Senior Clinical Research Associate – FSP

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan, applicable laws, GCP, and client standards
• Manage operational aspects of clinical trial activities at assigned investigator sites from site activation through database lock
• Serve as the primary point of contact for assigned investigator sites
• Partner with and/or escalate to the SCP to ensure quality of site delivery
• Attend investigator meetings when required, virtually or face-to-face
• Provide enrollment support and address site activation and recruitment issues
• Support recruitment initiatives at site level with the SCP and study team
• Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring, and site closure
• Monitor site-level adverse events and serious adverse events and collaborate with the Drug Safety Unit
• Submit required reports, documentation, updates, and tracking within required timeframes, including TMF documentation, site reports, follow-up letters, protocol deviations, recruitment, clinical supply management, study progress, and metrics
• Identify and resolve investigator site issues and develop corrective and preventative actions
• Resolve data queries and prepare and conduct investigator site close-out activities

• Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
• 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
• Global clinical trial experience
• Must be fluent in English
• Significant travel across whole Turkey
• Valid driver’s license and passport required
• Demonstrated knowledge of clinical research and development processes
• Demonstrated knowledge of global and local regulatory requirements
• Demonstrated understanding of key operational elements of clinical research, including monitoring, data acquisition and cleaning, and reporting
• Demonstrated knowledge in disease and technical areas pertaining to clinical studies
• Demonstrated ability to support sponsor regulatory interactions/inspections
• Demonstrated knowledge of protocol design and feasibility assessment processes
• Demonstrated understanding of region/country, culture, and medical practice and their effect on clinical trial delivery
• Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation
• Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent