Research Professional 2

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). 

Job Duties/Responsibilities:

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
  • Visit implementation:
    • 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)