Octalsoft,Oracle,Gaja,Clinion,Trial OS
Rupanwita Chakraborty
Clinical Research Coordinator
Kolkata,WB
Summary
Dedicated Clinical Research Professional with over 3 years of progressive experience in Clinical Research Coordination, Data Management, and Regulatory Affairs. Skilled in managing clinical trials from initiation to close-out in accordance with ICH-GCP guidelines and applicable regulatory requirements. Demonstrated expertise in participant recruitment, informed consent processes, data collection, SAE management, and regulatory submissions. Successfully faced DCGI inspections twice, showcasing strong preparedness and compliance under regulatory scrutiny. Highly organized and detail-oriented, with a proven commitment to data integrity and quality standards. Proficient in handling multiple EDC systems and patient safety documentation. Recognized for maintaining positive relationships with participants, sponsors, CRO teams, and investigators. A strong team collaborator with excellent problem-solving abilities and a continuous learning mindset to stay aligned with evolving clinical research and regulatory standards.
Overview
3
3
Languages
6
6
Certifications
3
3
years of professional experience
Work History
CLINICAL RESEARCH COORDINATOR
INDORIV/ CLINICAL PRIVATE LIMITED (SMO)
01.2025 - Current
- Successfully completed multiple oncology (cancer) studies, including BA/BE, Phase I, and Phase II trials, ensuring compliance with all regulatory and GCP requirements.
- Managed EDC systems with timely, accurate data entry, and source documentation.
- Effectively handled Serious Adverse Event (SAE) reporting, documentation processes, and on-time submission to regulatory authorities.
- Served as the primary coordinator for multiple studies simultaneously, coordinating site activities, and ensuring timely project deliverables.
- Coordinated study protocols and ensured compliance with regulatory requirements.
- Managed patient recruitment processes and maintained accurate subject records.
- Trained junior staff on best practices in clinical research methodologies and ethical standards.
- Developed and implemented standard operating procedures for efficient trial management.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
DATA MANAGEMENT ASSOCIATE for BE study
TAAB BIOSTUDY SERVICES (CRO)
02.2024 - 12.2024
- Performed daily data entry tasks, and managed databases for projects.
- Reviewed and evaluated regulatory documents to ensure compliance with applicable regulations.
- Ensured that all documentation is accurate before submitting it to regulatory authorities.
- PPT preparation and presentation in the SEC meeting.
CLINICAL RESEARCH COORDINATOR (INTERN)
Charaka Life Care (SMO)
07.2023 - 02.2024
- Coordinated patient recruitment and retention strategies for clinical trials.
- Followed informed consent processes and maintained records.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Oversaw the management of investigational product supplies, ensuring appropriate storage conditions were maintained at all times for optimal efficacy during trials.
- Developed strong relationships with trial sponsors, ensuring ongoing collaboration and future project opportunities.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Managed documentation for patient records, ensuring accuracy and compliance with regulatory standards.
Education
Post-Graduate Diploma - Clinical Research and Regulatory Affairs
Jadavpur University
01-2024
M.Sc. - Microbiology
Maulana Abul Kalam Azad University of Technology | Guru Nanak Institute of Pharmaceutical Science and Technology
01-2022
B.Sc. - Microbiology
University Of Calcutta Dinabandhu Andrews College
01-2020
undefined
West Bengal Council of Higher Secondary Education | Pareshnath Balika Bidyalaya
01-2017
undefined
West Bengal Board of Secondary Education | Jodhpur Park Girl's High School
01-2014
Skills
Painting
Singing
Photography
Octalsoft
Software
Certification
Completed Internship in the department of Haematology from Suraksha Diagnostics Pvt. Ltd.(13/12/2021 – 12/01/2022)
Timeline
CLINICAL RESEARCH COORDINATOR
INDORIV/ CLINICAL PRIVATE LIMITED (SMO)
01.2025 - Current
DATA MANAGEMENT ASSOCIATE for BE study
TAAB BIOSTUDY SERVICES (CRO)
02.2024 - 12.2024
CLINICAL RESEARCH COORDINATOR (INTERN)
Charaka Life Care (SMO)
07.2023 - 02.2024
undefined
West Bengal Board of Secondary Education | Jodhpur Park Girl's High School
undefined
West Bengal Council of Higher Secondary Education | Pareshnath Balika Bidyalaya
B.Sc. - Microbiology
University Of Calcutta Dinabandhu Andrews College
M.Sc. - Microbiology
Maulana Abul Kalam Azad University of Technology | Guru Nanak Institute of Pharmaceutical Science and Technology
Post-Graduate Diploma - Clinical Research and Regulatory Affairs
Jadavpur University
DECLARATION
The information provided is true to the best of my knowledge
LIST OF INDICATION
- Indication Phase Year
- MI Phase-III 2023
- HFrEF Phase-III 2024
- MDD Phase-III 2024
- CA OVARY BA-BE 2025
- AML BA-BE 2025
- TNBC Phase-II 2025
- CA OVARY BA-BE 2026