PRASUN CHAKRABORTY
Bangalore
Summary
Dedicated Clinical Research Coordinator experienced in complying with study protocols, standard operating procedures and good clinical practices. Practiced problem-solver with strong attention to detail. Prepared to offer 3 years' experience in the field and take on a fast-paced position.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Sr Clinical Trail Associate
Aurigene Oncology Limited
Bangalore
06.2025 - Current
- Coordinated with CRAs to ensure accuracy of source documentation, adverse event reporting and resolution of queries.
- Reviewed statistical analysis plans for adherence to regulatory requirements and study protocols.
- Participated in periodic audits conducted by sponsors or regulatory agencies.
- Provided guidance on monitoring activities to internal stakeholders, including Clinical Research Associates, Data Management personnel, and Clinical Scientists.
- Prepared monthly status reports detailing progress against key milestones across multiple studies.
- Managed the communication between internal teams regarding central monitoring matters.
- Compiled weekly summary reports summarizing patient enrollment, site visits, and query resolution across all studies within the program portfolio.
Clinical Trial Associate
Aurigene Oncology Limited
Bangalore
06.2022 - 05.2025
- As a Clinical Trial associate one of the primary activity is to perform all study related start-up activities such as Collecting essential documents during site feasibility check, preparing EC dossier and site-master file during site activation stage.
- Developed and maintained trial master files in accordance with GCP and ICH guidelines.
- Created and managed clinical trial databases, including data entry of source documents into the database.
- Performed reconciliation between source documents and database entries to ensure accuracy of information.
- Provided support to Clinical Research Associates on site monitoring activities as co-monitor.
- Prepared reports summarizing study progress from inception through closure.
- Coordinated shipping of investigational products to investigative sites according to protocol requirements.
- Tracked enrollment status of patients in clinical trials.
- Reviewed and tracked adverse events reported by investigators.
- Organized meetings with sponsors and investigators regarding protocol amendments or any changes required during the course of a study.
- Communicated effectively with external stakeholders such as sponsors, CROs, vendors.
- Participated in feasibility assessments for new studies.
- Responded to queries from internal stakeholders regarding study progress or results.
- Interacted with vendors regarding equipment maintenance or troubleshooting issues.
- Maintained tracking systems for investigator payments, regulatory documents, and other study related materials.
Clinical Trial Assistant
MEDCLIN RESEARCH PVT. LTD
Kolkata
06.2021 - 06.2022
- Conducted site visits to monitor study progress, assess compliance with protocol, and review source documentation.
- Collaborated with internal teams on project timelines and deliverables.
- Tracked subject enrollment status, screening results, adverse events, concomitant medications.
- Maintained regulatory documents such as informed consent forms and investigator brochures.
- Monitored drug supplies at investigative sites to ensure adequate supply throughout the duration of the trial.
- Prepared submissions for Institutional Review Board or Ethics Committee approval, amendments, renewals.
- Maintaining Trial Master file.
Education
Post Graduate Diploma - Clinical Research Grades
Technobridge
Pune05.2021
M. sc - Biotechnology
Chandigarh University
Chandigarh04.2020
B. sc(H) - Microbiology
Maulana Abul Kalam Azad University Of Technology
West Bengal05.2018
12th Class -
WBCHSE
West-Bengal2015
10th Class -
WBBSE
West-Bengal2013
Skills
- Trial Oversight
- Documentation Requirements, Good Documentation Practice
- Job role oriented mid-level proficiency in MS Excel and other MS Office tools and other electronic systems
- Professional knowledge in the field of Clinical research involving ICH guidelines, GCP, clinical trials, SAEs, etc
- Study coordination
- Regulatory Submissions
Languages
Bengali
First Language
English
Upper Intermediate
B2
Hindi
Upper Intermediate
B2
Certification
- Good Clinical Practice (NIDA clinical Coordinating center)
Declaration
- I hearby declare that all above-mentioned informations are in accordance with the fact or true up to my knowledge and I bear responsibilities for the correctness of above mentioned particulars.
Timeline
Sr Clinical Trail Associate
Aurigene Oncology Limited
06.2025 - Current
Clinical Trial Associate
Aurigene Oncology Limited
06.2022 - 05.2025
Clinical Trial Assistant
MEDCLIN RESEARCH PVT. LTD
06.2021 - 06.2022
Post Graduate Diploma - Clinical Research Grades
Technobridge
M. sc - Biotechnology
Chandigarh University
B. sc(H) - Microbiology
Maulana Abul Kalam Azad University Of Technology
12th Class -
WBCHSE
10th Class -
WBBSE
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