Clinical Research Coordinator - Research Professional

Position: Clinical Research Coordinator - Research Professional 2
About the Job

The Translational Neuro Engineering Laboratory (TNEL) in the University of Minnesota Department of Psychiatry is seeking a Clinical Research Coordinator (Research Professional
2) to assist with management of human neuroscience studies and clinical trials of new treatments for severe mental illness. This position will specifically focus on trials of non-invasive brain stimulation methods, including focused ultrasound and temporal interference stimulation. The target conditions include chronic pain, depression, obsessive-compulsive disorder, and possibly related conditions such as sensory sensitivities. There will also be involvement with our programs in deep brain stimulation (DBS) for depression and obsessive-compulsive disorder.

The role involves a mixture of direct work with patients for data collection and study coordination/administration. Some of the studies involve FDA interactions for Investigational Device Exemptions.

Job Duties /Responsibilities:

* (30%) Accurate and timely maintenance of all study and regulatory documentation for multiple studies, including compliance with applicable sponsor, institutional, state, and Federal policies
* (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
* (30%) 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.
* (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:

* Identify potential risks and take steps to promote subject safety.

* Identify interdisciplinary and facility resource needs and facilitate implementation.

* Prioritize protocol needs, determine priorities, identify potential risks and implement a plan to address risks.

* Collaborate with other disciplines involved in the research process

* Assist with development of clinical research protocol documentation

* Demonstrate effective and efficient communication with study sponsors, monitors, department and University staff

* Maintain accurate and complete study records, supplies, and time keeping tools.

* Maintain a safe physical environment for the research subject(s).

* Complete and maintain essential, source, and regulatory documents

* Contribute to the efficiency and effectiveness of the research process by offering suggestions and participating as an active member of the research team

* Participate in production of research publications or presentation of research data

* Report work time on an electronic time card

* Update Subject Tracking Forms in the organization's business system.

* Perform research procedures for the collection of meaningful research data.

* In accordance with GCP and protocol, provide services, assessments, or interventions

* 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.

* Continually evaluate the successful approach to protocol implementation in accordance with GCPs.

* Evaluate compliance to protocol and systematically and continuously evaluate subject response to interventions, expected outcomes, and possible adverse reactions.

* Manage subject participation in research protocol:

* Recruit potential subjects

* Participate in protecting the rights of the research subject via execution of informed consent and compliance with HIPAA requirements

* Determine subject eligibility and maintain compliance with protocol eligibility requirements.

* 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.

* Monitor subject responses to protocol defined treatments/interventions, and schedule required visits and tests.

* Evaluate laboratory and other findings to determine the presence of expected and unexpected subject reactions or outcomes

Qualifications

Required Qualifications:

* BA/BS degree plus at least two years of relevant experience, or a combination of education and relevant work experience to equal at least six 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…