Clinical Research Associate II responsible for site management and monitoring of clinical trials at a Mexico City location. Conducts pre-study through close-out monitoring activities, ensures protocol adherence and data integrity, and maintains regulatory compliance according to ICH GCP guidelines and company procedures.
Responsibilities
Conduct site initiation, routine, and close-out monitoring visits per SOPs and ICH GCP
Perform 100% source document verification, query generation, and data integrity review
Verify informed consent procedures, protocol adherence, and subject protection measures
Manage investigational product inventory, accountability, and secure storage
Prepare monitoring plans, trip reports, and site initiation documentation
Requirements
University degree or allied health certification (nursing licensure acceptable)
Minimum 2 years clinical monitoring experience
Fluent in Spanish and English, written and verbal
Thorough knowledge of ICH GCP guidelines and local regulatory requirements
Ability to work independently with minimal supervision
Understanding of serious adverse event reporting and follow-up procedures
Strong organizational, planning, and problem-solving abilities

📌 Cra Ii (Xico)
🏢 Fortrea
📍 Xico