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Job #02633

About our client Our client is a specialty pharmaceutical company focused on the development and commercialization of modern medical treatments utilizing its proprietary polymer-based drug delivery systems. Position Location Clinical Research Associate San Francisco/Redwood City, California Salary Reports to Highly competitive package, commensurate with experience Management Responsibilities 1) Set up, monitor and complete clinical trials 2) Initiate, qualify clinical sites and monitor the progress of clinical study in individual centers as per Good Clinical Practices 3) Inspect, collect and maintain all appropriate regulatory and IRB/ethics committee documentation as well as all pertinent correspondence (telephone calls, emails, letters) with investigative sites 4) Manage regulatory authority applications and approvals 5) Oversee the research and marketing of new and existing drugs 6) Locate and assess the suitability of facilities of investigative sites (site qualification) 7) Set up investigative sites, which includes ensuring that each site has the required regulatory and study documentation as well as the required test and control drug supplies 8) Brief the investigators and relevant personnel on conducting the clinical study 9) Monitor the trial throughout its duration, which involves visiting the study sites on a regular basis to ensure that Good Clinical Practices (GCPs) and relevant ethics regulatory requirements are followed 10) Perform the closing down of study centers by finalizing all appropriate documentation at the investigative site on completion of the trial 11) Verify that data entered on to the Case Report Forms (CRFs) is consistent with source documentation (patient charts, clinical notes, nursing notes, prescription information) 12) Collect the completed CRFs from investigative sites and forward them to data management personnel (either in-house or off-site) 13) Assist the data management personnel in data entry by responding to clarifications 14) Work with the database management personnel (either in-house or off-site), medical and safety monitors to clarify all generated queries and/or collect additional information required for adverse event reporting 15) Write visit reports 16) Examine the submitted invoices from investigative sites and other supporting vendors against relevant records 17) Ensure that all investigative drug(s) or biologic(s) supplies are accounted for 18) Maintain and archive study documentation (regulatory, institutional review board and ethics committee approvals and correspondence with the site) as well as all relevant correspondence (telephone calls, emails, letters) 19) Develop and write trial protocols (outlining the purpose and methodology of a trial) 20) Design the data collection forms, known as Case Record Forms (CRFs) 21) Coordinate with the ethics committee to safeguard the rights, safety and well-being of all trial subjects 22) Prepare or assist in the preparation of final reports Requirements 1) Bachelor's degree in Life Sciences 2) 5+ years of experience in a clinical development environment 3) 2+ years of experience as a Clinical Research Associate 4) Experience in oncology preferred 5) 2 years of site monitoring experience 6) Experience in planning and generating clinical submission documents 7) Good understanding of GCPs and regulatory documents 8) Exceptional communication skills