Site Specialist I (Regulatory Submissions)
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What you'll do
- Support preparation, process and tracking of site level critical documents and/or of site activation tasks required for site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable regulations/guidelines and the principles of ICH/GCP
- Maintain accurate site information and status updates in clinical trial management systems and trackers.
- Assist with site communications, meeting scheduling, and follow-up on outstanding actions.
- Help prepare materials for site visits, meetings, and audit or inspection activities.
- Ensure site-related documentation is filed correctly to support inspection readiness.
- Collaborate with CRAs, Clinical Site Associates, and project teams to resolve basic site queries.
What they're looking for
- Bachelor's degree in life sciences, healthcare, business, or a related field, or equivalent experience.
- 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.
- Legal right to work in the country where the role is based.
Nice to have
- Initial experience in clinical research, administration, or a similar regulated environment is preferred.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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 I 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.
- Location: Mexico City
- Contract type: Hybrid (office-based with flexibility)
- Requirement: CVs and assessments must be submitted in English
What You Will Do:
Support preparation, process and tracking of site level critical documents and/or of site activation tasks required for site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable regulations/guidelines and the principles of ICH/GCP
Maintain accurate site information and status updates in clinical trial management systems and trackers.
Assist with site communications, meeting scheduling, and follow-up on outstanding actions.
Help prepare materials for site visits, meetings, and audit or inspection activities.
Ensure site-related documentation is filed correctly to support inspection readiness.
Collaborate with CRAs, Clinical Site Associates, and project teams to resolve basic site queries.
Your Profile:
Bachelor's degree in life sciences, healthcare, business, or a related field, or equivalent experience.
Initial experience in clinical research, administration, or a similar regulated environment is preferred.
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
Company
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