Job Title
Clinical Research Associate
Job Profile
Regeneron is a biopharmaceutical Company that discovers, develops, and commercializes therapeutic medicines for the treatment of serious medical conditions. Regeneron currently markets ARCALYST (rilonacept) Injection for subcutaneous use for the treatment of a rare, inherited, inflammatory condition. The company has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases and inflammatory diseases, and has preclinical programs in other diseases and disorders.
With a strong research base and product focus, Regeneron is able to understand thoroughly the biology of specific disease states, discover potential therapeutic candidates and evaluate product candidates in clinical trials. Regeneron has developed several proprietary platform technologies, which it has incorporated into a comprehensive system that allows it to accelerate the discovery and design of fully human antibodies and move these candidates rapidly into clinical development.
Position Summary:
The CRA supports the Clinical Trials team(s) in the initiation, maintenance and closeout of clinical projects according to GCP, ICH, CFR and Regeneron SOPs, and reporting of study progress. May accompany team members to sites to observe and provide input and recommendations regarding site selection, initiation, monitoring or close out visits as required. Receives assignments through general instructions (routine work); more detailed instruction is provided for new projects.
Provides support for clinical trials including, but not limited to:
-Reviews study document quality
-Collects data and studies results for abstract preparation
-Assists with the study budget and contracting process
-Generates HIPAA agreements, ICF (templates and final site drafts), financial disclosure forms and periodic newsletters
-Works under direct supervision
-Receives general instruction in order to complete routine work assignments, and more detailed instruction for new projects.
-Applies knowledge of company policies and standard practices to resolve problems.
Experience:
-BS 2-5 years of clinical project, trial management experience or an advanced degree with relevant experience.
-Fundamental knowledge of the clinical research process and regulations / guidelines.
-Familiarity with medical terminology.
-Effective problem solving and communication in individual and group settings.
-Proficient in Microsoft Office applications.
-Typical Office Equipment on and off-site, Microsoft Office Programs, and MS Project.
We offer an extremely competitive compensation and benefits package including stock incentives, 401k with company match as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.
EOE/M/F/D/V
Job URL
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Location: USA-NY-Tarrytown |
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Date Last Verified
Sep 08,2010 |
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Posted on
Jul 29,2010 |
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Company info
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