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| Job #03056 |
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| About our client |
| Our client is a leading global healthcare supplier that develops, manufactures and distributes over-the-counter (OTC) and prescription pharmaceuticals, nutritional products, active pharmaceutical ingredients (API) and consumer products. |
| Position |
Location |
| Senior Clinical Research Associate |
San Jose, California |
| Salary |
| Highly competitive package, commensurate with experience |
| Responsibilities |
1) Ensure compliance with clinical trials with applicable federal regulations, GCPs, ICH guidelines and the company’s SOPs 2) Coordinate activities of associates and investigators to ensure compliance with protocol and overall clinical objectives 3) Represent the company in the global medical research community 4) Develop collaborative relationships with investigational sites |
| Requirements |
1) Bachelor’s degree in a scientific or healthcare discipline 2) 5 years of experience as a CRA in the pharmaceutical or biotechnology industry 3) Experience in conducting pre-study, initiation and closeout visits 4) Experience in working on multinational clinical studies (preferred) 5) Experience in supporting business development efforts, specifically in offshore locations like India 6) In-depth knowledge of FDA CRFs (11, 50, 54, 312 and 3 as well as ICH GCPs 7) Proficiency in Microsoft applications (Word, Excel and PowerPoint) 8) Excellent organizational and communication (written and oral) skills 9) Ability to work with a minimal amount of supervision 10) Willingness to travel (globally) – up to 50% |

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