Outreach and Regulatory Specialist

The University has a flexible policy regarding working remotely. However, this is not a fully remote position; some meetings may be required to be in person, some files are located on campus, and outreach events must be attended 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. Mileage to outreach events will be reimbursed.

Job Responsibilities:
1) Outreach Coordinator (70%)
-Several times a year, attend public outreach events (e.g. Parkinson's Awareness Day at Target Field, APDA "Optimism Walk") to provide the public with information about neuromodulation research at UMN and to recruit participants
-Coordinate UMN team presence at neuromodulation-related public outreach events
-Track attendance and outreach activities
-Build and maintain databases for recruitment purposes
-Submit regulatory paperwork for outreach-related databases and activities
-Coordinate with web developer to update and maintain DBS Core website
-Design written materials for the DBS Core to distribute at outreach events, along with written materials provided by other labs
-Design and distribute promotional items at outreach events
-Coordinate social media presence for the DBS Core
-Write a monthly newsletter with theMnDRIVE Core's associate director
-organize a small annual symposium

1) Regulatory work (20%)
-Complete IRB and other required review committee applications
-Draft study-related documents
-Provide guidance and direction to team in order to ensure regulatory compliance
-Communicate with all University and hospital departments (and potentially with external agencies) to collect needed information for initiating new projects and opening new study research accounts.
-Facilitate continuing review compliance for IRB and annual reports for FDA and sponsors
-Track and communicate changes to protocol-specific requirements
-Update REDCap e-consent, Florence eBinders, OnCore

3) Study monitoring and process improvement (10%)
-Make recommendation for improvements to processes and initiate process improvement
-Communicate changes to processes in a clear and professional manner
-Fulfill special requests for data management and other duties as needed
-Prepare for and assist with internal and external monitoring visits

All required qualifications must be included in the application materials

Required Qualifications:
-BA/BS with at least 2 years of experience or a combination of education and work experience to equal 6 years

Preferred Qualifications:
-Excellent attention to detail
-Minimum of one (1) year experience in clinical research setting
-Experience in public outreach, web design, and/or social media
-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

The MnDRIVE DBS Core supports research at the University of Minnesota that is related to invasive neuromodulation; examples include deep brain stimulation (DBS) for OCD, depression, or Parkinson's disease, or spinal cord stimulation for pain. You do not need to have experience in invasive neuromodulation to apply for this position. Initial training will be provided and
customized to your needs. Ongoing continuing education and career development are a part of our welcoming, supportive work environment. The DBS Core is comprised of an Associate Director, Project Manager, Coordinator, and Regulatory Specialist. We are a close-knit team who work together to help investigators across the University.

To learn more please visit our website at https://med.umn.edu/neurology

• 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).