CRA - Bulgaria and UK

Key Responsibilities

• Manage and monitor clinical trial sites in compliance with Fortrea SOPs, ICH‑GCP, protocol requirements, and applicable regulations, including pre‑study, initiation, routine monitoring, and close‑out visits.
• Ensure subject safety and data integrity through informed consent review, source data verification, issue identification, query management, and timely resolution using Fortrea or sponsor systems.
• Maintain site audit readiness by overseeing regulatory documentation, eTMF completeness, investigational product accountability, and protocol adherence throughout the study lifecycle.
• Collaborate closely with cross‑functional study teams to align monitoring activities with study timelines, deliverables, and quality expectations; act as Lead CRA when assigned.
• Prepare accurate monitoring documentation, visit reports, and contribute to study planning, site training, and investigator meetings as required.

Requirements

• University degree or certification in a life sciences or allied health discipline (or equivalent relevant experience).
• Minimum 2 years of independent clinical monitoring experience in accordance with ICH‑GCP and regulatory requirements.
• Strong knowledge of clinical trial processes, monitoring practices, SAE reporting, and data review standards.
• Ability to work independently with minimal supervision, managing multiple priorities in a matrix environment.
• Fluency in English and Bulgarian (written and spoken); willingness to travel extensively (approximately 60%).
• Readiness to travel to the UK regularly.