Clinical Research Associate II - (US-MA-Andover - 05544)

Minimum Education: None
Job Type: Full Time
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Responsibilities : Responsible for conducting clinical studies to support regulatory submissions as well as the marketing and reimbursement of Smith & Nephew Endoscopy products. Assists in the preparation of clinical study documents such as protocols, case report forms, site monitoring reports, and study summaries. Facilitate surgeon contracts to ensure that clinical projects are completed and the required reports prepared. Assists with market preference evaluations prior to product launch. Provide literature reviews of currently marketed devices. Responsible for some compliance activities within the company including design controls, internal auditing, and assuring compliance with GCP guidelines.

Requirements :Bachelor Degree.5 years experience in medical device industry, clinical setting, or research field.Knowledge of FDA and European Regulations for Clinical TrialsProven problem-solving abilitiesProven organizational skillsSolid experience working with Microsoft Office (Word, Excel, Outlook, Access, Powerpoint).Familiarity with statistical concepts.Up to 50% travel, domestic and international, is required.

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