Senior Clinical Research Associate

BeiGene

Remote
Fully remote
Ich guidelines and gcp
Clinical monitoring activities
Site selection and evaluation
CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs

Job Summary

  • CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs.
  • CRA is responsible for collaborating closely with the Country and Regional Clinical Study Teams to ensure study timelines are adhered to and required quality standards are maintained.
  • Mentor junior staff (Associate CRA and CRA) and act as the escalation point person for CRA(s) with site-related issues and concerns.

Matching Summary

CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs.

Skills & Requirements

Must-have

  • ICH guidelines and GCP
  • clinical monitoring activities
  • site selection and evaluation
  • protocol and study training
  • monitoring visit reporting
  • site file maintenance

Nice-to-have

  • collaborative spirit
  • driving excellence
  • bold ingenuity
  • patients first
  • continuous learning
  • entrepreneurial mindset

Key Requirements

  • 3-5 years of monitoring experience
  • BS in a scientific or healthcare discipline
  • experience in oncology/onco-hematology global trials
  • Advanced knowledge of applicable clinical research regulatory requirements

Work Rights

Not specified

Tailored Resume

Cover Letter