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 Job #02946 Email this job to a friend
About our client
Our client is one of the largest generic pharmaceutical companies across the world.
Position Location
Senior Clinical Research Associate New York
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Identify and oversee CROs and consultants
2) Coordinate all necessary activities, including protocols, setting up, monitoring and reporting of bio studies in support of ANDAs
3) Ensure all bio studies are conducted in accordance with applicable regulatory guidelines
4) Discuss study design and results with team members
5) Conduct site visits and monitor clinical studies
6) Maintain professional, product and market expertise via independent reading, networking and training
7) Analyze and evaluate data from clinical sites to ensure completeness as well as accuracy
Requirements
1) Degree (4 year) in Life Sciences or a related field
2) CRA certification a plus
3) Knowledge and understanding of GCPs, drug development process as well as regulatory pathways for clinical trials
4) Familiarity with managing overseas staff and experience in clinical monitoring

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