Clinical Research Associate

Added
22 days ago
Type
Full time
Salary
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Related skills

gcp clinical research clinical trial management regulatory compliance risk-based monitoring
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πŸ“‹ Description

  • Considered as the Primary Sponsor Point of contact for the investigative site.
  • Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical
  • Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure
  • Understanding of site engagement and ability to customize site engagement strategy for assigned
  • Able to connect the study protocol, scientific principles and clinical trial requirements to the
  • May participate/lead in global/local task forces and initiatives.

🎯 Requirements

  • Appropriate tertiary qualification in health related disciplines (e.g., Medical, Scientific
  • Independent clinical research monitoring experience of investigational drug or device trials in any
  • Familiar with risk-based monitoring approach, onsite and offsite monitoring
  • Knowledge of appropriate therapeutic area indications
  • Knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and
  • Demonstrate advanced communication skills and superior cross-functional collaboration skills

🎁 Benefits

  • Excellent development opportunities
  • Reward and benefits package
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