Clinical Research Associate

Overview

In this role you will lead site management and monitoring for assigned protocols, ensuring ICH/GCP compliance and high-quality data across a global network. You’ll collaborate with cross-functional teams to expand the site network and support patient safety and study integrity. The position offers exposure to diverse trials and the opportunity to shape site performance and onboarding strategies. You will work in a fast-paced, collaborative environment focused on regulatory excellence and continuous improvement.

Pay / Benefits

• Competitive compensation and benefits

Responsibilities

• Build and maintain strong relationships with investigative sites across trial phases
• Monitor sites in line with ICH-GCP, SOPs, and regulations
• Develop deep understanding of study protocols and procedures
• Coordinate cross-functional tasks to achieve Site Ready status
• Contribute to site selection and validation decisions
• Conduct remote and on-site monitoring to ensure data integrity and subject protection
• Perform validation, initiation, monitoring, and close-out visits with clear documentation
• Manage regulatory documentation for start-up, maintenance, and close-out
• Communicate proactively about protocol conduct, recruitment, deviations, and audits/inspections
• Identify and resolve site performance or compliance issues with escalation pathways
• Partner with internal and external stakeholders and maintain accurate documentation in CTMS/eTMF
• Act as a process SME, share best practices, and deliver training
• Support and/or lead audit/inspection activities
• Contribute to country strategy by onboarding new sites and building site capabilities
• Mentor junior CRAs and conduct co-monitoring and quality control visits

Key requirements

• Fluent in English with strong written and verbal communication
• Robust knowledge of clinical research, ICH/GCP, and local regulations
• Leadership and mentoring capability
• Hands-on knowledge of Good Documentation Practices
• Proven site management and enrollment monitoring experience
• High-level monitoring skills and independent judgment
• Strong IT proficiency (MS Office and clinical applications)
• Ability to interpret data/metrics and act on insights
• Experience with site motivation visits to boost enrollment
• Root cause analysis and corrective action capabilities
• Ability to mentor junior CRAs and perform co-monitoring visits

• Time management
• Organization
• Interpersonal skills
• MS Office
• clinical applications across computer, tablet, and mobile
• CTMS

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