Clinical Research Associate

Junior Role (1 - 5 years)

Locations : Delhi

1 year renewable contract

Job Responsibilities:

Mandatory : author protocol , informed concent form (ICF) and clinical summary report (CSR)

1) Author and analyze clinical trial documents.

2 )Work with key clinical documents: Protocol, Informed Consent Form, Clinical Study Report,

3) Summary of Clinical Safety/Efficacy, Access Evidence Dossier, Statistical Analysis Plan and more.

4) Create, validate, and refine prompts for AI-assisted document generation.

5 )Apply knowledge of clinical trial phases, study design, and drug development.

6 )Maintain compliance with global regulatory standards (FDA, EMA, ICH-GCP).

7) Ensure quality control and timely delivery of assigned tasks.

8) Collaborate with cross-functional teams to improve document accuracy and prompt effectiveness.

9) Provide regular updates and flag risks to the project manager.