Rsch Pro -Rsch Coord-Gnrlst

About the Job

The Center for Developmental Neuro Imaging (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

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

All required qualifications must be documented on application materials

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

Pay Range: $62,000 - $90,000/year

Time Appointment: 100% Appointment

Position Type: Civil-Service & Non-Faculty Labor Represented Staff

The University offers a comprehensive benefits package that includes:

• Competitive wages, paid holidays, and generous time off
• Continuous learning opportunities through professional training and degree-seeking programs…