
Senior Clinical Documentation Specialist
2 days ago
About the Role:
We are seeking a skilled Clinical Research Associate to join our organization. In this position, you will be responsible for creating and analyzing clinical trial documents.
Key Responsibilities:
- Create and analyze clinical trial documents.
- Work with key clinical documents: Protocol, Informed Consent Form, Clinical Study Report, Summary of Clinical Safety/Efficacy, Access Evidence Dossier, Statistical Analysis Plan, and more.
- 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.
The ideal candidate will have 1-5 years of experience in a similar role and any graduation degree. They should be proficient in working with flexible schedules and possess excellent communication skills.
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