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Job #03095

About our client Our client is a pharmaceutical company based in Northern CA. They concentrate on developing medications for treating severe psychiatric and metabolic diseases. The company has three Phase III clinical trials that have been completed, and currently have a fourth Phase III study, which commenced during Q1 of 2008. It has an experienced CEO and management team on board, exciting product candidates and a team that is committed to the highest standards of integrity and to improving the lives of patients and their families. Position Location Clinical Research Associate Menlo Park, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage and monitor all aspects of clinical study implementation as per FDA regulations, ICH/GCP guidelines and company SOPs 2) Handle on-site and in-house monitoring duties (as needed and required by local and federal regulations) 3) Knowledge and understanding of current regulatory issues related to Phase I – IV clinical research 4) Participate in routine clinical data reviewing (as directed) 5) Contribute to study protocol designing, protocol reviewing and protocol finalization 6) Ensure compliance with quality standards, data management SOPs and guidelines as well as reporting activities 7) Identify and evaluate issues related to the project and implement resolutions 8) Participate in designing and developing CRFs, Informed Consent templates, as well as study-related processes and manuals 9) Conduct site monitoring visits 10) Provide updates to other company departments 11) Liaise and participate in managing study-specific vendors (e.g. CRO, central laboratory, etc.) 12) Provide inputs on departmental decisions related to study processes and procedures Requirements 1) BA/BS with 2 – 3 years of experience as a CRA in the pharmaceutical industry 2) CRA certification a plus 3) Knowledge and understanding of current regulatory issues related to Phase I –IV clinical research 4) Excellent communication and organizational skills 5) Proficiency in Microsoft Word, Excel and PowerPoint 6) Ability to multitask and good time management skills 7) Ability to work independently as well as in a team 8) Ability to prioritize critical path activities above other study-related activities 9) Willingness to travel (30% – 50%)