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US: Clinical Research Associate

Date: 21-Feb-2014
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Clinical Research Associate

Independently performs monitoring visits, including Pre-Study, Study Site Initiation, routine/interim Monitoring and Study Site Closure visits in accordance to Aptiv Solutions Quality Documents and monitoring plan/conventions First point of contact for investigators and site staff and maintains regular contact with study site to ensure ICH-GCP/Regulatory/Protocol compliance, assessment of subject accrual rates and respond to sponsor/internal team prior, during and following site visits. Works with site personnel and study team to identify resolve and prevent issues

Bachelorís degree or equivalent in a medical, clinical, scientific or related field from an accredited institution At least 2 years previous CRA experience with oncology A minimum of 3 years of total monitoring experience Must have good understanding of ICH-GCP, applicable regulations and monitoring practices with a track record for ensuring quality data and performing superb site management. Must be able to use initiative and work within an international team Must have a valid driverís license and be willing to travel up to 80% A strong customer service orientation

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BioTech FYI Center