Job Listing
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| Job ID: 13943207 |
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| Job Location: |
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| How to Apply: | To see employer contact information, log in or register. |
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| Job Title: | Regulatory & Outreach Specialist (Research Professional 2) |
| Work Type: | Work Days: Work Vary: Yes , Shift: Other, Hours Per Week: 40, Work Type: Regular |
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| Salary Offered: | Unspecified |
| Benefits: | Unspecified. |
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| Physical Required: | Unspecified |
| Drug Testing Required: | Unspecified |
| Education Required: | Bachelor's Degree |
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| Experience Required: | Unspecified |
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| Required Skills: | Please see the job description for information about required job skills. |
| Preferred Skills: |
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| Job Description: |
Job ID359763
LocationTwin Cities
Job FamilyResearch-Support
Full/Part TimeFull-Time
Regular/TemporaryRegular
Job Code8352P2
Employee ClassCivil Service
About the Job
Job Duties/Responsibilities:
1) Regulatory work (55%)
- Create regulatory files for new studies
- Complete IRB and other required review committee applications
- Draft study-related documents
- 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 and/or continuation of assigned projects
- Communicate with all University and hospital departments 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
- Process study amendments, including protocol and consent changes
- Track and communicate changes to protocol specific requirements
- Update REDCap e-consent, Florence eBinders, OnCore
2) Outreach Coordinator (30%)
- 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
- Distribute (and potentially design) promotional items at outreach events
- Coordinate social media presence for the DBS Core
3) Study monitoring and process improvement (15%)
- 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 checklists in project management software
- Monitor trends in regulatory/protocol processes and makes recommendations for
improvement
- Fulfill special requests for data management and other duties as needed
- Prepare for and assist with internal and external monitoring visits
- Assist PIs, project managers, and coordinators in preparation for audits/monitoring visits
Qualifications
Required Qualifications:
- BA/BS with at least 2 years of related experience or a combination of education and work experience to equal 6 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
- Experience in public outreach, web design, and/or social media
About the Department
The Department of Neurology at the UMN is home to 58 faculty members (48 MD's, 10 PhDs) and is organized in nine Divisions (General Neurology, Movement Disorders, Neuromuscular, Epilepsy, Stroke, Neurocritical Care, Memory, Multiple Sclerosis and Pediatric Neurology) along with expertise in Sleep Medicine and Neuro-oncology.
The Department's educational and training programs include an adult neurology residency with 24 residents and seven different fellowship programs (Vascular Neurology, Endovascular
Surgical Neuroradiology, Critical Care Neurology, Epilepsy, Neuromuscular Medicine, Clinical Neurophysiology and Movement Disorders). The Department is home to seven NIH-funded
researchers whose funding includes an NINDS P50 Udall Center of Excellence for Parkinson's Disease Research and an NINDS StrokeNet Regional Coordinating Center.
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
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)
Financial counseling services
Employee Assistance Program with eight sessions of counseling at no cost
with free or reduced rates in the Twin Cities metro area
Please visit the 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 employ@umn.edu or call (612) 624-8647.
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:
Employment Requirements
Any offer of employment is contingent upon the successful completion... For full info follow application link.
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.
Refer to ID 78346454 when applying |
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