Clinical Research Associate I/II/Sr.

About the role

This role involves site management and clinical monitoring responsibilities for clinical studies, ensuring adherence to ICH GCP guidelines, SOPs, and regulatory requirements.

Responsibilities

• conducting site visits (Pre-study, Initiation, Monitoring, Close-out)
• verifying subject protection
• reviewing source documents
• managing regulatory documents
• ensuring data integrity and audit readiness
• tracking investigational product inventory
• supporting study team activities
• managing trial systems
• ensuring study timelines and deliverables are met
• training
• site initiation
• participating in meetings

Qualifications

• university degree or healthcare certification
• minimum of 1.5 years of clinical monitoring experience for external candidates or 1 year for internal candidates
• knowledge of ICH GCP, monitoring procedures, and regulatory compliance is essential

Skills

• Phase I monitoring
• life sciences background
• strong organizational and communication skills
• proficiency in clinical systems
• ability to work independently
• attention to detail
• problem-solving abilities
• confidentiality
• effective teamwork

Physical demands include prolonged computer use and travel up to 60% of the time.