ICON seeks an Informed Consent Specialist II to lead development and oversight of informed consent documents for complex global clinical trials. The role involves creating ICFs, advising on consent strategy, managing translations, and liaising with sponsors and regulatory bodies across multiple regions.

Responsibilities

- Lead creation, review, and optimization of integral and local informed consent forms per protocol and regulatory requirements
- Advise study teams on consent strategy, content, and country-specific considerations for complex studies
- Oversee translation processes, version control, and documentation for regional consistency
- Interface with sponsors, ethics committees, and regulatory bodies to address queries and negotiate wording




- Develop templates and best practices; provide training and mentorship to junior team members

Requirements

- Bachelor's degree in relevant scientific or healthcare discipline
- Substantial clinical research, regulatory affairs, or ethics experience with informed consent focus
- Deep knowledge of GCP, ethical guidelines, and global regulatory requirements
- Excellent writing and editing skills; ability to translate complex information for patients
- Strong stakeholder management and cross-functional communication abilities
- Proven capability managing multiple studies with high accuracy and initiative

📌 Informed Consent Specialist II (España)
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📍 España