Clinical Research Associate II

📋 Description

• Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical
• Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices
• Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4
• Overviews the overall activities of site personnel over whom there is no direct authority and
• Ensures regulatory inspection readiness at assigned clinical sites.
• Ensures quality of data submitted from study sites and assures timely submission of data, including

🎯 Requirements

• Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred.
• Site Monitoring Experience: Minimum 3 years.
• Experience in on-site monitoring of investigational drug or device trials is required.
• Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate
• Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and
• Strong planning and organizational skills and the ability to work effectively and efficiently in a