Sr. Clinical Research Associate

 
Location: Newark DE
 Duration: 6 Months+ 

 Under supervision of Clinical Affairs Sr. Manager or Project Manager, works with relevant departments (R&D, Regulatory Affairs, Medical Affairs, Validations, Product Support, Marketing) to aid in design and preparation of clinical and analytical in vitro diagnostic device performance study plans, protocols, and reports, statistical data analysis plans, and associated study data collection forms. 
 Remains current with regulatory requirements for in vitro diagnostic products. 
 With minimum supervision, completes all activities related to the set-up, initiation, execution and close-out of in vitro diagnostic device clinical trials including collection, timely review and analysis of data generated. 
 Schedules and completes on-site monitoring visits to ensure protocol compliance, accuracy and completeness of clinical data. 
 
Knowledge of GCP and Human Subject Protection for the conduct of clinical trials 
 Knowledge of regulatory requirements for in vitro diagnostic products 
 Working knowledge of databases (e.g., Excel, Access), database management, and statistical applications 
 Good knowledge of the in vitro diagnostics industry 
 Good technical background to understand and communicate current and new technologies 
 Laboratory experience is desirable 
 Ability to work on multiple projects simultaneously. 
 Must be able to work within constraints of time and budget 
 25% travel required 
 
 EDUCATION and/or EXPERIENCE 
 B.A./B.S. or equivalent; three to five years related experience and/or training; or equivalent combination of education and experience. 
 

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