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.