Clinical Research Coordinator (Research Professional 2) - Part Time

About the Job

The Bronstein lab in the University of Minnesota Department of Psychiatry and Behavioral Sciences is seeking a part-time (20 hours per week) Clinical Research Coordinator (Research Professional 2) for a project which focuses on personalized, non-invasive neuromodulation to improve mental health outcomes.

Job Duties/Responsibilities:

Participant Facing – 70%:
•Lead recruitment efforts for the clinical study, including identification, recruitment, screening, and enrollment of study participants.
•Obtains informed consent from study participants.
•Collects and maintains participant and laboratory data.
•Under the direction of the PI or study manager, works directly with the study participants and families and serves as project liaison to other departments, healthcare units and clinics, outside organizations, and government agencies.

Regulatory – 15%:
•Identifies, reviews, and reports adverse events, protocol deviations, or other unanticipated problems appropriately.
•Contributes to study start-up activities, such as site initiation visits, document template creation and study staff training.
•Contributes to regulatory documentation for the clinical study, such as the Institutional Review Board application, revision, safety reports, adverse events, and yearly renewals.
•Maintains source documents.

Administrative – 15%:
•Coordinate various aspects of interventional/therapeutic clinical trials from protocol development through closeout in accordance with Good Clinical Practice (GCP), applicable regulations, and University policies.
•Collaborates with Principal Investigator (PI) and other team members to achieve project objectives, coordinating complex research procedures, multiple visits with complex schemas, and follow-up care.
•Participates in the build of clinical study and order sets and ensures orders are accessible by the clinical care teams as appropriate.
•Creates and maintains tools and documentation to track study metrics.
•Provides status updates to management.
•Participates in quality control and internal monitoring activities.
•Contributes to the development of research protocols, IND/IDE applications to the FDA, the production of research publications or presentation of research data.
•Writes sections of grant applications, abstracts/posters, and/or manuscripts.

Qualifications

All required qualifications must be included in the application materials

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.
•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 professional demeanor when working with research participants who may have significant emotional disturbances
•Flexibility to conduct study procedures across a range of locations, including MRI suites, inpatient care floors, clinics, and research laboratories
•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, SARS-CoV-2).

Preferred Qualifications:
•BA/BS in biomedical engineering, psychiatry, psychology, neuroscience, physiology
•Training or experience in clinical study recruitment
•Training in GCP and applicable regulations
•Training or experience in functional neuroimaging, especially magnetic resonance imaging

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