Core ICF Developer/Writer and Reviewer (Centralized role)

Core ICF Developer/Writer and Reviewer (Centralized role)

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Responsibilities:

• Develop, review, finalize, and maintain clinical trial documents such as informed consent forms.
• Apply knowledge of GCP Guidelines, regulatory requirements, privacy standards, biological samples standards, therapeutic areas, and IMPs to review and develop ICFs.
• Ensure the content of the Master ICF aligns with the protocol and fully informs potential research subjects.
• Write/edit documents in compliance with global industry standards and client-specific guidance.
• Support development, review, and approval of master templates for protocol/site activation.
• Create and revise training materials and plans.
• Communicate effectively with stakeholders, including liaising with PM/Designee regarding trends, issues, or safety concerns.