06 sep
|
IRE
|
Ciudad de México
06 sep
IRE
Ciudad de México
Informed Consent Specialist II - Homebased - Mexico
ICON is a general 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 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 docu
📌 Informed Consent Specialist II (Ciudad de México)
🏢 IRE
📍 Ciudad de México