Summary
Overview
Work History
Education
Skills
LANGUAGES
INTERNSHIP AND CERTIFICATIONS
EXTRACURRICULAR ACTIVITIES
Timeline
Generic

CHETHAN RE

Bengaluru

Summary

As an accomplished Clinical Trial Assitant, I bring in around 4 years of experience in Clinical Trials with in-depth knowledge of Clinical Trial Management System (CTMS), Clinical Research Practices, applicable standards viz., ICH - GCP, GLP guidelines, FDA guidelines, Drug Regulatory Affairs, SOW / SOP and Quality Assurance procedure ensuring compliance with industry standards. My expertise lies in strategic planning, document preparation, site activation and maintenance, and cross-functional collaboration. I thrive in dynamic environments, driving successful submissions and approvals.

Overview

5
5
years of professional experience

Work History

Clinical Trial Assistant

ICON Plc - FSP Pfizer
Bengaluru
03.2025 - Current
  • Manage the transfer of eISF ownership to study sites, ensuring sites have proper access and document management.
  • Create and manage electronic Investigator Site Files (eISF), compiling required documents and transferring them to sites before Site Initiation Visits (SIVs). Create and forward the site activation updates mail regarding trainings
  • Handle document translations at the country or site level, ensuring compliance with local language and regulatory requirements.
  • Track and manage hardcopy financial disclosure Forms (FDF), ensuring accurate records and timely updates.
  • File rater training and certification records in the Trial Master File (TMF), ensuring sites meet regulatory requirements for training compliance. Send site selection correspondence (Selected/Not Selected Letters) to relevant sites and customize ISF logs to align with the unique requirements of each study site.
  • Oversee insurance records, ensuring country-specific insurance compliance and managing updates or renewals as needed.
  • Coordinate local printing and shipping tasks, including printing approved Emergency Cards and distributing them to study sites.
  • Onboard and support CTAs globally, providing 12 weeks of training and guidance to ensure they are integrated and fully prepared for their roles.
  • Confirm site training and application access, following the site activation checklist to ensure readiness for study participation.

Centralized Monitoring Assistant

IQVIA
Bengaluru
03.2021 - 03.2024
  • Manage the payment related tasks such as Invoice reviewing, cross-checking the visits mentioned against the EDC visit dates, approval of the payment batches, communication with IPA teams.
  • Filing and archiving the study, country and site level documents in eTMF, SharePoint using File dropping / iTMF tool. Establish, maintain, and use appropriate team information repositories using eTMF.
  • Prepare the trackers such as SRtE Tracker, Q&A log, Compliance trackers, etc.
  • Export and analyze the reports such as Action Items report, CRA Visit reports, Protocol deviations report, etc using different platforms such as CTMS, ELVIS, Wingspan, EDC, etc
  • Support and partner with Centralized Monitoring Lead(s) and Clinical Lead to oversee maintenance and inspection readiness of study files including regular and pre inspection quality reviews, metadata information, indexing, associated updated versions.

Executive Pharmacist

Medplus
Bengaluru
12.2019 - 02.2021
  • Worked as a Pharmacist, hands-on experience on reading prescriptions and dispensing drugs accordingly
  • Auditing of drugs, billing and receiving medicines from main stock warehouse, customer handling and dispensing quality medicines, knowledge on medicine uses and classes.

Education

Bachelor of Science -

Nargund College of Pharmacy
Bengaluru
06-2019

Skills

  • Electronic data capture
  • Siebel CTMS
  • RAVE
  • Wingspan
  • CM Platform
  • Veva Vault
  • MS Excel
  • CorelDRAW
  • Photoshop
  • Pivot tables
  • eTMF
  • SIP

LANGUAGES

  • English
  • Kannada
  • Hindi
  • Telugu
  • Tamil

INTERNSHIP AND CERTIFICATIONS

  • Completed an internship at Univa Medica, Bangalore, in the year 2019 During the Period, undergone training in Tablets section, Capsule sections, Liquid Oral section, Quality Control and Quality assurance and Packaging selection.
  • Completed certification on Certified Clinical Research Professional (CCRP).

EXTRACURRICULAR ACTIVITIES

  • I attended health camps conducted by NGOs and other local organizations.
  • Attended the International and national level Health conferences.
  • Represented the school and college teams in various sports events.

Timeline

Clinical Trial Assistant

ICON Plc - FSP Pfizer
03.2025 - Current

Centralized Monitoring Assistant

IQVIA
03.2021 - 03.2024

Executive Pharmacist

Medplus
12.2019 - 02.2021

Bachelor of Science -

Nargund College of Pharmacy

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