Informed Consent Specialist I

Role Overview

Key Responsibilities

• Assist in preparing and reviewing informed consent forms according to protocols, regulations, and sponsor requirements.
• Coordinate ethics committee and regulatory approvals related to informed consent documents.
• Manage consent templates, translations, and version control across countries and sites.
• Answer basic internal questions about consent language and requirements.
• Maintain accurate filing and documentation for audit and inspection readiness.
• Contribute to process improvements and standardisation within the informed consent function.

Required Qualifications and Experience

• Bachelor's degree in life sciences, healthcare, legal studies, or a related field, or equivalent experience.
• Initial experience in clinical research, regulatory affairs, ethics submissions, or document management is preferred.
• Basic understanding of informed consent principles, GCP, and ethical requirements, with willingness to learn.
• Strong attention to detail and organisational skills for managing document versions and timelines.
• Clear written and verbal communication skills with a patient-centred approach.
• Proficiency with MS Office and comfort using document management systems and trackers.

Benefits

• ICON describes its benefits as including annual leave, health insurance, retirement planning, life assurance, employee assistance, and country-specific optional benefits.