Clinical Trial Administrator

7 days ago


Brisbane, Queensland, Australia Parexel Full time

Parexel is committed to delivering exceptional results and exceeding client expectations.

Job Overview

The Clinical Trial Administrator - Study Operations Specialist will provide critical support to our Clinical Operations team, ensuring the successful execution of clinical trials. This role involves coordinating translations, managing trial documentation, and maintaining accurate records within our CTMS system.

Responsibilities

  • Coordinate translation activities, review translated documents, and submit for TMF filing.
  • Support CRA in preparing safety information submissions per site-specific requirements.
  • Maintain ISF (Investigator Site File) up-to-date, including paper ISF and binders.
  • Assist with organization and execution of investigator meetings.
  • Maintain study information in CTMS on behalf of the Clinical Trial Manager, running reports as needed.
  • Provide logistical support, organization, and coordination for internal and external meetings, trainings, and other events.
  • Process document archiving requests and financial disclosure requests according to SOPs.
  • Track CO clinical trial local disclosure KPIs and process end-user requests for system demonstrations.

Requirements

  • Bachelor's degree in nursing, pharmaceutical sciences, or a related field (preferred).
  • Strong organizational and communication skills.
  • Excellent understanding of Good Clinical Practice (GCP) and ICH-GCP.
  • Proficiency in Microsoft Office applications.
  • Ability to work collaboratively as part of a team, providing backup support when needed.
  • A minimum of 1 year of experience in the pharma industry or related field (desired).

What We Offer

  • An estimated salary range of $65,000-$80,000 based on location and experience.
  • Ongoing training and development opportunities to enhance your skills and knowledge.
  • A dynamic and supportive work environment that fosters collaboration and growth.

About Parexel

Parexel is a leading global biopharmaceutical services provider dedicated to supporting clients in accelerating their development goals.



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