Senior Informed Consent Specialist

Senior Informed Consent Specialist - 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

We're currently seeking a Senior Informed Consent Form (ICF) Specialist to join our diverse and dynamic team. As an ICF Specialist at ICON, you'll be crucial in ensuring the accuracy, compliance, and timely approval of informed consent forms for clinical trials. Your role will directly contribute to the ethical conduct of clinical research and the successful initiation of studies.

What you'll be doing:

- Developing and reviewing ICFs: Preparing, reviewing, and approving Subject Information Sheets (SIS) and Informed Consent Forms (ICF) for global master templates, country-specific versions, and site-specific adaptations.
- Stakeholder collaboration: Serving as a key point of contact for Sponsors, SSU Project Managers, Clinical Trial Managers, and other functional leads to optimize performance and ensure successful project outcomes.
- Query resolution: Proficiently reviewing, negotiating, and approving all Ethics Committee (EC), Institutional Review Board (IRB), and Competent Authority (CA) queries related to country and site-specific ICFs.
- Timeline management: Forecasting and tracking SIS & ICF approval timelines, proactively identifying risks, and developing contingency plans to mitigate potential impacts.
- Knowledge leadership: Acting as a Subject Matter Expert (SME) for assigned topics, staying updated on changing regulatory and language requirements affecting ICFs, and developing/conducting training.
- Documentation and archiving: Ensuring the accuracy and completeness of ICF documents transferred for filing into the Trial Master File (TMF).
- Mentorship: Mentoring and coaching new hires during their onboarding process.
- Representing FSA: Representing the department at audits, inspections, and on various committees and work groups.

Your profile:

- 5+ years of experience in ICF writing/development.
- Strong English writing and communication skills are required.
- Proficient knowledge of ICH/GCP guidelines and applicable country regulations related to Informed Consent.
- Ability to work collaboratively in a team environment and effectively communicate with diverse stakeholders.
- Strong analytical and problem-solving skills, with excellent attention to detail.
- Protocol interpreting & review is preferred, but not required.

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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.- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.

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