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Clinical Affairs Specialist- Remote available
The Clinical Affairs Specialist will provide guidance to study sponsors and IVD medical device manufacturers in support of clinical study design and execution.  Responsible for the development of clinical study protocols and implementation of those protocols at study sites.  Develops and implements strategies in a collaborative environment between colleagues and clients with the goal of successful regulatory submissions.   RESPONSIBILITIES: Development and execution of clinical study strategies and protocols to support the validation of new medical and in vitro diagnostic devices. Prepare and present clinical study protocols and reports for regulatory bodies including the US FDA. Creation of Clinical and Analytical Study Prot


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