Job Duties/Responsibilities: 1) Initiate new Alzheimer’s disease clinical studies, coordinate the enrollment of eligible patients, manage and coordinate research subject's participation, perform patient evaluations, extract and report quality patient data and samples, and respond to data queries. (30%)
2) Responsible for interpretation of, application of, and compliance with Federal Regulations, Good Clinical Practice (GCP), and University and Clinical Partner policies as it relates to assigned research protocols (20%)
3) Design and provide training concerning protocol and study procedures; primary responsibility for interpretation and implementation of the study protocol, procedures and definitions for the study team (10%)
4) Ensure accurate methods and procedures are used in labeling blood and cerebrospinal fluid sample tubes, centrifuging, pipetting, recording and transferring to frozen storage. (10%)
5) Act as information resource to University faculty and staff for protocol specific queries, including availability of trials, enrollment requirements, specimens needed, etc. (10%)
6) Communication with the IRB, SPA, sponsoring agencies, principal investigator(s), other service providers, subjects, families, and research team members. (10%)
7) Ensure timely and accurate data and regulatory (FDA and IRB) submissions; engage with providers and investigators to ensure adequate source documentation is available; accurate interpretation and recording of data; maintenance of subject research charts. (10%)
All required qualifications must be documented on application materials.
Required Qualifications: -BA/BS with at least 2 years of experience or a combination of related education and work experience to equal 6 years -Demonstrated interest in Alzheimer’s disease research -Ability to follow strict research protocols with utmost ethical standards. -Demonstrated knowledge of informed consent process and adverse event reporting. -Experience in the preparation of IRB applications and study-related documentation. -Experience interviewing and documenting study data appropriately. -Experience with Office Suite, Google Apps, and web-based systems for tracking activities, calendaring, and retrieving/updating information. -Demonstrated excellent communication skills; verbal and written
Preferred Qualifications: -Familiarity with clinical research at the University of Minnesota, University of Minnesota Medical Center Fairview hospital and clinics, and Veterans Administration Health Care System -EPIC familiarity. -Medical terminology knowledge. -Background in neurosciences. -Certification as a Clinical Research Coordinator, or qualified to sit for the SOCRA certification exam
Internal Number: 329136
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.