Clinical research professional - research mental research professional
Location
Minnesota | United States
Job description
Job ID: 359736
About the Job The Translational NeuroEngineering Laboratory (TNEL) in the
University of Minnesota Department of Psychiatry is seeking a clinical research professional (Research Professional 2) to assist with
management of human neuroscience studies and clinical trials of new treatments for severe mental illness. Specifically, this position will
focus on studies of deep brain stimulation (DBS) and related technologies for depression, obsessive-compulsive disorder, and possibly other
conditions. It involves a mixture of direct work with patients for data collection and study coordination/administration. There are usually
multiple studies ongoing in the lab, with funding from both industry and Federal government. Some of the studies involve FDA interactions
for Investigational Device Exemptions.
Duties/Responsibilities:
* (40%) Accurate and timely maintenance of all study and
regulatory documentation for multiple studies, including compliance with applicable sponsor, institutional, state, and Federal policies
*
(20%) Human research participant interactions, including administering standardized neuro-psychological assessments and performing study
data collection procedures. Data collection will involve the use of specialized equipment and software, some of which may be investigational
or custom-built for the study.
* (10%) Preparation of study materials, including consent forms, standard operating procedures, and
standardized protocols for submission to regulatory bodies
* (10%) Curation, preparation, and maintenance of human clinical research
data
* (5%) Development of procedures for reaching and recruiting study populations, including Internet-based and community outreach
strategies
* (5%) Serving as liaison to other UMN research teams and other study sites to maintain fidelity of research protocols.
*
(10%) Other responsibilities that are commonly part of a clinical research coordinator's duties, such as:
o Identify potential risks and
take steps to promote subject safety.
o Identify interdisciplinary and facility resource needs and facilitate implementation.
o
Prioritize protocol needs, determine priorities, identify potential risks and implement a plan to address risks.
o Collaborate with other
disciplines involved in the research process
o Assist with development of clinical research protocol documentation
o Demonstrate
effective and efficient communication with study sponsors, monitors, department and University staff
o Maintain accurate and complete
study records, supplies, and time keeping tools.
o Maintain a safe physical environment for the research subject(s).
o Complete and
maintain essential, source, and regulatory documents
o Contribute to the efficiency and effectiveness of the research process by offering
suggestions and participating as an active member of the research team
o Participate in production of research publications or
presentation of research data
o Report work time on an electronic time card
o Update Subject Tracking Forms in the organization's
business system.
o Perform research procedures for the collection of meaningful research data.
o In accordance with GCP and protocol,
provide services, assessments, or interventions
o Identify the appropriate personnel to perform direct and indirect research activities
based on needs, condition, and potential for risk/harm, by evaluating the complexity of the activity and predictability of the outcome.
o
Continually evaluate the successful approach to protocol implementation in accordance with GCPs.
o Evaluate compliance to protocol and
systematically and continuously evaluate subject response to interventions, expected outcomes, and possible adverse reactions.
o Manage
subject participation in research protocol:
o Recruit potential subjects
o Participate in protecting the rights of the research
subject via execution of informed consent and compliance with HIPAA requirements
o Determine subject eligibility and maintain compliance
with protocol eligibility requirements.
o Collect, and ship specimens for research, laboratory, or clinical testing as required, often in
repetitive and concise fashion so as to maintain integrity across all subject visits.
o Monitor subject responses to protocol defined
treatments/interventions, and schedule required visits and tests.
o Evaluate laboratory and other findings to determine the presence of
expected and unexpected subject reactions or outcomes
Qualifications Required Qualifications:
* BA/BS with
at least 2 years of experience or a combination of related education and work experience to equal 6 years.
* Familiarity with clinical
research practices, Good Clinical Practice guidelines, and applicable regulations
* Strong attention to detail, conscientiousness, and
organizational skills
* Ability to work in a multidisciplinary environment, with colleagues from a variety of skills and backgrounds
*
Ability to maintain a professional demeanor when working with research participants who may have significant emotional disturbances
*
Flexibility to conduct study procedures across a range of locations, including operating suites, inpatient care floors, clinics, and
research laboratories
* A combination of work and educational experience suitable to qualify for eligibility for the ACRP Clinical
Research Coordinator certification program ().
* Strong verbal and written communication skills in
English
* Ability and willingness to obtain and document immunizations required for work in clinical environments (e.g., measles,
influenza, hepatitis B, negative tuberculosis testing).
Preferred Qualifications:
* Documented ability in scientific/technical
writing, e.g. past contributions to published research papers or other scholarly products
* Training or experience in statistical
analysis of scientific data
* Additional training beyond the minimum requirements, or completion of Clinical Research Coordination
certification
* Prior education or experience in neuroscience, clinical treatment of mental illness, and/or medical device research
*
Experience with stakeholder or other forms of public engagement
* Specific experience with software in use in our clinics and laboratory
(EPIC, REDCap, R)
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:
- 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 .
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 sessions of counseling at no cost
Please visit the Office of Human Resources website 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
[email protected] 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 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).
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