healthcare
Posted 2 days agoClinical Research Associate II - FSO
at Fortrea
Budapest, HungaryOn-site
Responsibilities
- Conduct all phases of site monitoring visits (pre-study, initiation, routine, and close-out), ensuring subject safety, protocol adherence, and data integrity.
- Perform source data verification, query resolution, and eCRF review to ensure high-quality, audit-ready clinical data.
- Maintain and update essential documents in eTMF and sponsor systems, ensuring regulatory and documentation completeness throughout the study lifecycle.
- Monitor investigational product (IP) accountability, storage, and compliance with protocol and regulatory standards.
- Collaborate with cross-functional teams to align site performance with study timelines, metrics, and quality expectations. Required
Requirements
- Responsibilities: Manage clinical trial sites in alignment with Fortrea SOPs, ICH-GCP, project plans, and sponsor requirements, including oversight of training documentation and regulatory compliance.
- Qualifications : University or college degree in life sciences, nursing, pharmacy, or a related allied health profession; equivalent relevant
- experience may be considered in lieu of formal education. Solid understanding of ICH-GCP guidelines and local regulatory
- Working knowledge of clinical trial processes and monitoring procedures.
- Proficient in using clinical systems and tools; able to work independently and travel as required.
Additional details
- In this CRA position, you’ll help transform complex clinical protocols into real-world results, working alongside a team that values precision, integrity, and progress.
- This role will offer you the opportunity to directly influence the success of global clinical trials and the delivery of innovative therapies to patients worldwide. Key
- Strong attention to detail and ability to follow complex protocols and documentation standards.
- Why Join Us? Contribute to advancing innovative therapies and improving patient outcomes through meaningful clinical research on a global scale.
- Thrive in a collaborative environment that values continuous learning, mentorship, and professional development.