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Apply for Job Job ID353888 LocationTwin Cities Job FamilyResearch-Support Full/Part TimeFull-Time Regular/TemporaryRegular Job Code9354S1 Employee ClassAcad Prof and Admin Add to Favorite Jobs Email this Job About the Job The Translational Neural Engineering Laboratory (http://www.tnelab.org) in the University of Minnesota Department of Psychiatry is seeking a Research Support Manager 1 - Clinical Research Scientist - to lead multiple trials of advanced brain stimulation therapies for brain disorders. Our laboratory develops technologies for treating a variety of serious illnesses, including PTSD, major depression, addiction, and obsessive-compulsive disorder. Most of our work involves "responsive" or "closed loop" technologies that sense and respond to patients' brain activities. Studies either ongoing or starting up, which would be part of your portfolio, include: Deep brain stimulation for obsessive-compulsive disorder Closed-loop invasive neurostimulation for severe depression Invasive neurostimulation for chronic central pain (such as post-stroke or facial pain) Biomarkers of suicidality recorded from the electroencephalogram Cognitive biomarkers of transcranial magnetic stimulation for depression Non-invasive brain stimulation to improve emotional resilience We are specifically seeking a candidate who has clinical experience with brain or nervous system disorders and an interest in ongoing clinical work in this space. We hope to make this a long-term role, sustained by ongoing developments in the above spaces and expansion into new indications. We can train on all of the job functions below, and will then expect you to be able to work at a high level of independence, in many cases substituting for the laboratory principal investigator(s). Job Responsibilities/Duties: Regulatory (34%): *Develop and write Investigational Device Exemption (IDE) and Institutional Review Board (IRB) protocols for clinical trials of neurostimulation therapies, primarily for small-scale Early Feasibility pilots. *Supervise and train coordinators and regulatory staff in maintenance of necessary regulatory documentation, including but not limited to IRB and FDA reports/filings, electronic regulatory binders, and study report forms. *Maintain awareness of and update study practices to reflect ongoing developments in regulatory guidance related to neurotechnologies. Administrative/Financial (33%): *Develop, maintain, and track study budgets and associated documents, including budgets associated with grant submissions. *Maintain liaison and strong working relationships with study financial sponsors, device manufacturers, representatives of regulatory bodies, data analytic staff, and University administrators. *Coordinate high-level or mission-critical aspects of clinical studies, such as study device implantation, storage and proper handling of investigational product, data safety and monitoring board liaison, and harmonization of research procedures across studies. *Evaluate, hire, onboard, and generally supervise study staff across the clinical portfolio. The number of direct reports may vary from 2 to 10 depending on study status. *When appropriate, represent the studies in key meetings, e.g. national scientific meetings or cross-institutional harmonization meetings. Clinical/Scientific (33%): *Perform a limited set of advanced study procedures (e.g., adjustment of implantable neurostimulator parameters) under physician supervision. *Supervise and train clinical research coordinators and technicians in collecting standard rating scales and assessments. This will include quality control review of collected data. *Contribute to and draft publication-quality reports of study progress and outcomes. This will include both textual and graphical design, with writing to communicate to audiences across a wide range of education and sophistication. *Develop and maintain study scientific procedures in consultation with domain experts. This will include dev lopment of study proposals to funding bodies and sponsors. *Review ongoing study outcomes and monitoring data and recommend changes to study design as needed to achieve scientific goals. *Learn and maintain awareness of the scientific and clinical literature related to brain stimulation for neurocognitive illnesses, sufficient to develop and describe the scientific rationale underlying study designs. Qualifications Required Qualifications: *Advanced degree with at least four years of experience. The degree needs to be a clinical degree permitting performance of low-risk study procedures under physician supervision. A wide range of degrees, including nursing, psychology, social work, or medicine may qualify. *The years of experience requirement above should include at least 2 years of prior experience in a research setting. This does not need to be academic. *In good ethical and professional standing sufficient to participate as an investigator on Federally funded research studies. Preferred Qualifications: *Doctoral-level clinical degree *Prior experience in clinical practice or evaluation in mental disorders *Prior experience developing, leading, and/or publishing clinical research *Prior experience in developing funding proposals for scientific or clinical studies, particularly proposals to the National Institutes of Health *Prior experience in independently developing regulatory documents for clinical studies *Prior experience in neurostimulation (not necessarily brain stimulation) and/or medical device evaluation About the Department The Department of Psychiatry and Behavioral Sciences consists of an outstanding team of researchers, clinicians, and educators who provide world-class expertise in psychiatric illness, treatment, scholarship, and scientific discovery. Our mission is to: Create and disseminate new knowledge in the science of mental health Provide effective and innovative clinical care programs to alleviate the suffering of mental illness Train the next generation of experts who will be leaders in Minnesota and beyond Engage in compassionate and vigorous outreach and advocacy on issues relevant to psychiatric illness, treatment, and research 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... 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.