Mexico City. Remote.

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s general expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Study Start-Up CRA II at ICON Plc, you will oversee and manage site start-up and activation activities to ensure clinical trials are initiated efficiently and in compliance with protocol requirements, local regulations, and industry standards. You will serve as a key contributor in driving site activation timelines while maintaining strong relationships with investigative sites and cross-functional stakeholders.

What You Will Do

You will lead study start-up activities requiring technical expertise in site activation, regulatory submissions, and clinical trial operations, with a focus on quality, compliance, and timely delivery.

Key Responsibilities Include





• Managing site start-up and activation activities to ensure sites are activated according to study timelines and sponsor expectations.
• Preparing, reviewing, and coordinating submissions to Ethics Committees and regulatory authorities in accordance with local requirements and ICH-GCP guidelines.
• Ensuring compliance with current local regulations, including recent COFEPRIS updates and requirements impacting clinical trial start-up in Mexico.
• Collaborating with investigative sites to collect, review, and maintain essential regulatory documentation required for site activation.
• Working closely with cross-functional teams to identify and resolve start-up challenges and ensure successful study delivery.
• Leveraging prior site monitoring experience to assess site readiness and proactively identify operational risks.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth study star

📌 SSU CRA 2 (México)
🏢 ICON Strategic Solutions
📍 México