CRA II

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

Essential Requirements

• 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