Clinical Research Associate II - FSO

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

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.

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.