Job Duties/Responsibilities: The research coordinator will be assigned to the Muscular Dystrophy (MD) Center within the Department of Neurology to be a key team member for clinical research studies in adults and children with neurological diseases. The research coordinator will organize various aspects of clinical research studies, including clinical trials, from start-up to close-out in accordance with Good Clinical Practice (GCP), other regulations, and University policies. Troubleshooting and independent problem solving skills will be important. The clinical research studies are expected to be at moderate risk levels regarding potential adverse events. Guidance and training specific to the role will be provided. Mentorship and support for career development will be provided by multiple leadership figures in the department and the center.
60% - Study Coordination. Responsibilities will include interpreting study protocols; recruiting participants; coordinating communications and study visits; collecting, processing, and shipping specimens for research or laboratory testing; assessing study-related needs, providing input to facilitate implementation, performing protocol-required tests and procedures, maintaining accurate and complete study records, maintaining a safe physical environment for research participants, and acting as a liaison among Principal Investigators, University departments, outside sponsors, clinical partners, and collaborators.
35% - IRB and regulatory duties. Responsibilities will include drafting and editing investigator initiated protocols and regulatory paperwork; preparing and submitting IRB applications, modifications, and other internal documents; creating, collecting, and maintaining regulatory documents for clinical trials; facilitating and coordinating monitoring visits; maintaining regulatory compliance; communicating with the FDA for interventional studies.
5% - other duties as assigned.
All required qualifications must be documented on application materials
Required Qualifications: • BA/BS in a scientific, medical, or public health-related field and at least 2 years experience in a clinical or clinical research setting or a combination of related educations and work experience to equal 6 years • Ability to work independently, make decisions, problem solve and triage tasks among multiple clinical research projects, each with a different set of team members and leadership • Demonstrated organization skills with excellent attention to detail • Excellent verbal and written communication skills
Preferred Qualifications: • Additional years of work experience in clinical or clinical research setting • Experience working with children and adults in a research setting • Experience with an electronic medical record system, especially EPIC • Experience with regulatory matters, especially institutional review boards (IRBs) • Familiarity with the University of Minnesota, University of Minnesota Medical Center, Fairview, MHealth hospitals and clinics
Internal Number: 339708
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.