About the role
Mexico City. Remote.
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%).
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
Bachelor's degree in a scientific or healthcare field; strong study start-up and site activation experience; CRA monitoring experience; knowledge of ICH-GCP, COFEPRIS regulations; CTMS and eTMF experience; based in Mexico City; 25% travel.
Key Responsibilities
- managing site start-up
- preparing regulatory submissions
- collaborating with sites
Skills & Tools
CTMS, eTMF
Job Details
- Category: Healthcare Services - Allied Health
- Seniority: Mid Level
- Commitment: Full Time
- Workplace: Remote — Mexico City, Mexico City, Mexico
- Languages: English
Benefits
- Generous paid time off
- Retirement plan
About ICON plc
A global clinical research organization providing study start-up and site activation services. — Industry: Healthcare