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Clinical Research Associate (CRA) - B




This position is NonExempt. Hours over 40 will be paid at Time and an Half. Member of the clinical team responsible for conducting Phase I-IVn single or multi center studies according to Federal Regulations and ICHn guidelines. Responsible for assisting senior staff in planning study nconduct, designing case report forms (CRFs), Contract Research nOrganization (CRO) selection and management, selection and training of ninvestigator sites, planning and running study meetings, evaluation, nselection and training of new study investigators and writing and nassembling submissions. Responsible for writing basic study protocols, nmonitoring or overseeing monitoring of investigational sites to ensure nprotocol adherence, assuring timely enrollment of patients and retrievaln of CRFs from study sites, processing CRFs including data cleanup and nclassification of data, and completion of study summary. 3-5 Years nExperience Level.Worksite Address675 North Field Drive, Lake Forest, IL 60045n nn General Commentsn ######### :41 PM - -: Start date asap. 3-5 years of clinical nmonitoring of devices for regulatory submission. Good working knowledge nof FDA regulations and GCP required. Experience as a research ncoordinator acceptable if experience is on studies for regulatory nsubmissions. Must have Bachelor's in Scientific area to be considered; nMedical Technologist or Laboratory Science degree is preferred. Local ncandidates preferable.     

Posted 13 days ago

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