Senior Clinical Research Associate

• 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
• Serve as the primary point of contact for assigned investigator sites during study conduct
• Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
• Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel
• Provide protocol training to, and address protocol related questions from the investigator site staff
• Attend investigator meeting when required (virtual or F2F)
• Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities
• Monitor site level adverse events (AEs) and serious adverse events (SAEs)
• Submit all required reports, documentation, updates and tracking within required timeframes
• Identify and resolve investigator site issues within required timeframes
• Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities
• Ensures adequate oversight of the investigational product at the investigator site
• Support database release as needed
• May undertake the responsibilities of an unblinded monitor where appropriate
• Maintain thorough understanding of the product, protocol and therapy area
• Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership
• Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
• Drive Quality Event (QE) remediation, when applicable
• Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable

• Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
• Monitoring Experience: 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
• Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases

• Patient-focused in everything we do
• Supportive and inclusive environment
• Career growth and development
• Flexible work arrangements
• Diverse therapeutic areas and project exposure
• Advanced Technology