Clinical Study Associate, Clinical Operations

About This Role

This office-based, hybrid role in Uxbridge, UK, supports multiple clinical trials, ensuring compliance with all relevant guidelines and regulations. The position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Responsibilities

• Support multiple clinical trials while ensuring compliance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and regulations
• Participate in study team meetings and coordinate agendas, minutes, and logistics
• Request, collect, review, and track site regulatory documents and start-up activities
• Maintain, reconcile, and quality check essential documents and the electronic Trial Master File (eTMF)
• Support study reporting tools, monitoring visit schedules, investigator materials, and study binders
• Manage Clinical Disclosure Agreements, consulting agreements, and internal review committee submissions
• Maintain accurate data in the Clinical Trial Management System (CTMS) and monitor trial disclosure requirements
• Track study closeout activities, reports, financial requisitions, and Clinical Research Associate (CRA) closeout visits

Requirements

• Bachelor’s degree preferred; Associate degree may be accepted
• 0-1 year of relevant experience
• Knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and applicable regulations
• Experience reviewing and maintaining study documentation and electronic Trial Master Files (eTMF)
• Familiarity with Clinical Trial Management Systems (CTMS) and clinical reporting tools
• Ability to coordinate study activities, regulatory documentation, and committee submissions
• Strong organizational skills with attention to detail and document quality
• Ability to collaborate across clinical study teams and internal departments

Benefits

• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits
• 401(k) company match
• Health and wellness programs
• Fitness centers
• Insurance benefits (e.g. medical, dental, vision, life and disability)
• Paid time off
• Family support benefits

Important Details

• Work format: Office based, Hybrid Uxbridge, UK

About the Company

At Regeneron, science and innovation are used to develop life-changing medicines for people with serious diseases. Regeneron is committed to building a workplace with an inclusive culture.