The Anker lab, which studies biomarkers and digital therapeutic approaches for treating substance use disorders, has an exciting opportunity for a Research Coordinator.

Job Duties/Responsibilities:

1) Clinical Research Coordination (45%):
-Contribute to study start-up activities, including site initiation visits, OnCore set-up, document template, flow sheet creation, study staff training, and clinical in-services.
-Participant recruitment, screening, consent, enrollment, and necessary registrations.
-Perform study data collection and entry; collect enrollment and treatment data.
-Perform protocol procedures and data/specimen collection and processing.
-Coordinate/conduct quality control checks as related to study conduct.
-Coordinate study close-out activities.
-Assist in participant recruitment using recruitment dashboard and contribute to pilot testing and RCT phases.
-Perform study testing that includes administering behavioral assessments and collecting digital engagement metrics.

2) Regulatory Compliance and Support (25%):
-Responsible for the interpretation of, application of, and compliance with federal regulations, Good Clinical Practice (GCP), and University and Clinical Partner policies as they relate to assigned research protocols.
-Under the supervision of a Psychiatry Regulatory Specialist, create regulatory files for new studies;
-Complete IRB and other required review committee applications on assigned protocols;
-Draft study-related subject informed consent form documents according to Sponsor and University requirements;
-Draft study-related correspondence, including preparing FDA submissions, for study PI;
-Under the supervision of a Regulatory Specialist, create and maintain all required documents for assigned regulatory binders;
-Assist Pis and the Regulatory Specialist in preparation for audits/monitoring visits

3) Data Management (20%)
-Responsible for data management, collection, entry, and appropriate data storage for multiple projects.
-Create REDCap surveys, databases, and enter study data.
 

All required qualifications must be included in the application materials

Required Qualifications:

-BA/BS with at least 2 years of experience in clinical research or a combination of related education and work experience to equal 6 years
-Experience in the preparation of IRB applications geared explicitly toward digital health interventions.
-Working knowledge of regulations governing research activities (such as GCPs, FDA regulations, and ICH guidelines)
-Familiarity with Quality Management Systems.
-Experience with data management platforms such as REDCap.
-Demonstrates ability to initiate and process multiple projects simultaneously
-Experience with Office Suite, Google Apps, and web-based systems for tracking activities, calendaring, and retrieving/updating information.
-Possess attention to detail and excellent verbal and written communication skills.
-Organizational skills are a must.

Preferred Qualifications:
-Minimum of one (1) year experience in a clinical research setting in an academic health center.
-Certification as a clinical research professional with SoCRA or ACRP or willingness to obtain certification at the time of eligibility.
-Familiarity with mobile application data analytics.
-Proficient in data visualization tools and statistical software such as R or SPSS.

About University of Minnesota Twin Cities

The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.

Connections working at University of Minnesota Twin Cities