Informed Consent Specialist II - Homebased - Mexico

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

As an Informed Consent Specialist II at ICON, you will independently manage informed consent activities across clinical studies, ensuring documents are compliant, patient-focused, and aligned with regulatory, ethical, and sponsor requirements. You will collaborate with cross-functional teams, provide guidance on informed consent processes, and contribute to continuous improvement initiatives that support quality and efficiency.

What You Will Do:

You will take ownership of informed consent deliverables across multiple clinical research projects, applying your expertise to ensure accuracy, compliance, and operational excellence.

Key responsibilities include:

- Independently preparing, reviewing, and managing informed consent forms (ICFs) and related participant-facing documents in accordance with study protocols, regulations, and sponsor requirements.
- Coordinating informed consent activities across multiple studies, ensuring timelines, quality standards, and deliverables are met.
- Managing ethics committee and regulatory submission activities related to informed consent documents, including approval tracking and issue resolution.
- Overseeing consent templates, translations, version control, and document updates across countries and sites to ensure consistency and compliance.
- Serving as a key point of contact for internal stakeholders, providing guidance on informed consent language, requirements, and document processes.
- Identifying and resolving document discrepancies, compliance risks, and process issues with minimal supervision.




- Ensuring accurate filing, maintenance, and documentation of informed consent materials to support audit and inspection readiness.
- Contributing to the development of process improvements, best practices, templates, and standardization initiatives within the informed consent function.
- Supporting the onboarding, training, and day-to-day guidance of less experienced team members as needed.

Your Profile:

You will bring clinical research experience and a strong understanding of informed consent processes, along with the ability to manage multiple priorities in a dynamic and highly regulated environment.

Required qualifications and experience:

- Bachelor's degree in life sciences, healthcare, legal studies, or a related field, or equivalent experience.
- Experience in clinical research, regulatory affairs, ethics submissions, informed consent management, or a related discipline.
- Good understanding of informed consent principles, ICH-GCP, ethical requirements, and applicable regulatory guidelines governing clinical research.
- Demonstrated ability to independently manage document review processes, timelines, and stakeholder communications.
- Strong attention to detail and organizational skills, with experience managing complex document workflows and competing priorities.
- Effective written and verbal communication skills, with the ability to collaborate across cross-functional and global teams.
- Proficiency with MS Office and experience working with document management systems,



workflow tools, and tracking platforms.
- Ability to identify process improvement opportunities and contribute to initiatives that enhance quality, compliance, and efficiency.

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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.
- General 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.

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.

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📌 Informed Consent Specialist II (México)
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📍 México