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Sterling Life Sciences, Specialists in Pharmaceuticals, Healthcare and BioTech Recruitment
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 Job #02489 Email this job to a friend
About our client
Our client is a leading medical device company with over 2000 employees. Along with some of the strongest financial indicators in the industry the company boasts an experienced management team and a robust pipeline. They also offer an empowering corporate culture that is focused on the professional development and advancement of clinical team members.
Position Location
Clinical Research Associate Midwest, USA
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Monitor clinical studies and coordinate clinical activities to ensure compliance with protocol and overall clinical objectives
2) Coordinate study management activities, including regulatory document management, site selection, study start-up activities, study information tracking and site management
3) Analyze and evaluate all clinical data collected from the clinical sites to ensure complete and accurate data
4) Assist with the training of new clinical research associates
5) Coordinate and resolve all inquiries and problems associated with clinical investigations
6) Assist with selection of appropriate study sites to conduct clinical studies
7) Maintain a high level of professional expertise through familiarity with clinical literature and participation in project meetings
8) Assist with the review and development of clinical protocols and associated study documents
9) Prepare clinical reports as needed for regulatory submissions and upon request, when required for presentations
10) Assist with the training of new clinical research associates
Requirements
1) Bachelor's degree in a scientific discipline
2) 5+ years of clinical trial experience in the pharmaceutical or biotech industry
3) Experience in monitoring clinical studies from qualification to closeout
4) Strong knowledge and understanding of FDA regulations and GCPs
5) Exceptional communication skills
6) Excellent organization and time management skills
7) Willingness to travel – up to 65% (overnight)

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