About the Job

The Center for Developmental NeuroImaging (CDNI) is seeking a Research Professional III to coordinate clinical trials, protocol and regulatory documentation, and interface with funding agencies for multiple principal investigators. A successful applicant has prior experience managing clinical trials, including protocol development and management, is detail-oriented, works effectively with a team, and communicates clearly in a collaborative environment with a diverse range of research tasks and disciplines. This position is not eligible for remote work.

The CDNI is housed at the Masonic Institute for the Developing Brain at the University of Minnesota. Our work focuses on advancing the understanding of brain development in health and disease. We are an interdisciplinary team of researchers trying to:

Understand basic principles of brain functioning across development (i.e. figure out how the brain works)
Learn about how neuropsychiatric and other brain-based disorders develop and progress over time
Contribute to the prevention and treatment of brain-based disorders
Engage underrepresented communities in all aspects of academic medicine and research

To learn more about CDNI and current research studies, please visit the website: https://innovation.umn.edu/developmental-cognition-and-neuroimaging-lab/

Please upload a cover letter and CV/resume. Your application will not be considered until all components of the application are complete. Review of applications is ongoing, and the position will remain open until the posting is removed.

Responsibilities:

Regulatory Development and Maintenance (60%)

Supervise and train coordinators, regulatory staff and principal investigators in maintenance of necessary regulatory documentation, including but not limited to IRB, NIH, and FDA reports/filings, electronic regulatory binders, and study report forms.
Accurate and timely maintenance of all study and regulatory documentation for multiple studies, including compliance with applicable sponsor, institutional, state, and Federal policies
Develop and write Investigational Device Exemption (IDE) and Institutional Review Board (IRB) protocols for clinical trials of neuromodulation therapies.
Complete and maintain essential, source, and regulatory documents
Demonstrate effective and efficient communication with study sponsors, monitors, department and University staff
Document best practices for various research activities to ensure they are carried out in a standardized manner

Clinical Data Collection and Coordination (30%)

Utilize internal and external registries to identify potential participants for research studies
Conduct phone screens with participants to determine eligibility for the studies
Lead the scheduling and coordination of research visits involving MRI scans, biospecimen collection, and cognitive/behavioral tasks
Reliably enter study data into online databases
Maintain conformity with the established protocol, Good Clinical Practice, and University of Minnesota policies
Leads necessary study visits that align with variable participant schedules (early morning, late evening, and/or weekends)
Escalate progress, milestones and concerns to principal investigator(s) and management
Lead meetings with clinicians and effectively communicate concerns
Facilitate open communication between research participants and staff
Provide up-to-date tracking of study recruitment and enrollment efforts
Organize study materials for visits

Other Lab Duties (10%)

Attend mandatory center, lab and team meetings
Share feedback and assist other lab members when they are stuck on a project
Collegial conduct towards co-trainees, staff members and members of the research group
Adherence to all applicable University policies, procedures and regulations. All data, research records and materials and other intellectual property generated in University laboratories remain the property of the University

Qualifications

Required Qualifications:

BA/BS with at least four years of previous research experience or advanced degree with at least two years of relevant experience, or a combination of related education and work experience to equal at least eight years
Sufficient computer knowledge with Google suite and Microsoft office
Ability to multi-task without losing attention to detail
1 year of experience in clinical trial research, lab management, or direct study oversight

Preferred Qualifications:

Experience with research participants
Interest in neuroscience, psychology, neuroimaging and/or human development
Ability to delegate work to and support research assistants
Open to learn MRI data acquisition techniques
Excellent documentation/writing skills
Adobe Acrobat experience
Familiarity with HIPAA and GCP guidelines
Effectiveness in organizing tasks and setting priorities, verbal and digital communication with others, interacting constructively with faculty and staff, and the ability to be adaptable, creative, and a quick learner