Clinical Research Associate II

📋 Description

• Manages study sites to ensure patient safety and high-quality data.
• Guides audit readiness at site/project level; supports audits.
• Maintains trial management tools, status reports, and start-up tasks.
• Conducts site monitoring visits (pre-study to close-out) with timely reports.
• Oversees IP inventory, labeling, storage, reconciliation; data review.
• Communicates with site personnel and sponsors; travels as needed.

🎯 Requirements

• Bachelor's degree or equivalent; 2+ years on-site monitoring; 1 year oncology preferred.
• Proficiency in Microsoft Office: Outlook, Word, Excel, PowerPoint.
• English fluency, strong written/spoken communication, interpersonal skills.
• Knowledge of drug development; ICH-GCP; regulatory guidance; travel 60-70%.
• Preferred: clinical research experience; ability to coordinate site start-up and data quality.