Study Start-Up CRA II (Remote)

About the role

ICON Strategic Solutions is hiring a Study Start-Up CRA II in Mexico City, working remotely in a sponsor-dedicated model. The role oversees site start-up and activation so that clinical trials begin efficiently and in line with protocol requirements, local regulations and industry standards, while keeping strong relationships with investigative sites and cross-functional stakeholders.

Key responsibilities

• Lead study start-up activities, managing site activation and regulatory submissions with a focus on quality, compliance and timely delivery.
• Prepare, review and coordinate submissions to Ethics Committees and regulatory authorities in line with local requirements and ICH-GCP guidelines.
• Ensure compliance with current local regulations, including recent COFEPRIS updates affecting clinical trial start-up in Mexico.
• Work with sites to collect, review and maintain the regulatory documentation needed for activation.
• Collaborate with cross-functional teams to resolve start-up issues and assess site readiness using prior site monitoring experience.
• Build and maintain relationships with site personnel and stakeholders.

Required profile

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• Strong experience in study start-up and site activation within a CRO, sponsor or clinical research organization.
• Previous CRA monitoring experience with a solid understanding of site management and clinical trial conduct.
• Proven ability to manage multiple sites and projects at once, with strong organisational and problem-solving skills.
• Willingness to travel approximately 25% of the time; employment requires the legal right to work in Mexico.

Required skills

• Knowledge of ICH-GCP, Ethics Committee processes, document management and clinical trial start-up requirements.
• Up-to-date understanding of COFEPRIS regulations and recent regulatory changes in Mexico.
• Experience with clinical trial systems such as CTMS and eTMF platforms.
• Excellent communication, interpersonal and stakeholder management skills.

What we offer

• 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 learning and development opportunities.