Study Start-up Clinical Research Associate

Novartis UK

United Kingdom
On-site
Site selection and start-up activities
Phase i-iv gdd trials
Ich/gcp and local regulations
Novartis UK is seeking a Study Start-up Clinical Research Associate to manage site relationships and ensure effective trial start-up for Phase I-IV clinical trials. The ideal candidate should have a scientific background, significant clinical operations experience, and strong interpersonal skills

Job Summary

  • The Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV GDD trials within the country.
  • Proactive site preparation and early identification of real site needs and issues and close handover to execution CRA for all sites is key.
  • Ensures timelines, accuracy, and quality of country and site TMF documents in study start-up to ensure TMF inspection readiness.

Matching Summary

Match Score: 85

Novartis UK is seeking a Study Start-up Clinical Research Associate to manage site relationships and ensure effective trial start-up for Phase I-IV clinical trials. The ideal candidate should have a scientific background, significant clinical operations experience, and strong interpersonal skills.

Skills & Requirements

Must-have

  • Site selection and start-up activities
  • Phase I-IV GDD trials
  • ICH/GCP and local regulations
  • Site relationship management
  • Timely study start-up
  • Collection of site-specific documents

Nice-to-have

  • Innovative and efficient processes
  • Trust and rapport building
  • Fast change adaptability
  • Negotiating and problem-solving skills
  • Interpersonal and communication skills

Key Requirements

  • Degree in scientific or health discipline
  • Minimum 3 years' experience in clinical operations
  • Fluent in written and spoken English
  • Advanced understanding of clinical drug development

Work Rights

Not specified

Tailored Resume

Cover Letter