Clinical Research Associate, Bilingual
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Job Description
Clinical Research Associate managing site qualifications and monitoring for clinical studies at Syneos Health. Utilizing ICH/GCP Guidelines to ensure compliance and support patient recruitment.
Responsibilities:
- 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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