ICF Specialist

ICON Strategic Solutions seeks an ICF Specialist to lead development, review, and oversight of informed consent forms for global clinical trials. Based in the UK, Poland, Spain, or Bulgaria, this sponsor-dedicated role involves ensuring regulatory compliance, ethical standards, and patient readability across complex studies.

Responsibilities

• Review and manage global, country-specific, and site-level ICFs for accuracy, consistency, and protocol alignment
• Assess ICF content for regulatory compliance, ethical standards, and participant readability requirements
• Apply plain language principles to create patient-friendly informed consent documentation
• Identify and escalate quality, compliance, and content issues; coordinate reviews with internal and external partners
• Contribute to development and continuous improvement of ICF templates, processes, and supporting documentation

Requirements

• Minimum two years of experience working with Informed Consent Forms
• Knowledge of ICH-GCP, FDA, EU CTR, and applicable country regulations
• Excellent writing and editing skills with ability to translate technical information into plain language
• Self-starter who works independently and proactively identifies solutions
• Strong detail orientation and ability to manage multiple simultaneous tasks
• Proficiency with Microsoft Office applications
• Good interpersonal and communication skills