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
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