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Job #02989

About our client Our client is a leading pharmaceutical company headquartered in California that is focused on the development and commercialization of various ophthalmology disease therapeutics. The company has marketed products, an experienced management team and an empowering corporate culture that is focused on the professional development of its employees; this is a great opportunity for the right candidate! Position Location Senior Clinical Research Associate Irvine, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Recruit and select clinical sites 2) Develop Investigator database 3) Conduct and report site-qualification visit 4) Oversee training at clinical sites 5) Create training materials as well conduct and report site-initiation visits 6) Manage clinical sites 7) Conduct and report site interim monitoring and closeout visits 8) Answer sites' study-related questions and assist sites with Data Clarification Form (DCF) responses 9) Oversee and manage contract CRAs 10) Create site assignments 11) Conduct study and SOP training 12) Create monitoring plans 13) Facilitate and provide leadership to CRA team meeting 14) Review site visit reports 15) Work with Clinical Research Assistant for completing initial essential documents, developing regulatory binder contents and verifying documents at clinical sites (matching in-house files) 16) Assist the Clinical Research Manager with developing the Case Report Forms and Case Report Form Guidelines Requirements 1) BS 2) 5 – 8 years of CRA monitoring experience 3) Experience in managing CRAs 4) Willingness to travel, both domestically and internationally (40 – 60% approximately)