Summary
Overview
Work History
Education
Skills
APC Certificate
Certification
Languages
Work Preference
Work Availability
Interests
Timeline
Generic

Shazia Inayath Khatoon

FAWKNER,Victoria

Summary

Results-driven Clinical Research Coordinator with extensive experience managing Phase 2-4 clinical trials within CRO environments. Skilled in end-to-end trial coordination, protocol compliance, and multi-site study oversight. Proven ability to manage multiple concurrent studies while ensuring regulatory adherence, data quality, and timely deliverables. Strong communicator adept at fostering collaboration across sponsors, investigators, and internal teams. Recently passed the KAPS exam (Nov 2024), bringing up-to-date regulatory and pharmaceutical knowledge and readiness to contribute in a dynamic, fast-paced CRO setting.

Overview

6
6
years of professional experience
1
1
Certification

Work History

Clinical Research Coordinator

Osmania General Hospital
12.2021 - 11.2023
  • - Coordinated and managed multiple clinical trials from initiation to close-out.
  • - Recruited and screened study participants, obtained informed consent, and ensured eligibility.
  • - Collected, recorded, and maintained accurate study data in electronic data capture (EDC) systems.
  • - Monitored participant safety and reported adverse events in compliance with regulatory guidelines.
  • - Liaised with investigators, study sponsors, and regulatory bodies to facilitate study progress.
  • - Conducted study visits, including patient assessments, sample collection, and administration of study interventions.
  • - Prepared and submitted regulatory documents, including IRB submissions and amendments.
  • - Managed study budgets, tracked expenses, and ensured financial compliance.

Clinical Pharmacist (Part-Time)

Naseeb Clinic
04.2021 - 11.2021
  • - Developed, implemented, and monitored medication-use systems.
  • - Educated the public about safe and effective medication use.
  • - Provided direct patient care services such as medication reviews, therapeutic drug monitoring, and patient education.
  • - Prescribed and informed patients on medication usage and monitored patient progress.
  • - Advised and counseled patients on the proper use of their medications.

Clinical Pharmacist

Asia Hospitals
04.2020 - 02.2021
  • - Provided comprehensive pharmaceutical care services in an acute care setting.
  • - Performed medication therapy management services, including medication reconciliation, order reviews, and patient education.
  • - Collaborated with healthcare professionals to ensure the safe and effective use of medications.
  • - Managed drug formulary maintenance, medication procurement, and storage.
  • - Identified and resolved potential and actual drug-related problems to optimize therapeutic outcomes.

Clinical Research Assistant (Part-Time)

FS Clinical Trials
01.2018 - 05.2019
  • - Supported the coordination and management of clinical trials.
  • - Assisted in patient recruitment, screening, and enrollment processes.
  • - Maintained and updated study documentation, including source documents and regulatory binders.
  • - Conducted data entry and ensured data accuracy and integrity.
  • - Assisted in the preparation and submission of IRB and regulatory documents.

Education

Doctor of Pharmacy - Pharmacy

MRM College of Pharmacy, Jawaharlal Nehru Technological University
Hyderabad, Telangana
01.2020

Skills

  • - Leadership skills
  • - Good Clinical Practice (GCP) & Good Manufacturing Practice (GMP)
  • - FDA, ICH, and Ethics Committee regulations compliance
  • - HIPPA Compliant clinical practice
  • - Knowledge of disease processes and clinical research compounds
  • - Drug and device development processes
  • - Medical Data Coding (MedDRA, WHO-Drug) and Narratives Writing for ICSRs
  • - Aggregate Medical Reporting and analytical skills
  • - Quality Compliance & Due Diligence (QC)
  • - Standard Process Design (SOPs, Checklists), CTMS
  • - Excellent Interpersonal Skills (Detail-Oriented, Organized, Creative Problem Solving)
  • - Safety Management (AE/AESI, ADR, SAE, SUSAR, CIOMS, ICH, EMA)
  • - Knowledge of 21 CFR parts 11, 50, 54, 56, 312
  • - Excellent Computer Skills (Jarvis, Red Cap, RAVE EDC, J-review, Inform, PowerPoint, elluminate, Word, Excel, Veeva vault, Share drive, OneNote, Argus, Clinspark, Smartsheet, Outlook)
  • - Clinical Trials, Clinical Development, Analytics, User Acceptance Testing, Quality Assurance, Quality Audits

APC Certificate

KAPS Paper 1 pass November 2024

KAPS Paper 2 pass November 2024

Certification

  • - Good Clinical Practice (NIDA Clinical Trial Network, 2021)
  • - Good Clinical Practice (Global Health, 2021)
  • - Introduction to Protocol (Global Health, 2021)
  • - Informed Consent Form (Global Health, 2021)
  • - Introduction to Collecting and Reporting Adverse Events (Global Health, 2021)
  • - Data Safety and Monitoring Board for Clinical Trials (2021)

Languages

English
Advanced (C1)
Urdu
Bilingual or Proficient (C2)

Work Preference

Work Type

Full Time

Work Location

Hybrid

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Interests

ARTS

Socialising

Exploring

Timeline

Clinical Research Coordinator

Osmania General Hospital
12.2021 - 11.2023

Clinical Pharmacist (Part-Time)

Naseeb Clinic
04.2021 - 11.2021

Clinical Pharmacist

Asia Hospitals
04.2020 - 02.2021

Clinical Research Assistant (Part-Time)

FS Clinical Trials
01.2018 - 05.2019

Doctor of Pharmacy - Pharmacy

MRM College of Pharmacy, Jawaharlal Nehru Technological University

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Shazia Inayath Khatoon