Study Start-Up CRA II role overseeing site activation and clinical trial initiation in Mexico City. Responsible for managing site start-up activities, regulatory submissions, and ensuring compliance with local regulations and ICH-GCP guidelines while maintaining stakeholder relationships.
Responsibilities
Oversee site start-up and activation activities aligned with study timelines and sponsor expectations
Prepare and coordinate regulatory submissions to Ethics Committees and authorities per local requirements
Ensure compliance with current Mexican regulations and recent COFEPRIS requirements
Collect, review, and maintain regulatory documentation for site activation with investigative sites
Identify and resolve start-up challenges collaborating with cross-functional teams
Requirements




Bachelor's degree in scientific or healthcare-related field
Strong experience in study start-up and site activation within CRO or clinical research organization
Prior Clinical Research Associate monitoring experience and site management knowledge
Comprehensive knowledge of ICH-GCP, Ethics Committee processes, and essential document management
Current understanding of COFEPRIS regulations and recent Mexican regulatory changes
Ability to manage multiple sites and projects with strong organizational skills
Experience with clinical trial management systems and eTMF platforms

📌 Ssu Cra 2 (Xico)
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📍 Xico