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Clinical Document Specialist
2 weeks ago
Job Opportunity
Clinical Research Associate
About the Role:
As a Clinical Research Associate, you will be responsible for preparing and analyzing clinical trial documents. You will collaborate closely with key stakeholders to create, validate, and refine prompts for AI-assisted document generation.
Key Responsibilities:
- Prepare and analyze clinical trial documents.
- Work with various clinical documents: Protocol, Informed Consent Form, Clinical Study Report, Summary of Clinical Safety/Efficacy, Access Evidence Dossier, Statistical Analysis Plan, and more.
- Create, 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 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.
Requirements:
- Bachelor's degree in Life Sciences or related field.
- Experience in clinical research or a related field.
- Strong communication and collaboration skills.
- Ability to work independently and as part of a team.
- Proficiency in Microsoft Office and Google Suite.
- Knowledge of clinical trial regulations and guidelines.
- Ability to learn and adapt to new technologies.
Benefits:
This is an exciting opportunity to join our team and contribute to the success of our projects. We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.
How to Apply:
If you are a motivated and detail-oriented individual who is passionate about clinical research, we encourage you to apply for this role. Please submit your resume and a cover letter outlining your qualifications and experience.
