Clinical Research Associate Ii, University Of Michigan Emergency Medicine Nett Trials
Work on all aspects of RAMPART, SHINE, POINT, ESETT AND ATACH trials within the University of Michigan Emergency Medicine Neurological Emergency Treatments Trials (NETT). Work on trials as it relates to documentation, the processing of regulatory documents, monitoring multiple study databases to track Missing, Expired, and Rejected regulatory documents, communicating with study site Program Managers (PM) and Primary Study Coordinators (PSC). Audit completed study medical record data to ensure all patient identifiable data has been redacted, all required elements of the chart are present and in the prescribed order. Assist Site Managers with tasks needed to get new study sites up and running. Monitor sites for study retraining needs when they haven't enrolled a study patient in 6 months. Monitor and reconcile site Delegation of Authority logs. Alert Site Manager when site documentation issues are increasing, investigate and intervene as necessary. Maintain database logs to track activity.