Single Sponsor Senior Clinical Research Associate (UK monitoring experience needed)

Role overview

Clinical monitoring and site management

• Perform site qualification, initiation, interim monitoring, site management and close-out visits on site or remotely, ensuring regulatory, ICH-GCP or GPP and protocol compliance.
• Evaluate site and staff performance, recommend site-specific actions, escalate serious issues and develop action plans.
• Verify informed-consent processes and documentation, protect participant confidentiality, and assess factors affecting participant safety and clinical-data integrity.
• Review source documents and medical records against case report forms for data accuracy and completeness; resolve queries and guide site staff.
• Support clinical data review and capture using available hardware and software, and verify electronic data-capture compliance.
• As needed, reconcile investigational products and review storage, security, dispensing, administration and related study requirements.
• Review Investigator Site Files, reconcile them with Trial Master Files and ensure essential-document archiving requirements are understood.
• Document monitoring activities, support participant recruitment and retention, and track observations and action items to resolution.
• Manage site activities and communication to support project objectives, deliverables and timelines.

Knowledge and experience

• UK monitoring experience is identified as needed in the job title.
• Maintain working knowledge of ICH/GCP guidelines or other applicable guidance, relevant regulations and company SOPs/processes.
• Understand project scope, budgets and timelines for clinical-team activities.

About Syneos Health