CCRA (Certified Clinical Research Associate), CCRC (Certified Clinical Research Coordinator), CCRP (Certified Clinical Research Professional)
4 Year Degree
This Project Coordinator position will support the EPINET project within the Vinogradov Lab. This project is part of a national NIMH initiative which aims to create a network of early psychosis intervention treatment centers offering specialty care to individuals with a recent onset psychotic illness. This study has two primary components. In the first, we are examining longitudinal measurement based care, comprised of self-report assessments and remote interviews conducted through teleconferencing applications; the data from these assessments will generate a personalized report which will be presented to the participant by a clinical team member. The second component is a 12-week mobile intervention of cognitive training and motivational enhancement using mobile applications, which the participant will complete at home. This project will be a multi-site study with four recruiting locations: Fairview Riverside, HCMC, Saint Louis Park, and Duluth. The incumbent in this position will be the Project Coordinator for this study and will supervise the Study Coordinators at each of the recruiting sites.
Primary job duties will include providing supervision and coaching to the Study Coordinators, coordinating team meetings, preparing submissions to IRB and NIH, and ensuring compliance to the protocol, local and federal regulations, and terms of the grant. The applicant must be able to work independently at locations off campus (independent transportation is strongly encouraged). Further, the candidate must have good general knowledge of GCP and federal regulations for clinical research. The applicant must also have excellent organizational skills and attention to detail. Certification for clinical research administration is strongly encouraged and may be pursued in this role.
About the Job
Staff Supervision (40%):
Oversee study coordination and protocol compliance
Establish work flows and guidance documents for staff to follow for appointments, regulatory documentation, etc.
Meet regularly with Study Coordinators to provide support, guidance, and feedback
Delegate job assignments to employees, establish deadlines
Coordinate efforts of multiple study teams, including providing weekly reports and facilitating progress discussions with team members
Provide regular staff updates to supervisor
Conduct annual performance evaluations; deliver annual performance feedback to the PI
Participate in interviewing and hiring of laboratory personnel
Assist with training and orientation of new hires
Oversee volunteers within the project
Provide resources and access to services/platforms for team members based on their job requirements
Serve as support for study coordinators during appointments, as needed
Other duties as assigned
Project Coordination (50%):
Ensure adherence to federal, state, University and departmental policies and procedures
Oversee regulatory documents such as enrollment logs, training logs, adverse event logs, etc., as required by FDA regulations
Prepare materials for submission to single IRB and local IRBs, including developing/editing protocols, consent/assent forms, recruitment materials, etc.
Communicate with Regulatory Specialists and the study team to provide complete responses to stipulations, continuing reviews, amendments to protocols
Inform the PI and Co-I of adverse events and protocol deviations. Report events as required to the sIRB and local IRB
Coordinate with internal monitors and regulatory specialists to conduct regular monitoring visits. Prepare files for review. Submit reports as required per local policies.
Comply to the terms of the grant for reporting of enrollment numbers and completing regular data uploads to NIMH Data Archive
Oversee data management tasks and regularly review databases for quality and accuracy
Assist with purchasing supplies, establishing relationships with vendors, budget management
Coordinate team meetings. Provide regular updates to lab meeting and multi-site team meetings
Other tasks as assigned
Lab support tasks (10%):
Assist the PI with literature review, manuscripts, or other tasks as needed
Prepare materials for presentations, publications, and grants, such as figures or tables
Present materials at conferences
Assist in writing of manuscripts and publications
Conduct statistical analyses using SPSS, R, or other statistical software as needed
Other tasks as assigned
About the U of M
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.
About the Department
To learn more about the Department of Psychiatry and Behavioral Sciences, please visit: https://med.umn.edu/psychiatry
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.
Background Check Information
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.
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
General experience with mentoring, training, or as a team lead
MA/MS in Neuroscience, Psychology, Public Health, Clinical Research, or related field
Clinical research certification (e.g., SOCRA, ACRP)
Total combined education and experience of 6 years, at least 2 of which is in a research setting
Clinical or research experience with individuals experiencing a psychotic illness
Previous experience working as a supervisor or manager
Internal Number: 333430
About University of Minnesota Department of Psychiatry and Behavioral Sciences
About the Department:
The University of Minnesota Department of Psychiatry and Behavioral Sciences consists of an outstanding team of researchers, clinicians, and educators who provide world-class expertise in psychiatric illness, treatment, scholarship, and scientific discovery. We consist of 66 faculty, 15 specialty clinics, with 168 active studies. Our mission is to create and disseminate new knowledge in the science of mental health, to provide effective and innovative clinical care programs to alleviate the suffering of mental illness, to train the next generation of experts who will be leaders in Minnesota and beyond, and to engage in compassionate and vigorous outreach and advocacy on issues relevant to psychiatric illness, treatment, and research. To learn more about our Department, please visit https://med.umn.edu/psychiatry/about
Information about benefits of working at the University of Minnesota and University of Minnesota Physicians can be found at: https://humanresources.umn.edu/benefits & https://mphysicians.org/careers.
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.
University of Minnesota is based in the beautiful Minneapolis-St. Paul metropolitan area, ranked as the #6 best place to live in America by U.S. News & World Report in 2019. For more information about the vibrant culture, community, and recreation that Minneapolis-St. Paul has to offer, please click on the links below.
Greater Minneapolis - St. Paul Metropolitan: https://www.greatermsp.org/living-here/living-here/
U.S. News & World Report Ranking: https://realestate.usnews.com/places/minnesota/minneapolis-st-paul
Explore Minnesota: http://www.exploreminnesota.com/
Minnesota Department of Education: http://www.education.state.mn.us/