Core ICF Developer/Writer and Reviewer (Centralized role)
Join to apply for the
Core ICF Developer/Writer and Reviewer (Centralized role)
at
Fortrea.
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 content aligns with the protocol and fully informs potential research subjects.
Guarantee that documents are understandable, comply with industry standards, and include client-specific guidance.
Support development, review, and approval of master templates for protocol and site activation.
Create, review, and revise training materials and plans.
Communicate effectively with stakeholders, including reporting trends, issues, and safety concerns.
Skills
Strong knowledge of drug development, FDA IND/NDA requirements, and clinical trial regulations.
Understanding of medical terminology and health literacy principles is a plus.
Excellent customer service, communication, and computer skills (MS Word).
Ability to influence, plan, prioritize, pay attention to detail, and mentor others.
Adaptability to a fast-paced environment.
Requirements
University/College Degree (medical degree preferred).
5+ years of experience in writing/editing clinical trial documents.
Advanced English proficiency (oral and written).
Strong knowledge of ICH-GCP and relevant regulations.
Relevant domain knowledge accepted if appropriate.
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