Single Sponsor CRA I / II (Must have UK monitoring exp)

Syneos Health is seeking a Single Sponsor CRA I / II with UK monitoring experience.

As a CRA, you will perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.

Responsibilities:

• Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits
• Evaluate overall performance of site and site staff, providing recommendations for site-specific actions
• Verify process of obtaining informed consent, protect confidentiality of subjects/patients
• Assess factors affecting subject/patient safety and clinical data integrity
• Conduct Source Document Review, verify clinical data accuracy and completeness
• Apply query resolution techniques, provide guidance to site staff
• Manage investigational product inventory, reconciliation, and storage/security
• Review Investigator Site File, reconcile contents with Trial Master File
• Document activities, support subject/patient recruitment and retention
• Understand project scope, budgets, and timelines; manage site-level activities
• May act as primary liaison with study site personnel
• Prepare for and attend Investigator Meetings and sponsor face-to-face meetings
• Provide guidance on audit readiness standards

Qualifications:

• Bachelor's degree or RN in a related field or equivalent experience
• Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
• Excellent communication, presentation, and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis