Study Start-up Clinical Research Associate

Novartis UK

United Kingdom
3 years clinical operations experience
Site selection and eligibility verification
Irb/iec and health authority submissions
The Study Start-Up CRA is accountable for site selections and ensuring sustainable trial start-up at assigned sites for Phase I-IV GDD trials

Job Summary

  • The Study Start-Up CRA is accountable for site selections and ensuring sustainable trial start-up at assigned sites for Phase I-IV GDD trials.
  • This role serves as the main contact for trial sites during site selection, study start-up, and IRB/IEC submission preparation while managing timelines and deliverables.
  • The position requires proactive site preparation, early identification of issues, and a close handover to execution CRAs to ensure inspection readiness.

Matching Summary

The Study Start-Up CRA is accountable for site selections and ensuring sustainable trial start-up at assigned sites for Phase I-IV GDD trials.

Skills & Requirements

Must-have

  • 3 years clinical operations experience
  • Site selection and eligibility verification
  • IRB/IEC and Health Authority submissions
  • ICH/GCP and local regulation adherence
  • Study start-up timeline management

Nice-to-have

  • Strong negotiation and problem-solving skills
  • Central or in-house monitoring experience
  • International drug development knowledge
  • Fast change adaptability and influence
  • Trust and rapport building with sites

Key Requirements

  • Degree in scientific or health discipline
  • Minimum 3 years clinical operations experience
  • Fluent in written and spoken English

Work Rights

Not specified

Tailored Resume

Cover Letter