Upsilon Global
Clinical Research Associate
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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 organizational 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 escalate significant issues where appropriate.
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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).
- Ensure essential documents remain current, including:
- Ethics approvals and continuing review documentation
- Investigator CVs and training records
- Delegation and training logs
- Laboratory certifications and reference ranges
- Site correspondence
- 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.
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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.
- Experience conducting independent site monitoring visits.
- Strong organizational 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
For further information on this opportunity and to learn of similar positions, please contact Upsilon Global on +4402038759966 or email applications@upsilonglobal.com
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