Informed Consent Specialist I
Core
Develop, review, and approve Subject Information Sheets (SIS) and Informed Consent Forms (ICF) for global master templates, country-specific versions, and site-specific adaptations to ensure ethical conduct of clinical research.
Role type
Informed Consent Specialist I (Clinical Research Operations)
Builds
Global master templates, country-specific versions, and site-specific adaptations of Informed Consent Forms (ICF) and Subject Information Sheets (SIS)
Domain
Clinical research / Healthcare intelligence
Required skills
ICF writing and development, ICH/GCP guidelines knowledge, country regulations knowledge, query resolution, timeline management, documentation archiving, stakeholder collaboration
Preferred skills
Protocol interpreting and review
Technologies
Trial Master File (TMF), Ethics Committee (EC), Institutional Review Board (IRB), Competent Authority (CA)
Responsibilities
Develop and review ICFs for global, country-specific, and site-specific versions; Ensure compliance with ICON SOPs/WPs, ICH/GCP guidelines, and country regulations; Resolve queries from Ethics Committees, IRBs, and Competent Authorities; Forecast and track SIS & ICF approval timelines; Act as Subject Matter Expert (SME) and conduct training; Mentor new hires; Represent the department at audits and inspections.
