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Job #02632

About our client Our client is a clinical-stage biopharmaceutical company headquartered in Mountain View, California, that focuses on the development and discovery of various orally-administered therapeutics. Position Location Clinical Research Associate Mountain View, California (Bay Area) Salary Reports to Highly competitive package, commensurate with experience Management Responsibilities 1) Draft vendor/CRO request for proposal 2) Review RFPs critically 3) Serve as a key or primary contact with the CROs/vendors 4) Conduct on-site visits to identify as well as evaluate investigators 5) Assist with study start-up activities, including interactions with vendors, Case Report Form (CRF) development, collection of regulatory documents and finalizing investigator contracts 6) Monitor Case Report Forms and source documents for completeness, accuracy and adherence to protocols 7) Interact with CROs and CRFs 8) Track study progress and identify data points 9) Provide systems for a high-level time efficiency and low edit rate 10) Review data and data collection methods 11) Assist with all study closeouts activities, including a final audit and reconciliation of the clinical data, study file and investigator file 12) Keep updated knowledge of clinical and regulatory practices, GCPs and ICH guidelines 13) Provide critical review of protocol and review/originate protocol amendment and CRFs 14) Supervise and train junior CRAs 15) Perform clinical audit of clinical files and site files 16) Participate in the review and assessment of CROs/other vendors 17) Assume budget and oversee forecasting and accountability Requirements 1) 2 – 5 years of on-site monitoring experience 2) Computer literate 3) Ability to work independently in a deadline-driven environment 4) Ability to contribute to overall clinical operation strategies 5) Proven leadership skills 6) Excellent communication (written and verbal) skills 7) Willingness to travel – up to 50%