Clinical Research Lead - Psychiatric Brain Stimulation (Research Support Manager2)
Company: University of Minnesota
Location: Saint Paul
Posted on: April 16, 2024
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Job Description:
Apply for JobJob ID359403
LocationTwin Cities
Job FamilyResearch-Support
Full/Part TimeFull-Time
Regular/TemporaryRegular
Job Code9354S2
Employee ClassAcad Prof and Admin
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About the Job
The Translational Neural Engineering Laboratory () 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.
Qualifications
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
About the Department
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:
Benefits
Working at the UniversityAt 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:
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 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 ..This position will remain open until filled.To
request an accommodation during the application process, please
e-mail or call .
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 of a background check. Our presumption is that
prospective employees are eligible to work here. Criminal
convictions do not automatically disqualify finalists from
employment.
About the U of M
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.At the University of Minnesota, we are proud to be
recognized by the Star Tribune as a Top Workplace for 2021, as well
as by Forbes as Best Employers for Women and one of America's Best
Employers (2015, 2018, 2019, 2023), Best Employer for Diversity
(2019, 2020), Best Employer for New Grads (2018, 2019), and Best
Employer by State (2019, 2022).
Keywords: University of Minnesota, Maple Grove , Clinical Research Lead - Psychiatric Brain Stimulation (Research Support Manager2), Healthcare , Saint Paul, Minnesota
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