Shawna Cote Email & Phone Number

Clinical Research professional for over 30 years including 10 years of CRO onsite monitoring experience and 24 years in neuroscience focused clinical trials monitoring and execution. Quality Assurance Specialist | Clinical Research AssociateEmail: shawnacote@aol.comSenior Clinical Research Associate and Quality Assurance Specialist excelling in research site FDA inspection / sponsor audit preparation and CAPA resolution. Well-versed in clinical trial areas such as site selection and feasibility, study start-up, vendor management, SOP creation and dissemination, learning management system implementation, site management, monitoring activities, and quality assurance for Phases I through IV clinical trials.CORE COMPETENCIES:Inspection preparationCAPA resolutionQuality AssuranceSOP creationPrestudy, Initiation, Routine and Closeout Monitor visitsRegulatory File reviewACCOMPLISHMENTS:Oversaw quality processes and procedures for network of nineteen research sitesLead the Standard Operating Procedures (SOP) committee to assess and evaluate current SOPs and update as neededWorked to harmonize quality programs and best practices network of nineteen research sitesCreated and implemented vendor management programContact me at (925) 286-0526 or shawnacote@aol.com for Clinical Research Associate / Quality Assurance opportunities.