Senior Clinical Research Associate

📋 Description

• Ensure successful protocol level execution of SMM deliverables involving start-up, execution, and
• Ensure site related study execution including monitoring visits, site evaluations, site selection
• Maintain clinical trial management systems with site-specific information; provide local regulatory
• Ensure adherence to federal and local regulations, Good Clinical Practices (GCPs), ICH Guidelines
• Ensure audit and inspection readiness of assigned sites; advise on pre-audit activities; prepare
• Coach and mentor CRAs, providing input into their development.

🎯 Requirements

• Bachelor's or equivalent degree, health related (e.g., Medical, Scientific, Nursing, Pharmacy)
• Minimum 5 years of site monitoring experience.
• Strong analytical and critical thinking skills to evaluate complex issues from multiple
• Excellent interpersonal skills with ability to communicate persuasively and with clarity
• Demonstrated proactive and positive team player.
• Strong planning and organizational skills and high level of flexibility in a dynamic environment