Senior Clinical Research Associate

Clinical Research Associate II / Senior Clinical Research Associate – UK – greater London/South-East

Upsilon Global are seeking a CRA II/SCRA based in commutable distance to London (3-days per week), on behalf of a unique full-service CRO. Whilst the role will predominantly involve remote monitoring visits, it will also provide the opportunity for international monitoring across The US and Canada, creating a fantastic opportunity for anyone looking to expand their monitoring and regulatory experience or simply travel the world a bit more!

The ideal candidate will have at least 2-years monitoring experience, preferably with (some form of) international experience monitoring (across North America/Canada/LATAM/Europe), as well as the ability to communicate in Spanish. They will take a hands‑on approach to monitoring, demonstrating excellent organisational skills, strong communication and the ability to work independently across multiple sites.

Company information:

Our CRO partner has a bespoke service offering to their pharma and biotech clients by boasting an internal global site network of over 3000 sites across 40 countries, allowing them to provide a fully integrated clinical trial management service. You will be provided with ample opportunity for international monitoring/travel, creating a fantastic environment to grow, develop and experience different clinical research environments, regulations and cultures.

Responsibilities

Monitoring and Site Management:

• Conduct site qualification, initiation, monitoring, and close-out visits in accordance with study plans.
• Perform both on-site and remote monitoring activities to ensure protocol compliance, participant safety, data quality, and regulatory adherence.
• Prepare for monitoring visits, document findings, issue follow-up letters, and complete monitoring reports within required timelines.
• Track site performance, recruitment progress, activation timelines, and key study deliverables; identify risks or blockers; and proactively implement corrective and preventive actions.
• Act as the primary point of contact for assigned study sites, providing ongoing support and guidance throughout the study lifecycle.
• Ensure timely resolution of site queries and escalte significant issues where appropriate.

Start-up and Regulatory

• Support study start-up activities, including site selection, feasibility, ethics and regulatory submissions, and site activation.
• Coordinate site contracts, confidentiality agreements, letters of intent, informed consent documentation, budget/payment-related documentation and other essential trial documentation through review, signature, approval, and activation.
• Facilitate site initiation activities, ensuring all required approvals and documentation are in place before recruitment begins.
• Liaise with ethics committees, regulatory authorities, sponsors, investigators, and vendors throughout study start-up.

Documentation and Compliance

Maintain complete, accurate, and inspection-ready Trial Master File (TMF) and Investigator Site Files (ISF).

• Ethics approvals and continuing review documentation
• Investigator CVs and training records
• Delegation and training logs
• Laboratory certifications and reference ranges
• Financial and payment documentation
• Ensure all documentation is filed, version-controlled, and maintained with a clear audit trail in accordance with company SOPs and regulatory requirements.

Experience and Background

• 1–2 years' experience as a Clinical Research Associate within clinical trials.
• International monitoring experience (on-site/remote) preferable
• Fluency or ability to communicate in Spanish preferable
• Good understanding of ICH-GCP, applicable regulations, and clinical research processes.
• Strong organisational and time management skills with the ability to manage multiple priorities site timelines, competing deliverables, and urgent follow-ups independently.

Education and Qualifications

• Bachelor's degree in Life Sciences or another relevant scientific discipline.
• Sound knowledge of ICH/GCP and regulatory requirements
• Experience using clinical trial management systems