Clinical Research

• Perform feasibility studies for potential sites
• Conduct pre-study, study initiation and interim monitoring visits in adherence to protocol requirements
• Function as Lead CRA for global studies and coordinate CRAs
• Develop Clinical Monitoring Plans as requested
• Review site visit trip reports and provide feedback and edits
• Mentor and guide less experienced CRAs and site staff
• Design study-specific tools and templates
• Participate in study team, investigator and bid defense meetings
• Create and conduct training for study team members or colleagues
• Work with Project Management to evaluate deliverables and study milestones
• Compile regulatory and ethical submission documentation
• Coordinate study material shipment and receipt by sites
• Document site visit findings through written reports
• Provide input into protocols and CRFs
• Assess, monitor and train site staff on protocol adherence
• Review subject safety information and informed consent
• Conduct source document verification for compliance, patient safety and data veracity
• Review paper or electronic CRFs and assist with data query resolution
• Assist with Investigator Site File maintenance
• Maintain regular communication with sites
• Update site-related documentation for filing in the Trial Master File
• Ensure site compliance with investigational product receipt, accountability and return or destruction
• Conduct accompanied site visits for CRA assessment or training
• Complete final site close-out visit and report
• Perform other assigned duties

Clinical Research jobs in South Korea

Senior Clinical Research Associate