Rsch Pro 3-Rsch Coord-Gnrlst

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

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; depending on education/qualifications/experience

Time Appointment: 100% Appointment

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

Please visit the Office of Human Resources website for more information regarding benefit eligibility.

The University offers a comprehensive benefits package that includes:

• 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 supported by the Regents Tuition Benefit Program
• Low-cost medical, dental, and pharmacy plans
• Healthcare and dependent care flexible spending accounts
• University HSA contributions
• Disability and employer-paid life insurance
• Employee wellbeing program
• Excellent retirement plans with employer contribution
• Public Service Loan Forgiveness (PSLF) opportunity
• Financial counseling services
• Employee Assistance Program with eight sessions of counseling at no cost

Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume.

Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section.

To request an accommodation during the application process, please e-mail employ@umn.edu or call (612) 624-8647.

The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds.

The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu

Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.

The University of Minnesota, Twin Cities (UMTC)

The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.

At the University of Minnesota, we are proud to be recognized by the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America's Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022).

The University of Minnesota Medical School

Committed to innovation and diversity, the Medical School educates physicians, scientists, and health professionals; generates knowledge and treatments; and cares for patients and communities with compassion and respect. We value excellence, inclusiveness, collaboration, and discovery.
The mission of the regional campus located in Duluth is to be a national leader in improving healthcare access and outcomes in rural Minnesota and American Indian/Alaska Native (AI/AN) communities. In partnership with CentraCare, the regional campus in St. Cloud offers a wide range of patient experiences throughout students' education in Greater Minnesota and prepares them to become exceptional clinicians and leaders for rural and immigrant populations.

Founded in 1888, the University of Minnesota Medical School has three campuses. A four-year MD program and the MD/PhD program are located on the Twin Cities campus in addition to MD programs at regional campuses in Duluth and St. Cloud.