Clinical Research Associate II

Clinical Research Associate II position at ICON in Orlando, FL involving sponsor-dedicated clinical operations. Manages investigational sites across therapeutic areas, conducting monitoring visits, ensuring regulatory compliance, and supporting trial data quality and patient safety.

Responsibilities

• Serve as primary contact between investigational sites and trial sponsor
• Conduct site selection, initiation, routine monitoring, and close-out visits
• Ensure site compliance with ICH-GCP standards, SOPs, and regulatory requirements
• Monitor patient safety and oversee timely adverse event and safety reporting
• Maintain accurate documentation in clinical systems and resolve data queries

Requirements

• Bachelor's degree in Life Sciences or equivalent; RN qualification accepted
• 2+ years on-site monitoring experience in pharmaceutical or CRO industry
• Proficiency in ICH-GCP, CTMS, eTMF, and local regulatory requirements
• Multi-therapeutic area monitoring experience
• Ability to travel 60-75% across southeast region; Orlando residency preferred
• Legal work authorization in United States without visa sponsorship
• Strong communication, problem-solving, and collaborative skills