Senior Clinical Trial Associate

3 weeks ago

Brisbane, Queensland, Australia Pharmiweb Full time

Job Summary

We are seeking a highly skilled Senior Clinical Trial Associate to join our team at Pharmiweb. As a Senior Clinical Trial Associate, you will play a key role in the coordination and administration of clinical trials from start-up to execution and close-out.

Key Responsibilities

  • Collect and track documents for the application process, as well as coordinate and track study materials and equipment.
  • Assist in the submission of proper applications/documents to EC/IRB and, where appropriate, to Regulatory Authorities.
  • Interface with Investigators, external service providers, and CRAs during the document collection process.
  • Local administrative main contact and work closely with CRAs and/or LSAD for the duration of the study.
  • Set-up and maintenance of the local eTMF and ISF, including document tracking in accordance with ICH-GCP and local requirements.
  • Ensure essential documents are uploaded in a timely manner to maintain the eTMF "Inspection Readiness" and study documents are ready for final archiving and completion of local part of the eTMF and support the CRA in the close-out activities for the ISF.
  • Prepare and/or support contract preparation at a site level (with the exception of countries where there is a specific role dedicated to preparing site contracts).
  • Lead the practical arrangements and contribute to the preparation of internal and external meetings. Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study/country related emails.
  • Interface with Data Management Centre and/or Data Management, Global Clinical Solutions representatives to facilitate the delivery of study-related documents/material.
  • Ensure compliance with local, national, and regional legislation, as applicable.

Requirements

  • Bachelor/Master degree.
  • At least two years of experience as CTA in CRO or Pharmaceutical Company (mandatory).
  • Excellent planning/organizational skills.
  • Problem-solving attitude.
  • Strong team player.

About Us

At Pharmiweb, we offer a comprehensive and competitive total reward package that comprises an excellent level of base pay, as well as a wide range of variable pay and recognition programs. Our best-in-class employee benefits, supportive policies, and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now and into the future.

We are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development. ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment.

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