Clinical Trial Document Specialist
Há 7 dias
Join a team to apply for a role that involves developing, reviewing and maintaining clinical trial documents. This includes informed consent forms and other relevant materials.
Responsibilities- Develop, review and finalize clinical trial documents such as informed consent forms.
- Apply knowledge of GCP Guidelines, regulatory requirements, privacy standards and therapeutic areas to review and develop ICFs.
- Ensure the content of the Master ICF aligns with the protocol and provides comprehensive information for potential research subjects.
- Ensure the consent form is understandable, clear and complies with global industry standards.
- Include client-specific guidance during development and review of the Master ICF.
- Support the development, review and approval of master templates for protocol/site activation.
- Create and revise training materials and plans for the team.
- Communicate timely and effectively with stakeholders regarding project trends, issues and other relevant activities.
- Strong knowledge of drug development process and FDA IND/NDA requirements.
- Understanding of clinical trial regulations including FDA and GDPR 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.
- 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.
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