Core Icf Developer

hace 2 semanas


Xico, México Fortrea A tiempo completo

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). Requirements University / College Degree (medical degree preferred). 5+ years of experience in writing / editing clinical trial documents. Advanced English proficiency (oral and written). Ability to influence, plan, prioritize, pay attention to detail, and mentor others. Adaptability to a fast-paced environment. Domain Knowledge Strong knowledge of ICH-GCP and relevant regulations. Relevant domain knowledge accepted if appropriate. #J-18808-Ljbffr


  • Core Icf Developer

    hace 2 semanas


    Xico, México Fortrea A tiempo completo

    Core ICF Developer / Writer and Reviewer (Centralized role)Join to apply for the Core ICF Developer / Writer and Reviewer (Centralized role) at Fortrea.ResponsibilitiesDevelop, review, finalize, and maintain clinical trial documents such as informed consent forms.Apply knowledge of GCP Guidelines, regulatory requirements, privacy standards, biological...

  • Core Icf Developer

    hace 2 semanas


    Xico, México Fortrea A tiempo completo

    Core ICF Developer / Writer and Reviewer (Centralized role)Join to apply for the Core ICF Developer / Writer and Reviewer (Centralized role) at Fortrea.ResponsibilitiesDevelop, review, finalize, and maintain clinical trial documents such as informed consent forms.Apply knowledge of GCP Guidelines, regulatory requirements, privacy standards, biological...


  • Xico, México Fortrea A tiempo completo

    A leading clinical research organization in Mexico is seeking a Core ICF Developer / Writer and Reviewer. This role involves developing and maintaining clinical trial documents, ensuring compliance with regulatory standards, and effective communication with stakeholders. The ideal candidate has over 5 years of experience in clinical document writing, a...


  • Xico, México Fortrea A tiempo completo

    A leading clinical research organization in Mexico is seeking a Core ICF Developer / Writer and Reviewer. This role involves developing and maintaining clinical trial documents, ensuring compliance with regulatory standards, and effective communication with stakeholders. The ideal candidate has over 5 years of experience in clinical document writing, a...

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