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Job #02829

About our client Our client is a leading biotech company headquartered in California that is focused on the development and commercialization of gene therapeutic solutions. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Clinical Research Associate II Richmond, California (Bay) Salary Highly competitive package, commensurate with experience Responsibilities 1) Assist with designing, planning and implementation of clinical research projects 2) Facilitate negotiation of site contracts and budgets 3) Assist with development of protocols, CRFs, ICFs, study manuals and study budgets 4) Manage and calculate site payments 5) Perform site visits, including site qualification, initiation, monitoring and closeout visits 6) Co-monitor with regional monitors and review monitoring reports 7) Ensure adherence to protocol, providing for accurate data collection, documenting drug accountability and compliance with federal regulations 8) Represent the company in a professional manner 9) Establish and maintain good relationships with investigators and study site personnel 10) Maintain site contact frequently 11) Prepare and track required documentation and manage study supplies at clinical sites 12) Oversee and track project progress at assigned sites (patient status, safety/adverse events, CRF completion, payments, study drug supply, regulatory documents) 13) Assist with preparing interim study analyses, annual reports and clinical study reports 14) Review data listings on an ongoing basis 15) Assist with planning investigator meetings Requirements 1) BA/BS degree in Nursing, Pharmacy, Life Sciences or a health-related discipline 2) 2 – 3 years of pharmaceutical industry experience, including direct site management 3) In-depth knowledge of GCP, ICH and FDA regulations 4) Superb interpersonal and organizational skills 5) Willingness to work from the office 6) Self-motivated, assertive, with ability to function independently or as part of a team 7) Detail-oriented, with the ability to multi-task and work effectively in a fast-paced environment 8) Excellent communication skills (written and verbal) 9) Willingness to travel (30% – 40%)