Summary
Overview
Work History
Education
Skills
ADDITIONAL EXPERIENCE
Accomplishments
CONFERENCE
ACTIVITIES & WORKSHOPS
Interests
Timeline
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ANUJA KUNDUKATTIL

Carlingford,NSW

Summary

Motivated and detail-oriented Industrial Pharmacy Graduate with hands on experience in clinical research operations through internships from a global Clinical Research Organisation(PSI CRO). Demonstrated expertise in Investigator Site File(ISF) management, site initiation and closeout activities across multiple study phases. Proficient in industry-standard systems including Veeva, Site Doc, Site room and PRIMA with a solid understanding of GCP and regulatory documentation processes. Now seeking a full-time opportunity to contribute to clinical development, pharmacovigilance or research operations with a dynamic pharmaceutical or health care organisation.

Overview

2
2
years of professional experience

Work History

Site Management Associate Intern(CTA)

PSI CRO
02.2025 - 06.2025
  • Supported 3 clinical trials: 2 Phase III (New Zealand & Australia) and 1 Phase II (Australia)
  • Participated in 2 Site Initiation Visits and 1 Remote Monitoring Visit with CRAs
  • Managed study documentation on SharePoint for internal and regional teams
  • Communicated with Regional Project Coordinators and assisted in CSR distribution
  • Maintained and filed documents in eTMF and Site Room; updated TMF checklists
  • Assembled ISFs, Pharmacy Binders, and prepared Deed of Transfer documents
  • Created site teams in CTMS and coordinated study shipments
  • Documented meeting minutes and resolved document-related queries

Clinical Operations Administrative Support

PSI CRO
07.2024 - 11.2024
  • Assembled and printed ISFs and Pharmacy Binders for clinical sites
  • Supported preparation and coordination of site shipments
  • Attended internal team trainings and clinical operations meetings
  • Documented meeting minutes and assisted in tracking follow-ups
  • Performed quality checks on trial-related documents
  • Filed and organized regulatory and operational documents in the TMF
  • Contributed to general administrative support across multiple clinical studies

Pharmacy Intern

PK DAS HOSPITAL
01.2023 - 03.2023
  • Efficiently managed a range of responsibilities, including prescription verification, medication dispensing, and patient counselling, to ensure optimal patient care.
  • Demonstrated expertise in maintaining medical records, monitoring drug expiration dates, and reviewing previous pharmacy reports to enhance medication safety and quality.
  • Performed additional duties such as inventory management, sterile compounding, and assisting with regulatory compliance.

Education

Master of Pharmaceutical Industry Practice -

The University of Queensland
Brisbane, QLD
07-2025

Bachelor of Pharmacy -

Rajiv Gandhi University of Health Sciences
11.2022

Skills

  • Clinical Trial Support & documentation (TMF, ISF, binders)
  • Proficiency in Document Managements Systems(CTMS, PRIMA, Site Room, Site Doc, Veeva)
  • Regulatory Compliance
  • eCRF data entry (Medidata Rave)
  • Knowledge of ICH-GCP & SOP compliance
  • Query tracking and resolution
  • Handling of Single and Double beam UV Spectrophotometer
  • Technical Proficiency in MS Office(Word, Excel, Power-Point)
  • Strong attention to detail & data accuracy
  • Good communication & time management
  • Experience supporting monitoring visits
  • Flexible with timelines and workloads

ADDITIONAL EXPERIENCE

Duty Supervisor
Sanchurro, Glebe NSW
July 2024 – Present

  • Prepared staff rosters, managed stock ordering, and trained new team members
  • Oversaw daily operations ensuring smooth workflow and quality standards

Crew Member
Hungry Jack’s, Herston Brisbane
Oct 2023 – June 2024

  • Delivered exceptional customer service, addressing inquiries and coordinating with kitchen staff
  • Managed multiple tasks including order taking and payment processing efficiently

Team Member
Red Rooster, Kelvin Grove Brisbane
Sept 2023 – June 2024

  • Collaborated with kitchen staff to ensure smooth operations and high-quality food delivery
  • Maintained strict food safety and sanitation standards

Team Member
McDonald’s, Kangaroo Point Brisbane
July 2023 – Sept 2023

  • Thrived in fast-paced environment managing multiple responsibilities during busy shifts
  • Developed strong communication and teamwork skills

Accomplishments

  • Good Clinical Practice(GCP) Training V.1
  • ICH Good Clinical Practice E6 R2
  • Good Laboratory Practice Certificate
  • Registered Pharmacist Certificate from Pharmacy Council, India
  • Ethics and Best Practices In Sharing Individual Level Research Data
  • Ethics of Ancillary Care In Research
  • Dean's Commendation for Academic Excellence
  • National Conference on 'Conversations of the Clinical Pharmacist'- OSCE
  • Introduction to Clinical Research
  • Introduction to Collecting and Reporting Adverse Events in Clinical Research
  • Data Safety and Monitoring Boards for Clinical Trials
  • Clinical Research Operations for Study Coordinators

CONFERENCE

  • National Conference on “Conversations of the Clinical Pharmacist - Objective Structured Clinical Evaluation,” 25 February 2019
  • National Conference on “Consortium on Modern Tools and Techniques for Drug-Design and Discovery — A Paradigm Shift,” 16 April 2022

ACTIVITIES & WORKSHOPS

  • Participated in workshop on Handling of HPLC and UV Spectrophotometer
  • Attended webinars on Vascular Effects of COVID-19 (Sep 2020) and Breast Cancer Awareness (Oct 2020)
  • Hosted cultural activities, science exhibitions, conferences, and workshops
  • Participated in dance events at college
  • Worked as a COVID-19 awareness volunteer

Interests

  • Reading
  • Music
  • Walking
  • Travelling
  • Gaming

Timeline

Site Management Associate Intern(CTA)

PSI CRO
02.2025 - 06.2025

Clinical Operations Administrative Support

PSI CRO
07.2024 - 11.2024

Pharmacy Intern

PK DAS HOSPITAL
01.2023 - 03.2023

Master of Pharmaceutical Industry Practice -

The University of Queensland

Bachelor of Pharmacy -

Rajiv Gandhi University of Health Sciences
ANUJA KUNDUKATTIL