Informed Consent Specialist I

About the role

ICON is seeking an Informed Consent Form (ICF) Specialist to ensure the accuracy, compliance, and timely approval of informed consent documents for clinical trials. The role supports ethical research conduct and successful study initiation.

Key responsibilities

• Prepare, review, and approve Subject Information Sheets (SIS) and ICFs for global master templates, country‑specific versions, and site‑specific adaptations.
• Apply ICON SOPs, ICH/GCP guidelines, and relevant country regulations to maintain compliance.
• Serve as primary contact for sponsors, project managers, and clinical trial leads to optimise performance.
• Review, negotiate, and approve queries from Ethics Committees, IRBs, and Competent Authorities.
• Forecast and track SIS & ICF approval timelines, identify risks and develop mitigation plans.
• Act as SME on assigned topics, stay updated on regulatory changes, and deliver training.
• Ensure accurate archiving of ICF documents in the Trial Master File.
• Mentor new hires and represent the department during audits and inspections.

Required profile

• Minimum 1 year of experience in ICF writing or development.
• Strong English writing and communication skills.
• Proficient knowledge of ICH/GCP guidelines and applicable country regulations.
• Ability to work collaboratively with diverse stakeholders.
• Excellent analytical, problem‑solving and attention‑to‑detail abilities.

Required skills

• ICH/GCP regulatory knowledge
• Informed consent form development

What we offer

• Competitive base salary and performance incentives
• Health, dental and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance and wellbeing resources
• Learning and development opportunities