SSU CRA 2

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global 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 start-up activities.

Your Profile:

You will have a strong foundation in Study Start-Up and Site Activation activities, combined with previous CRA monitoring experience and a thorough understanding of the Mexican regulatory environment.

Required qualifications and experience:

• 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.
• 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.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• 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.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply