Senior Clinical Research Associate, All Levels
Job Description:
• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality
• Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
• Serve as the primary point of contact for assigned investigator sites during study conduct
• Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators
• Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit
Requirements:
• Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
• Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
• Must be fluent in English and in the native language(s) of the country they will work in
• Ability to travel 60-80%
• Valid driver’s license and passport required
Benefits:
• Health insurance
• Paid time off
• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality
• Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
• Serve as the primary point of contact for assigned investigator sites during study conduct
• Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators
• Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit
Requirements:
• Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
• Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
• Must be fluent in English and in the native language(s) of the country they will work in
• Ability to travel 60-80%
• Valid driver’s license and passport required
Benefits:
• Health insurance
• Paid time off