Clinical Project Assistant
Sanofi
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Job Description
Location: New Delhi, India
Job ID: R-238617
Company: AstraZeneca
Date Posted: 04 Nov 2025
Closing Date: 14 Nov 2025
About the Role
AstraZeneca is a global, science-led biopharmaceutical company committed to discovering, developing, and commercializing innovative medicines for some of the world’s most serious diseases. As a Clinical Research Associate (CRA 1), you will oversee and manage clinical trial sites to ensure quality, compliance, and operational excellence throughout all study phases.
This role places you at the heart of clinical research, supporting the advancement of life-changing medications while working in a diverse, collaborative, and growth-focused environment.
Role & Responsibilities
- Contribute to the selection and feasibility of potential investigators and clinical sites.
- Support study start-up and regulatory maintenance, including Site Qualification Visits, document collection, tracking, and EC/IRB/regulatory submissions.
- Train, support, and advise site staff on study-related processes and Risk-Based Quality Management (RbQM) principles.
- Ensure completion and documentation of all required ICH-GCP and study-specific training.
- Actively participate in Local Study Team (LST) meetings and national investigator meetings.
- Initiate, monitor, and close study sites per AstraZeneca SOPs and protocols.
- Drive site performance, proactively resolving issues and escalating when necessary.
- Update CTMS and other platforms with accurate site-level information.
- Manage study supplies, Investigational Product (IP) accountability, and preparation for destruction if applicable.
- Conduct remote and onsite monitoring visits, remote data checks, and determine visit timing as needed.
- Perform Source Data Review (SDR), Source Data Verification (SDV), and CRF reviews per Monitoring Plan.
Educational Qualification
- Bachelor’s degree in Life Sciences or a related field (required).
- Strong understanding of clinical research processes, methodologies, and regulations.
- In-depth knowledge of ICH-GCP and local regulatory guidelines.
- Practical understanding of clinical site operations and medical records.
- Strong organizational, analytical, and critical thinking skills.
- Excellent communication skills in English and local language.
- Ability to work independently with a proactive mindset and continuous learning attitude.
- Ability to manage multiple protocols across diverse therapeutic areas.
Location
New Delhi, India
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