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| Job #02408 |
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| About our client |
| Our client is a publicly traded biopharmaceutical company headquartered in Silicon Valley that is dedicated to the development and commercialization of therapeutics for treatment of nephrology and oncology indications. The company has an experienced management team, strong financials, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. |
| Position |
Location |
| Senior Clinical Research Associate |
Silicon Valley, California |
| Salary |
| Highly competitive package, commensurate with experience |
| Responsibilities |
1) Participate actively in the CRO/vendor identification/selection process 2) Manage CROs/vendors for assigned trials 3) Develop/manage vendor/investigator budget and payment process 4) Oversee study activities such as investigator recruitment, start-up, enrollment, monitoring, data collection, reporting, etc. 5) Prepare study progress updates and develop study documents, including protocols, amendments, CRFs and ICFs 6) Contribute to clinical SOP development |
| Requirements |
1) Bachelor’s degree in a scientific discipline 2) 5+ years of clinical trial experience in the pharmaceutical or biotech industry 3) Minimum 5 years of field monitoring experience 4) Oncology or nephrology (renal/kidney) preferred 5) Experience in monitoring clinical trials from qualification to closeout 6) CRO management experience 7) Strong knowledge and understanding of FDA regulations and GCPs 8) Demonstrated skill in study budget development 9) Team-oriented, flexible, energetic and interested in professional growth 10) Exceptional communication skills 11) Willingness to travel – up to 15-20% |

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