Clinical Research

• Perform site qualification, site initiation, interim monitoring, site management activities and close-out visits
• Evaluate site and site staff performance and provide recommendations regarding site-specific actions
• Escalate serious issues to the project team and develop action plans
• Verify informed consent processes, subject/patient confidentiality, safety and clinical data integrity
• Conduct source document review and verify clinical data accuracy and completeness
• Resolve queries remotely and on site within agreed timelines
• Verify compliance with electronic data capture requirements
• Manage investigational product inventory, reconciliation, storage, dispensing and administration checks
• Review Investigator Site Files and reconcile them with Trial Master Files
• Document activities through confirmation letters, follow-up letters, trip reports and communication logs
• Support subject/patient recruitment, retention and awareness strategies
• Track observations, ongoing status and action items to resolution
• Manage site-level activities, communications, project objectives, deliverables and timelines
• Act as liaison with study site personnel and ensure site team training and compliance
• Attend investigator, sponsor and global clinical monitoring meetings and training sessions
• Support audit readiness and audit follow-up actions
• Support sites throughout the real world late phase study lifecycle
• Perform chart abstraction and data collection
• Collaborate with sponsor affiliates, medical science liaisons and local country staff
• Train junior staff when requested
• Identify and communicate out-of-scope activities
• Suggest potential sites based on local treatment patterns, patient advocacy and HCP associations

Explore CRA II – Sponsor-dedicated at Syneos Health. Review requirements and application details.