The Translational NeuroEngineering Laboratory (TNEL) in the University of Minnesota Department of Psychiatry is seeking a clinical research professional 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:
â¢(40%) Accurate and timely maintenance of all study and regulatory documentation for multiple studies, including compliance with applicable sponsor, institutional, state, and Federal policies
â¢(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.
â¢(10%) Preparation of study materials, including consent forms, standard operating procedures, and standardized protocols for submission to regulatory bodies
â¢(10%) Curation, preparation, and maintenance of human clinical research data
â¢(5%) Development of procedures for reaching and recruiting study populations, including Internet-based and community outreach strategies
â¢(5%) Serving as liaison to other UMN research teams and other study sites to maintain fidelity of research protocols.
â¢(10%) Other responsibilities that are commonly part of a clinical research coordinatorâ™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

 

All required qualifications must be documented on application materials

Required Qualifications:

â¢BA/BS with at least 2 years of experience or a combination of related education and work experience to equal 6 years. 
â¢Familiarity with clinical research practices, Good Clinical Practice guidelines, and applicable regulations
â¢Strong attention to detail, conscientiousness, and organizational skills
â¢Ability to work in a multidisciplinary environment, with colleagues from a variety of skills and backgrounds
â¢Ability to maintain a professional demeanor when working with research participants who may have significant emotional disturbances
â¢Flexibility to conduct study procedures across a range of locations, including operating suites, inpatient care floors, clinics, and research laboratories
â¢A combination of work and educational experience suitable to qualify for eligibility for the ACRP Clinical Research Coordinator certification program (https://www.acrpnet.org/certifications/crc-certification/). 
â¢Strong verbal and written communication skills in English
â¢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: 

â¢Documented ability in scientific/technical writing, e.g. past contributions to published research papers or other scholarly products
â¢Training or experience in statistical analysis of scientific data
â¢Additional training beyond the minimum requirements, or completion of Clinical Research Coordination certification
â¢Prior education or experience in neuroscience, clinical treatment of mental illness, and/or medical device research
â¢Experience with stakeholder or other forms of public engagement
â¢Specific experience with software in use in our clinics and laboratory (EPIC, REDCap, R)

About University of Minnesota Twin Cities

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