Summary
Overview
Work History
Education
Skills
Languages
Websites
Certification
Declaration
Timeline
Generic
PRASUN CHAKRABORTY

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
Pune
05.2021

M. sc - Biotechnology

Chandigarh University
Chandigarh
04.2020

B. sc(H) - Microbiology

Maulana Abul Kalam Azad University Of Technology
West Bengal
05.2018

12th Class -

WBCHSE
West-Bengal
2015

10th Class -

WBBSE
West-Bengal
2013

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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PRASUN CHAKRABORTY