist with implementing changes in
regulatory processes as needed
* Participate in training of new staff as needed
* Fulfill special requests for data management and
other duties as needed

Qualifications

All required qualifications must be documented on application
materials

Required Qualifications:
* BA/BS with at least 4 years of experience or advanced degree plus 2 years of experience or a
combination of education and work experience to equal 8 years;

Preferred Qualifications:
* Minimum of one (1) year experience in
clinical research setting
* Working experience in the preparation of IRB applications
* Working knowledge of regulations governing
research activities (such as GCPs, FDA  regulations and ICH guidelines)
* Demonstrated ability to initiate, process, and track multiple
projects simultaneously
* Experience with Office Suite, Google Apps, and web-based systems for tracking activities,
calendaring, and
retrieving/updating information.
* Possess excellent communication skills; verbal and written.
* Demonstrated ability to provide
excellent customer service to internal and external clients
* Professional experience on a clinical research project team
* Experience
in an academic health center
* Experience with medical devices (e.g., IDEs)
* Knowledge of medical terminology
* Certification as a
clinical research professional with SoCRA or ACRP or willingness to obtain certification at time of eligibility.
* Experience with
REDCap, OnCore, Asana, and/or Florence

Benefits

Working at the University

At the
University of Minnesota, you’ll find a flexible work environment and supportive colleagues who are interested in lifelong learning.  We
prioritize work-life balance, allowing you to invest in the future of your career and in your life outside of work.

The University
also 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 Scholarship
• 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

Please visit the Office of Human Resources website for more information regarding
benefits.

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 “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 [email protected] or call (612) 624-UOHR
(8647).

Diversity

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

Employment
Requirements

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.

About the U of M

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).