
Document Author Specialist
2 days ago
Clinical Research Associate
About this role:
We are seeking a skilled Clinical Document Author to join our team. As a key member of our clinical operations group, you will be responsible for authoring and analyzing clinical trial documents to ensure compliance with global regulatory standards.
- Author and analyze clinical trial documents to ensure compliance with global regulatory standards (FDA, EMA, ICH-GCP).
- Work with key clinical documents, such as Protocol, Informed Consent Form, Clinical Study Report, Summary of Clinical Safety/Efficacy, Access Evidence Dossier, Statistical Analysis Plan, and more.
- Develop and refine prompts for AI-assisted document generation to improve document accuracy and prompt effectiveness.
- Stay up-to-date with clinical trial phases, study design, and drug development to apply medical terminologies and ontologies for clarity and consistency.
- Collaborate with cross-functional teams to ensure quality control and timely delivery of assigned tasks.
Key qualifications for this role include:
- Strong understanding of clinical trial documentation and regulatory requirements.
- Excellent writing and analytical skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Proficiency in using technology to enhance workflow efficiency.
- Detail-oriented with a strong focus on quality and accuracy.
This is an exciting opportunity to contribute to the success of our clinical operations team and help shape the future of clinical research.
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