CRA II

Location

United Kingdom (Field-based)

• Face-to-face meetings in London where applicable
• Regional monitoring with travel required

• Ideally 2 years’ CRA experience (candidates with ~1.5 years’ experience will be considered)

Our client is seeking a motivated and experienced Clinical Research Associate (CRA) to support the delivery of high-quality clinical trials across the UK. The CRA will be responsible for site monitoring, ensuring compliance with ICH‑GCP, protocol, SOPs, and applicable regulatory requirements, while maintaining strong relationships with investigative sites.

• Perform on-site, remote, and hybrid monitoring visits, including:
• Site Qualification Visits (SQV)
• Site Initiation Visits (SIV)
• Routine Monitoring Visits (MV)
• Close-Out Visits (COV)
• Conduct 1–2 monitoring visits per week (approximately 6–8 visits per month)
• Ensure trials are conducted in compliance with ICH‑GCP, protocol, SOPs, and regulatory requirements
• Verify informed consent processes and source data verification (SDV)
• Review and ensure accuracy, completeness, and timeliness of clinical trial data
• Identify, document, and follow up on issues, deviations, and corrective/preventive actions (CAPAs)
• Ensure investigational product (IP) handling, storage, and accountability are compliant
• Support sites with protocol adherence, data entry, and query resolution
• Maintain up-to-date and accurate Trial Master File (TMF) and site files (CTMS)
• Prepare and submit timely monitoring visit reports and follow-up letters
• Act as the primary point of contact for assigned study sites
• Build and maintain strong, collaborative relationships with investigators and site staff
• Escalate risks and issues to the CRA Manager or study team as appropriate
• Participate in internal meetings, training, and ongoing process improvement initiatives

• Bachelor of Science (BSc) degree (mandatory)
• Valid UK driver’s licence (mandatory)
• Minimum 1.5–2 years of experience as a Clinical Research Associate
• Strong knowledge of ICH‑GCP and clinical trial processes
• Experience with site monitoring across multiple visits
• Excellent organisational, communication, and interpersonal skills
• Ability to work independently in a field-based role
• Willingness to travel extensively across the UK