[Hiring] Study Start-Up CRA II @ICON plc

Role Description

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:

• 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.
• Manage site start-up and activation activities to ensure sites are activated according to study timelines and sponsor expectations.
• Prepare, review, and coordinate submissions to Ethics Committees and regulatory authorities in accordance with local requirements and ICH-GCP guidelines.
• Ensure compliance with current local regulations, including recent COFEPRIS updates and requirements impacting clinical trial start-up in Mexico.
• Collaborate with investigative sites to collect, review, and maintain essential regulatory documentation required for site activation.
• Work closely with cross-functional teams to identify and resolve start-up challenges and ensure successful study delivery.
• Leverage prior site monitoring experience to assess site readiness and proactively identify operational risks.
• Build and maintain effective relationships with site personnel and stakeholders to facilitate smooth study start-up activities.

Qualifications

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• Strong experience in Study Start-Up and Site Activation activities within a CRO, sponsor, or clinical research organization.
• Previous Clinical Research Associate (CRA) monitoring experience, with a solid understanding of site management and clinical trial conduct.
• Strong knowledge of ICH-GCP, Ethics Committee processes, essential document management, and clinical trial start-up requirements.
• Up-to-date understanding of COFEPRIS regulations and recent regulatory changes impacting clinical trial submissions and site activation in Mexico.
• Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.
• Experience working with clinical trial systems, including CTMS and eTMF platforms.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to collaborate effectively within global cross-functional teams.

Requirements

• Based in Mexico City, Mexico.
• Willingness to travel as required (approximately 25%).
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Benefits

• Competitive base salary and performance related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.
• Benefits may vary depending on role and location.