- Location
- Mexico, Mexico City
- Workplace
- Onsite
- Type
- Full-time
- Education
- Bachelor
- Visa
- Not sponsored
- Source
- Workday
Description
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
As a Site Specialist II at ICON, you will support investigator sites with key administrative and operational activities to help ensure clinical trials run smoothly, efficiently, and in compliance with applicable regulations.
Key responsibilities:
- Lead the preparation, compilation, and quality review of submission packages for Ethics Committee (EC/IRB) review, ensuring all required documentation is complete, accurate, and submitted within established timelines.
- Develop and execute regulatory strategies for Ministry of Health submissions, including COFEPRIS (Mexico) and other applicable local regulatory authorities, to support efficient approval pathways and study activation timelines.
- Coordinate with internal stakeholders, sponsors, investigator sites, and regulatory authorities to address queries, deficiencies, and requests for additional information arising from Ethics Committee and Ministry of Health reviews.
- Provide regulatory guidance to investigator sites on local requirements, ensuring compliance with applicable regulations, ICH-GCP guidelines, and sponsor expectations throughout study start-up and maintenance activities.
- Monitor changes in local regulatory and ethics requirements, assess potential impacts on study timelines, and implement mitigation strategies to minimize activation delays.
- Maintain complete, accurate, and inspection-ready regulatory documentation within the Trial Master File (TMF) and other applicable systems in accordance with ICON quality standards.
- Support country-specific regulatory intelligence and contribute to process improvements that enhance study start-up efficiency, site engagement, and compliance.
Your Profile:
Bachelor's degree in life sciences, healthcare, business, or a related field, or equivalent experience.
Experience in CRO
Strong organizational skills and attention to detail, with the ability to manage multiple tasks and timelines.
Good communication skills and a customer-focused approach to supporting sites and internal colleagues.
Comfort working with spreadsheets, databases, and standard office software.
Willingness to learn clinical trial processes, GCP principles, and site operations.
#LI-FP1
#LI-Hybrid
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
