Anjali Thakar
Adelaide
Summary
Detail-oriented Clinical Research Associate with a background in Pharmacy and hands-on experience in clinical research support, documentation, and regulatory compliance. Skilled in maintaining Master Files, reviewing documentation, and assisting with study start-up to close-out activities. Familiar with ICH-GCP guidelines and clinical research standards. A proactive team player with strong communication and organizational skills.
Overview
3
3
years of professional experience
Work History
Quality Control
Axis Clinicals Limited
07.2022 - 06.2025
- Support all aspects of clinical operations from study start-up to completion.
- Organise and facilitate project/study team meetings; take accurate meeting minutes and follow-up actions.
- Prepare and maintain Trial Master Files (TMFs) and track completeness across the study lifecycle.
- Assist in preparation of Investigator Site Files (ISFs) and other essential study documentation.
- Liaise with cross-functional team members to maintain effective study communication.
- Collect, manage, and track site documentation from start-up to close-out in coordination with CRAs and Project Managers.
- Handle the shipment and receipt of study materials and documentation to and from Investigator sites.
- Maintain internal trackers and study-specific databases.
- Provide administrative and operational support for audits by sponsors or regulatory agencies.
- Assist in the documentation and reporting of Serious Adverse Events (SAEs) in line with protocol and GCP requirements.
- Perform other ad hoc clinical operations duties as required.
Education
Master of Pharmacy - Pharmaceutical Quality Assurance
Sharda School of Pharmacy
Pethapur, Gandhinagar01.2022
Bachelor of Pharmacy - undefined
Sharda School of Pharmacy
Pethapur, Gandhinagar01.2019
Skills
- Basic, MS Office, Internet
- Quality control standards
- Detailed documentation
- ICH guidelines
- Coordinating site operations
- Project monitoring
- Clinical trial management
- Clinical documentation
- Case report forms
Languages
English
Full Professional
Hindi
Native or Bilingual
Publications
- 1) GTU Techfest (zonal) – Pharma Poster
- 2) Pharma Vision 2017 – Poster
- 3) APP 7th Indo – Malaysian Conference – Poster
- 4) Gujarat Council on Science & Technology (GUJCOST) – Delegate
Training
I have successfully completed training in REDSON LABORATORIES PVT.LTD.
Disclaimer
I hereby declare that all the information given above is authentic to the best of my knowledge and if further information is required, I will be glad to furnish it. (ANJALI BHATT)
Timeline
Quality Control
Axis Clinicals Limited
07.2022 - 06.2025
Bachelor of Pharmacy - undefined
Sharda School of Pharmacy
Master of Pharmacy - Pharmaceutical Quality Assurance
Sharda School of Pharmacy
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