Core ICF Developer/Writer and Reviewer

4 semanas atrás

São Paulo, São Paulo, Brasil Fortrea Tempo inteiro
Core ICF Developer/Writer and Reviewer (Centralized role)

Join to apply for the Core ICF Developer/Writer and Reviewer (Centralized role) at Fortrea .

Job Title

Core ICF Developer/Writer and Reviewer (Centralized role)

Posted

5 days ago - Be among the first 25 applicants

Responsibilities
  1. Develop, review, finalize, and maintain clinical trial documents such as informed consent forms.
  2. Apply knowledge of GCP Guidelines, regulatory requirements, privacy standards, biological sample standards, therapeutic areas, and IMPs to review and develop ICFs.
  3. Ensure the content of the Master ICF aligns with the protocol and provides comprehensive information for potential research subjects.
  4. Ensure the consent form is understandable, clear, and complies with global industry standards.
  5. Include client-specific guidance during development and review of the Master ICF.
  6. Support the development, review, and approval of master templates for protocol/site activation.
  7. Create and revise training materials and plans for the team.
  8. Communicate timely and effectively with stakeholders regarding project trends, issues, safety concerns, and other relevant activities.
  9. Liaise with PM/Designee about activities impacting trial delivery or patient safety.
Skills
  • Strong knowledge of drug development process and FDA IND/NDA requirements.
  • Understanding of clinical trial regulations including FDA, GDPR, and GCP guidelines.
  • Knowledge of medical terminology and health literacy principles is a plus.
  • Excellent customer service and management skills.
  • Proficiency in MS Word and command of the English language.
  • Ability to influence stakeholders, plan, prioritize, and deliver work on time.
  • Attention to detail and ability to produce high-quality work.
  • Negotiation, mentoring, and adaptability skills.
Requirements
  • University/College Degree (medical degree preferred).
  • Minimum of 5 years experience in writing/editing clinical trial documents.
  • Advanced English skills (oral and written).
  • Strong knowledge of ICH-GCP guidelines and applicable regulations.
  • Relevant domain knowledge and experience may be considered for non-medical/life sciences backgrounds.
Additional Information

Seniority level: Mid-Senior level

Employment type: Full-time

Job function: Engineering and Information Technology

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