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Job #02644

About our client Our client is a rapidly growing pharmaceutical company headquartered in San Francisco that is focused on the development and commercialization of cancer therapeutics. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. They continue to be well positioned financially to pursue multiple product candidates in parallel with the goal of bringing new treatment options to cancer patients as quickly as possible. Position Location Senior Clinical Research Associate San Francisco, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Train others to develop protocols and CRFs 2) Review the work of others in development 3) Train others to prepare clinical sites for trial initiation 4) Monitor clinical trials 5) Manage independent contractors and CROs 6) Monitor the clinical trial site taking remedial action (when necessary) 7) Ensure that the written procedures for shipment of supplies are followed and take corrective action if necessary 8) Guide and mentor others 9) Supervise the work of other CRAs 10) Check that appropriate documentation is in place to initiate clinical trials, so that each site is prepared for trial initiation 11) Ensure that all regulatory documents have been submitted to the regulatory affairs 12) Create study-related procedures to clinical-site staff at an investigator meeting or an initiation meeting at the site 13) Develop and review clinical protocols and CRFs in consultation with medical monitor 14) Create study-related tools 15) Direct the activities of contractors Requirements 1) Bachelor's degree in a scientific discipline/RN or BSN or equivalent 2) 6+ years of experience in clinical trials or a related field, including CRA experience in a pharmaceutical company 3) Good knowledge of FDA regulations and ICH/GCP guidelines 4) Strong knowledge of clinical issues in more than one therapeutic field 5) Good attention to detail 6) Ability to work under general supervision 7) Ability to take a leadership role in initiating and monitoring clinical trials 8) Strong monitoring skills 9) Superior communication (verbal and written) and organization skills 10) Willingness to travel – up to 50%