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Job #02851

About our client Our client is a privately held biopharmaceutical company focused on auditory drug development. This is an ideal opportunity to become involved in cutting-edge technology in the biotechnology industry. Position Location Senior Clinical Research Associate Seattle, Washington Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop, execute and manage clinical studies including writing of study protocols, ICFs, CRFs, study reports and summaries as well as other study-related documents 2) Evaluate and recommend selection of investigators/study sites (independently) 3) Participate in identifying potential sites 4) Ensure collection of patient data that is accurate, complete and conforms to project data standards and protocol requirements 5) Monitor and closeout clinical studies, ensuring adherence to protocol, accurate data collection on CRFs via comprehensive source document verification and device accountability 6) Ensure the collection and updation of all essential documents as is defined by FDA regulations, the client, SOPs and general industry standards 7) Develop solutions for logistical and operational issues that arise during trials execution and communicate these in a timely fashion to investigators, Coordinator and staff 8) Identify and prepare written reports for product complaints, serious or unexpected adverse events 9) Attend relevant scientific and/or medical meetings 10) Maintain a high level of professional expertise through familiarity with clinical literature 11) Work with clinical data analysts and biostatisticians to maintain, analyze and report outcomes’ data 12) Prepare accurate and timely study reports and disseminate outcome results to clinical investigators, internal clinical personnel and external groups 13) Support company goals and objectives, policies and procedures, GCPs as well as FDA and other notifying bodies’ regulations Requirements 1) Bachelor’s degree in Life Sciences 2) 5+ years of progressive experience as a CRA 3) Field monitoring and recent in-house experience in working directly for a small biotechnology company 4) Proven job stability as a full-time employee (not multiple contract positions) 5) Excellent communication and presentation skills