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:
Under supervision and the direction of the Research Manager, the regulatory specialist’s duties include but are not limited to:
1) Regulatory Processes for Opening New Projects (40%)
- Coordinate the initiation of the regulatory files for new studies;
- Assist with the completion of the IRB and other required review committee applications on assigned protocols;
- Assist with drafting the study-related informed consent documents according to Sponsor and University requirements;
- Recommend guidance and direction to team in order to ensure regulatory compliance
- Assist with study-related correspondence, including preparing FDA submissions, for study PI;
- 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%)
- Ensure 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
- Assist with the preparation of internal and external monitoring visits
- Archive study materials when appropriate
- Update REDCap e-consent, Florence eBinders, OnCore as appropriate
- Once trained, serve as a Florence superuser; provide guidance and support

3) Process Improvement (10%)
- Make recommendation for improvements to processes and initiate process improvement
- Assist with the communication of 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
-T rack 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

All required qualifications must be documented on application materials

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

Preferred Qualifications:
- Previous experience in clinical research setting
- Working experience in the preparation of IRB applications
- Some 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
 

About University of Minnesota Twin Cities

The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.

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