Clinical Research Associate (CRA)

Key Responsibilities

• Serve as primary point of contact between Novartis and clinical trial sites, ensuring strong, collaborative partnerships
• Manage assigned Phase I–IV study sites in compliance with protocols, monitoring plans, and regulatory requirements
• Conduct site initiation visits to ensure site teams are fully trained on study protocols and expectations
• Deliver ongoing training for amendments and new site personnel to maintain compliance and consistency
• Perform on-site and remote monitoring activities to ensure patient safety, data integrity, and protocol adherence
• Proactively assess site performance, identifying risks and implementing mitigation strategies to improve outcomes
• Identify process gaps and collaborate with sites to drive continuous improvement and operational excellence
• Promote a strong compliance culture, ensuring adherence to ethical standards, regulations, and data privacy requirements
• Build strong site relationships to enhance patient recruitment and reduce operational challenges
• Lead site closeout activities, ensuring completion of follow-up actions and proper documentation and archiving

Essential Requirements

• Bachelor’s degree in a scientific or healthcare-related discipline
• Minimum 1 year of experience in clinical research, including monitoring or site management
• Understanding of clinical trial processes, including Good Clinical Practice and International Council for Harmonisation guidelines
• Knowledge of applicable regulatory requirements and standards, including global and local health authorities
• Strong communication and relationship-building skills to effectively collaborate with clinical trial sites
• Ability to manage multiple priorities, demonstrating strong organization and time management skills
• Analytical and risk-based thinking with the ability to identify issues and implement effective mitigation strategies
• Fluency in written and spoken English and the local language

Desirable Requirements

• Strong understanding of the drug development process and clinical research methodologies