Clinical Research Associates

Company:	ToolMedia
City:	Laval, Quebec
Industry:	Healthcare
Date:	19 Apr `06
Employment:	Full-Time
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You will serve as the primary contact with individual investigational sites that conduct clinical trials. You will perform and coordinate all aspects of the clinical monitoring process, in accordance with ICH GCP and FDA guidelines and global SOPs, to assess the safety and efficacy of investigational products and/or medical devices. And be responsible for ensuring the data will pass international quality assurance audits.

Requirements

You will as necessary, prepare and submit; regulatory, ethics committee and provincial applications and regulatory packages. Also, ensure that the proper essential documents are in place prior to trial start up and on an ongoing basis throughout the study.

 

You will have a life sciences degree or nursing qualification and at least one year’s experience of Phase II to IV trials, you will have an in depth knowledge of FDA and ICH GCP requirements as well as local ethics and regulatory requirements. Senior CRAs will have a minimum of three years experience, including start up, monitoring and close out visits. As a Senior CRA you will have the opportunity to mentor more junior CRAs and may be asked to take on project co-ordination activities as a lead CRA.

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