Clinical Research Associate

Added
8 days ago
Type
Full time
Salary
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Related skills

gcp clinical research ich guidelines oncology sops

πŸ“‹ Description

  • Monitor activities conducted by clinical investigative sites in support of AbbVie clinical studies
  • Ensure adherence to federal and applicable local regulations, Good Clinical Practice (GCP), ICH
  • Conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase 1–4
  • Oversee the activities of site personnel, despite having no direct authority, and motivate and
  • Proactively manage assigned sites and ensure that appropriate action plans are implemented as
  • Ensure regulatory inspection readiness at assigned clinical sites.

🎯 Requirements

  • Appropriate tertiary qualification; a health-related degree or background, such as Medicine, Life
  • Minimum of 1 to 2 years of experience as a CRA at a pharmaceutical company or CRO. Candidates with
  • Experience conducting on-site monitoring of investigational drug or medical device trials is
  • Current, in-depth knowledge and understanding of relevant therapeutic indications as they relate to
  • Current, in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines, and
  • Strong planning and organizational skills, with the ability to work effectively and efficiently in
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