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Initiation Clinical Research Associate II

Parexel International India safety services·Hyderabad

Pay not stated3–6 yrsFull-time

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About the role

We are seeking an Initiation Clinical Research Associate II (Site Start Up EUCTR II) to join our team in a Hybrid capacity at our Hyderabad office. As an Initiation Clinical Research Associate II, you will support complex clinical trial initiation activities that advance new treatments for patients.

What you'll do

  • Collaborate with Clinical Trial Management and Regulatory Affairs teams to develop comprehensive study startup strategies
  • Plan and execute complex EU Clinical Trial Application (CTA) submissions for Part II trials
  • Identify and manage participating Member States, institutions, and Primary Investigators
  • Collect, organize, and upload applicable Member State and site-level documents for CTA submissions
  • Monitor and report on Part II CTA progress against trial timelines, identifying risks and ensuring alignment with overall study objectives and regulatory milestones

What you need

  • 3–6 yrs of experience
  • Clinical research
  • PowerPoint
  • Regulatory affairs
  • Documentation
  • Communication
  • Any graduate

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