Senior Clinical Research Associate

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Thermo Fisher Scientific

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Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+

Description

• Monitors investigator sites with a risk-based monitoring approach • Ensures data accuracy through SDR, SDV, and CRF reviews as applicable • Documents observations in reports and letters timely using approved writing standards • Conducts monitoring tasks in accordance with the approved monitoring plan • Initiates clinical trial sites according to the relevant procedures. • Mentors new members, assists in project publications/tools preparation, and shares improvement ideas.

Requirements

• Bachelor’s degree in Biology, Science, Chemistry or related field • Three (3) years of experience in the job offered or as a Clinical Research Associate II, Clinical Research Associate I, Remote Site Monitor or related role. • Three (3) years of experience with clinical monitoring, FDA guidelines, ICH GCPs, applicable regulations and procedural documents, risk-based monitoring concepts and processes, use of various clinical systems, Root Cause analysis, monitoring visit reporting, and site management.