Compliance Clinical Trials Assistant

Key Responsibilities

• Document Oversight: Managing and organising essential trial documents (e.g., Trial Master File / TMF).
• Regulatory Compliance Support: Ensuring studies follow guidelines like GCP (Good Clinical Practice), SOPs, and regulatory requirements.
• Audit and Inspection Readiness: Supporting preparation for audits or inspections from regulators (e.g., MHRA, FDA).
• Tracking and Reporting: Monitoring compliance metrics, deviations, and quality issues.
• Process Improvement: Identifying gaps and helping improve compliance processes.

What We're Looking For

• Previous compliance experience within clinical trials required.
• Fluency in English (written and spoken).
• Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH).
• Degree in life sciences or equivalent industry experience.
• Valid right to work for country of residence (the role is not eligible for visa sponsorship).