Clinical Research Associate at LS Solutions Alameda, CA

Job Title Clinical Research Associate Location Alameda, CA 94502 Duration 6 months with possible extension Travel Requirements 20-35% anywhere in USA as required. Job Description Member of the clinical team responsible for conducting Phase I-IV single or multi-center studies according to Federal Regulations and ICH guidelines. Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions. Responsible for writing basic study protocols, monitoring or overseeing monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification of data, and completion of study summary. 3-5 years experience level. Responsibilities Must have "Clinical Research Monitoring" experience. Perform study site visits: qualification visit, introduction visit, interim monitoring visits and close-out visits. Generate monitor reports and track resolution of any items that need attention. Monitor compliance to ICH guidelines, study protocol GCP (good clinical practice), Federal regulations, and other regulations. Monitor study documents including Trial Master Files. Perform review of clinical data study listing. Report to management and escalate any items needed. Account for devices during study. Prefer medical device background but will accept Pharma. Skills Monitoring experience. Great attention to detail and good organizational skills. Experience with EDC (electronic data capture) or Electronic Master Files. Employment Type Contractor Salary $50.00 - $55.00 per hour #J-18808-Ljbffr Selecto Vinos