Initiation Clinical Research Associate II
HyderabadFull-time3–6 yrsPosted over a month ago
Mid-level pharma role at Parexel International India safety services in Hyderabad. Needs 3+ years and a degree.
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
- Clinical research
- PowerPoint
- Regulatory affairs
- Documentation
- Communication