This position is part of a human clinical research program in the Adolescent Brain Function Lab focused on the use of neuromodulation and neuroimaging to study depression and suicidal behavior in adolescents. Anticipated future research includes (but is not limited to) various non-invasive brain stimulation technologies such as transcranial magnetic stimulation (TMS), neuroimaging, and electroencephalography (EEG).
Monitor implementation, management, coordination and documentation of all study activities in accordance with GCP, federal regulations and university policies. Ensure that components of the project are completed in an ethically and scientifically rigorous and timely manner. Ensure that lab personnel/volunteers are compliant with safety regulations and that lab-specific protocols are established and followed. Continuously update safety records and procedures. Provide administrative support to initiate new clinical studies, including assisting with preparation of grant applications and IRB submissions. Responsibilities also include acquiring internal approvals, budget negotiations, documentation, and regulation management.
The distribution of effort will change over time. It is anticipated that much of the first several months’ efforts will consist of Lab Management/Support. As regulatory steps are completed and enrollment of participants begins, a greater proportion of effort will be related to Protocol/Study Management.
Lab Management/Support - 50%
Act as a lead/mentor/trainer on primary study protocol and within the research team for other active studies
Support the supervision of undergraduate/graduate student volunteers (as needed)
Assist in the analysis of data and preparation of progress reports, presentations and manuscripts
Support the development of new grants and protocols (as needed)
Database development and management
Protocol/Study Management - 50%
Support the day-to-day management of research protocols under the general direction and oversight of the PI
Maintain working knowledge of assigned protocol
Work both independently and within a team structure on study tasks, including but not limited to:
Recruitment of study participants
Maintaining a working knowledge of patient eligibility and protocol specific requirements
Telephone and in-person screening per protocol-specific guidelines
Study visit scheduling and logistical support
Informed consent process
Administration of clinical assessments
Review of clinical data with PI or designated co-investigator
Administration of computerized behavioral assessments
Administration of transcranial magnetic stimulation (TMS) testing (extensive training will be provided)
Assisting with functional magnetic resonance imaging (fMRI) scans
Completion of case report forms and responding to data queries
Completion of adverse event (AE) logs and other study documentation
Completion of required reports/forms for any serious adverse events (SAEs) and notification of appropriate departments / regulatory bodies per requirements
Data management (collection and entry into electronic database, resolving queries/discrepancies)
Regulatory management (IRB, AE reporting, etc.), participant tracking, and general office paperwork and organization
Conducting financial, personnel, and administrative transactions (e.g., study participant payments and supply purchasing)
Special Notice for COVID-19 Hiring
The University of Minnesota has suspended hiring for positions that are not deemed critical to the University's mission and operations. At this time we are accepting applications for this position; however, hiring will not proceed until the hiring freeze is lifted. Thank you for your continued interest in working at the University of Minnesota.
All required qualifications must be documented on application materials.
Must have BA/BS in a science or health related field plus 2 years of work experience in research coordination; or a combination of related education and work experience in research coordination totaling 6 years
Proficiency with Microsoft Office software and comfortable with data capture systems such as RedCap
Experience supporting the coordination of clinical research
General knowledge of GCP and federal regulations as a whole
Availability to work a flexible schedule based on study and patient needs
Demonstrated ability to work independently, make decisions, problem solve, and prioritize
Excellent verbal and written communication skills
Experience with mentoring, training, or as a team lead
Experience in use of clinical assessment tools (structured and semi-structured interviews, clinical rating scales) in human studies
Experience in clinical research with children, adolescents, and young adults
Experience in use of computerized experimental behavioral tasks
Proficiency in FDA regulations surrounding the protection of human subjects and Title 21 CFR 812 that pertains to IDE projects
Assuming the availability of funds, this individual should have an interest in preparing for Certification as a Clinical Research Coordinator (e.g., SoCRA or ACRP)
Internal Number: 334963
About University of Minnesota, Twin Cities
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.