Clinical Research Associate, Bilingual

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Syneos Health

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Perform site qualification, initiation, interim monitoring, management, and close-out visits • Evaluate overall performance of site and site staff and develop action plans • Conduct data entry into tracking systems to resolve observations and action items • Prepare for and attend Investigator Meetings and sponsor face-to-face meetings • Provide training or mentorship to junior level CRAs

🎯 Requirements

• Excellent knowledge of ICH/GCP Guidelines or other applicable guidance • Working knowledge of regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice and protocol compliance • Ability to conduct Source Document Review and verify clinical data • Experience with investigational product inventory and reconciliation • Ability to document activities per SOPs and Clinical Monitoring Plan/Site Management Plan

🏖️ Benefits

• Health insurance • Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program

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