Clinical Research

• Perform site qualification, site initiation, interim monitoring, site management and close-out visits on-site or remotely
• Ensure regulatory, ICH-GCP/GPP and protocol compliance
• Evaluate site and site staff performance and develop or escalate action plans
• Verify informed consent, subject/patient safety and clinical data integrity
• Assess site processes and conduct source document review and medical record review
• Verify clinical data in case report forms and drive query resolution to closure
• Support clinical study data review, capture and electronic data capture compliance
• Perform investigational product inventory, reconciliation, storage, dispensing and administration reviews
• Review Investigator Site Files and reconcile them with Trial Master Files
• Document monitoring activities through letters, trip reports, communication logs and project documents
• Support subject/patient recruitment, retention and awareness strategies
• Track observations, status and action items through resolution
• Manage site-level activities and communications against project scope, budgets, timelines and deliverables
• Liaise with study site personnel and train assigned site/project team members
• Attend investigator meetings, sponsor meetings, global project meetings and clinical training
• Support audit readiness, audit preparation and follow-up actions
• For Real World Late Phase: support sites throughout the study lifecycle, conduct chart abstraction and data collection, collaborate with sponsor affiliates and local staff, train junior staff, identify out-of-scope activities and suggest potential sites

Explore CRA II/Sr CRA - Oncology at Syneos Health. Review requirements and application details.