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Clinical Document Specialist
2 weeks ago
About the Position:
As a key professional in clinical research, you will be responsible for crafting and analyzing documents related to clinical trials.
The ideal candidate should possess 1-5 years of experience in this field and hold any graduation degree. You will work with critical clinical documents, including protocols, informed consent forms, and clinical study reports.
You will develop, validate, and refine prompts for AI-assisted document generation, apply knowledge of clinical trial phases, study design, and drug development.
Maintain compliance with global regulatory standards (FDA, EMA, ICH-GCP), utilize medical terminologies and ontologies for clarity and consistency.
Ensure quality control and timely delivery of assigned tasks, collaborate with cross-functional teams to improve document accuracy and prompt effectiveness.
Provide regular updates and flag risks to the project manager.
- Create and analyze clinical trial documents.
- Develop, validate, and refine prompts for AI-assisted document generation.
- Apply knowledge of clinical trial phases, study design, and drug development.
- Maintain compliance with global regulatory standards.
- Utilize medical terminologies and ontologies.
- Ensure quality control and timely delivery of tasks.
- Collaborate with cross-functional teams.
- Provide regular updates and flag risks.