CRA Bulgaria and UK
Share
Job Location:
Monthly Salary:
Posted on:
17 hours ago
Vacancies:
1 Vacancy
Job Summary
Here at Fortrea we are currently recruiting for a CRA II in Bulgaria to cover sites in Bulgaria and UK.
Key Responsibilities
- Manage and monitor clinical trial sites in compliance with Fortrea SOPs ICHGCP protocol requirements and applicable regulations including prestudy initiation routine monitoring and closeout 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 crossfunctional 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 ICHGCP 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.
Learn more about our EEO & Accommodations request here.
