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

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 âœresponsiveâ or âœclosed loopâ 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