SSU CRA I

Mexico. Hybrid.

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

What You Will Do:

• Work independently to coordinate and manage all activities related to study start-up and monitoring, ensuring accurate study status reporting and proper maintenance of study documentation.
• Support and lead site start-up (SSU) activities, including site identification, feasibility assessments, site selection visits (SSVs), and regulatory submissions.
• Draft and review informed consent forms (ICFs) and support the customization/localization of study protocols in line with regulatory and sponsor requirements.
• Run sponsor-generated queries efficiently and contribute to study cost efficiency and budget awareness.
• Participate in the preparation and review of study documentation and feasibility analyses for new proposals.
• Build and maintain strong, collaborative relationships with clinical investigators, site staff, and key stakeholders.
• Ensure patient safety and data integrity by maintaining compliance with SOPs, study protocols, ICH-GCP, and local regulatory requirements.

Your Profile:

• Proven experience in clinical research, with strong exposure to site start-up, regulatory activities, and feasibility processes.
• Hands-on experience drafting Informed Consent Forms (ICFs), supporting protocol customization, and conducting site selection visits.
• Background in roles such as CTA Lead, Senior CTA, or CTA with regulatory experience is highly desirable.
• Solid knowledge of ICH-GCP guidelines and the ability to review and evaluate clinical/medical data.
• Excellent written and verbal communication skills in advanced English.
• Strong interpersonal skills, with the ability to manage queries and stakeholder interactions effectively and in a timely manner.
• Highly organized, detail-oriented, and able to work independently in a fast-paced environment.
• Availability to conduct 1–2 on-site (field) visits based on study needs.

What ICON can offer you:

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.

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