Clinical Research Associate II

📋 Description

• Oversees all aspects of site management to protect patient safety and data quality.
• Performs site visits (pre-study, initiation, routine monitoring, close-out).
• Maintains trial management tools, status reports, and data quality.
• Manages site start-up tasks including feasibility, regulatory documents, EC/IRB submissions.
• Assists with negotiation of budgets and investigator contracts under Site Contract Management.
• Verifies informed consent and assesses safety and data integrity at sites.

🎯 Requirements

• Bachelor's degree or international equivalent in a science/healthcare discipline.
• Minimum 2 years on-site monitoring; 1 year oncology and Phase I preferred.
• Proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint).
• Fluency in English; strong interpersonal and teamwork skills.
• Knowledge of ICH-GCP, regulatory guidance, and drug development.
• Willingness to travel 60-70%.

🎁 Benefits

• Remote work environment
• Equal opportunity employer
• Opportunity to work on cutting-edge cancer therapies
• Collaborative, supportive team with growth opportunities