Informed Consent Specialist II

About the role

The Informed Consent Specialist II will prepare, review, approve, process and track Subject Information Sheets (SIS) and Informed Consent Forms (ICF) for study site activation and conduct, ensuring compliance with ICON SOPs, sponsor requirements and applicable regulations.

Key responsibilities

• Maintain proficiency in ICON SOPs/WPs, ICH/GCP and country-specific regulations related to informed consent.
• Enter and communicate progress of SIS and ICF activities in tracking systems and serve as main contact for sponsors and project managers.
• Act as Subject Matter Expert, stay updated on regulatory and language changes, and coordinate translations when needed.
• Review, negotiate and approve Ethics Committee, IRB and Competent Authority queries.
• Forecast approval timelines, provide risk assessments and escalations, and ensure documents are correctly filed in the Trial Master File.

Required profile

• Bachelor’s degree.
• 3‑6 years of experience in a clinical research environment.
• Strong communication, judgment and decision‑making abilities.
• Proficiency in English and the language(s) required for assigned countries.

Required skills

• Knowledge of ICON SOPs/WPs, ICH/GCP and relevant regulatory guidelines.
• Experience with informed consent documentation and tracking systems.
• Ability to train and mentor junior staff.

What we offer

• Competitive base salary and performance incentives.
• Health, dental and vision coverage, retirement plans and life/disability insurance.
• Learning and development opportunities through structured training.