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Job #02407

About our client Our client is a privately held biopharmaceutical company headquartered in Silicon Valley that is dedicated to the development and commercialization of antibody-based therapeutics. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Senior Clinical Research Associate Silicon Valley, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Participate in planning of study implementation with managers 2) Review protocols to become familiar with details and communicate with study personnel to confirm/clarify protocol guidelines 3) Participate in protocol development and CRF design 4) Travel to study sites to evaluate eligibility and enlist investigators 5) Discuss details of study budgets with investigators and ensure that contracts are properly executed before initiation of studies 6) Prepare and present protocol and study-related presentations at investigator meetings 7) Travel to study sites on an ongoing basis to monitor progress 8) Collect, review and correct case report forms in accordance with study timelines 9) Monitor progress of enrollments and other benchmarks to assess ongoing progress Requirements 1) Bachelor’s degree in a scientific discipline 2) 5+ years of clinical trial experience in the pharmaceutical or biotech industry 3) 5+ years of field monitoring experience 4) Experience in monitoring clinical trials from qualification to closeout 5) International trial and CRO management experience 6) Strong knowledge and understanding of FDA regulations and GCPs 7) Exceptional communication skills 8) Willingness to travel