Clinical Research Lead - Psychiatric Brain Stimulation (Research Support Manager 2)

The Translational Neural Engineering Laboratory (http://www.tnelab.org) in the University of Minnesota Department of Psychiatry is seeking a clinical research lead to act as high-level orchestrator of 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. You will be working at a high level of independence, in many cases substituting for the laboratory principal investigator(s).

Responsibilities of this position will include:

Regulatory (33%):
*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 ensuring all regulatory requirements are met and documented for clinical trials, 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.
*Manage study and portfolio staffing by forecasting staffing needs, hiring and training staff, and managing workloads and project timelines.
*Serve as a representative on various teams and committees making decisions and recommendations on behalf of the laboratory. These will include national scientific meetings or cross-institutional harmonization meetings.

Clinical/Scientific (33%):
*Develop strategic plan for initiation and execution of clinical trials. This will include funding, regulatory, and recruitment goals, with appreciation of the complex interlock between these.
*Perform a limited set of advanced study procedures (e.g., adjustment of implantable neurostimulator parameters) under physician supervision.
*Collaborate with investigators, project managers, and other study staff, particularly clinical research coordinators and technicians in collecting standard rating scales and assessments.
*Develop and maintain standard operating procedures, followed by quality control review of collected data.
*Recruit and successfully activate sites for studies, including meeting with site personnel on behalf of the PI.
*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 development 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.

Required Qualifications:

Requires BA/BS with at least 8 years of experience or advanced degree with 6 years of experience and prior oversight of a small department or cross-disciplinary team.

*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.
*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

The Department of Psychiatry & 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 and promote mental resilience
• Train the next generation of interprofessional 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

You can find more information on our website at https://med.umn.edu/psychiatry.

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.

Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will have 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.

Questions about responsibilities, scope of work, or other aspects of this position are welcomed by the laboratory PI, Dr. Alik Widge, and can be directed to awidge@umn.edu ..

This position will remain open until filled.

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.

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