Clinical Research

• Perform site qualification, site initiation, interim monitoring, site management and close-out visits on-site or remotely
• Evaluate site and site staff performance, communicate or escalate serious issues, and develop action plans
• Verify informed consent processes and protect subject/patient confidentiality
• Assess subject/patient safety, clinical data integrity, protocol deviations and pharmacovigilance issues
• Conduct source document review and verify clinical data entered in case report forms
• Resolve queries remotely and on site, guide site staff, and ensure closure within agreed timelines
• Use hardware and software for clinical study data review and capture; verify electronic data capture compliance
• Perform investigational product inventory, reconciliation and storage/security reviews as required
• Review Investigator Site Files and reconcile them with Trial Master Files
• Document activities through confirmation letters, follow-up letters, trip reports, communication logs and other project documents
• Support subject/patient recruitment, retention and awareness strategies
• Track observations, site status and action items to resolution
• Manage assigned site-level activities and communications to meet project scope, deliverables, budgets and timelines
• Act as primary liaison with study site personnel or collaborate with Central Monitoring Associates
• Ensure assigned sites and project-specific site team members are trained and compliant
• Prepare for and attend Investigator Meetings, sponsor meetings, global monitoring/project meetings and clinical training
• Provide site and project-level guidance for audit readiness and support audit preparation and follow-up
• For Real World Late Phase, support sites throughout the 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 out-of-scope activities, and suggest potential sites based on local knowledge

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