Company: Syneos Health
Location: London
Job Description:
Overview
As a CRA II in the UK, you monitor and manage clinical site performance to ensure regulatory and protocol compliance. You will work within the Clinical Solutions group, collaborating with cross-functional teams to support data quality and patient safety. You drive site qualification, initiation, interim monitoring, and close-out activities, remotely or on-site. This role offers exposure to real-world late-phase studies and opportunities to mentor junior staff while shaping study execution and audit readiness. You will contribute to delivering high-quality trials that advance patient outcomes.
Responsibilities
- Conduct site qualification, initiation, monitoring, and close-out visits in compliance with ICH-GCP and applicable guidelines
- Assess site performance and escalate issues; develop action plans with the project team
- Maintain knowledge of regulatory requirements and SOPs; verify informed consent and patient confidentiality
- Perform source data verification, data entry checks, and query resolution; support IP handling and randomization integrity
- Review ISF vs TMF, ensure archiving, and support audit readiness
- Support patient recruitment, retention, and site communication; track observations and action items in tracking systems
- Manage assigned site activities within scope, budget, and timelines; adapt to changing priorities
- Prepare for Investigator Meetings and participate in global project meetings
Key requirements
- Bachelor’s degree in a related field or RN
- Knowledge of Good Clinical Practice/ICH guidelines and regulatory requirements
- Strong computer skills; ability to adopt new technologies
- Excellent communication, presentation, and interpersonal skills
- Ability to travel up to 30–40% regularly
- UK monitoring experience required
- Excellent communication
- Interpersonal skills
- Adaptability
- ICH-GCP and GPP knowledge
- Electronic data capture and data review
- ISF/TMF reconciliation
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Posted: October 1st, 2026