Chandrali Gogoi
Clinical Research Associate
Delhi
Summary
Clinical Research Associate with 6+ years of experience in clinical trial execution, site monitoring, and regulatory compliance across observational and interventional studies. Proven expertise in managing registries, coordinating with Principal Investigators, and ensuring ICH-GCP, NDCT (2019), and Indian GCP compliance. Adept at remote and onsite monitoring, site start-up, feasibility assessments, and eTMF management with a strong focus on audit readiness and CAPA implementation
Overview
6
6
years of professional experience
6
6
years of post-secondary education
Work History
Senior Executive - Clinical Research Associate
Sun Pharmaceuticals Industries Limited
03.2024 - Current
- Led feasibility and start-up activities for multi-site studies, including rare disease registries.
- Coordinated IRB/EC submissions, customized ICFs, and managed site contracts and budgets.
- Conducted remote and onsite monitoring visits, ensuring protocol adherence and data quality.
- Maintained eTMF and CTMS documentation for audit readiness and inspection preparedness.
- Liaised with vendors and site staff to ensure timely recruitment and study progress updates.
Quality Manager
Clinical Development Services Agency, THSTI
06.2023 - 03.2024
- Implemented CAPA and risk-based assessments to enhance site-level compliance.
- Conducted source document verification and trained site staff on GCP and documentation standards.
- Supported monitoring visits and ensured resolution of quality issues across registry sites.
Clinical Research Associate
Clinical Development Services Agency, THSTI
09.2021 - 06.2023
- Managed registry-based observational studies, including a large pregnancy cohort across multiple sites.
- Performed eCRF reviews, SDV, and query resolution in collaboration with data management teams.
- Oversaw IP inventory, trial supplies, and regulatory documentation with 100% accuracy.
- Trained site staff on protocol-specific documentation and compliance practices.
Clinical Research Assistant
Translational Health Science and Technology Institute
07.2019 - 09.2021
- Supported site investigators in trial management and regulatory submissions.
- Maintained regulatory binders, source documents, and case report forms.
Education
Post Graduate Diploma - Clinical Research
Institute of Good Manufacturing Practices Noida
Noida, UP 01.2018 - 01.2019
Master of Science - Molecular Biology and Biotechnology
Tezpur University
01.2015 - 01.2017
Bachelor of Science - Zoology
Cotton College, Guwahati University
01.2012 - 01.2015
Skills
Site Management & Monitoring: Remote/Onsite Visits, Site Initiation, Closeout, Patient Recruitment
Timeline
Senior Executive - Clinical Research Associate
Sun Pharmaceuticals Industries Limited
03.2024 - Current
Quality Manager
Clinical Development Services Agency, THSTI
06.2023 - 03.2024
Clinical Research Associate
Clinical Development Services Agency, THSTI
09.2021 - 06.2023
Clinical Research Assistant
Translational Health Science and Technology Institute
07.2019 - 09.2021
Post Graduate Diploma - Clinical Research
Institute of Good Manufacturing Practices Noida
01.2018 - 01.2019
Master of Science - Molecular Biology and Biotechnology
Tezpur University
01.2015 - 01.2017
Bachelor of Science - Zoology
Cotton College, Guwahati University
01.2012 - 01.2015
Similar Profiles
Ankit SharmaAnkit Sharma
Project Manager, PMO at Sun Pharmaceuticals Industries LimitedProject Manager, PMO at Sun Pharmaceuticals Industries Limited
SIVAPRAKASH KPSIVAPRAKASH KP
Regional Sales Manager at Sun Pharmaceuticals industries limitedRegional Sales Manager at Sun Pharmaceuticals industries limited
RAJESH KUMARRAJESH KUMAR
Sr. Executive at Sun Pharmaceuticals Industries LimitedSr. Executive at Sun Pharmaceuticals Industries Limited
Saksham MauryaSaksham Maurya
DevOps Solution Architect – Assistant Consultant at Tata Consultancy ServicesDevOps Solution Architect – Assistant Consultant at Tata Consultancy Services
JITENDRA JANGIDJITENDRA JANGID
Assistant Manager - Consulting & Analytics at ICICI Lombard General Insurance CoAssistant Manager - Consulting & Analytics at ICICI Lombard General Insurance Co