other
Posted 1 weeks agoCRA II - Romania
at Fortrea
Bucharest, RomaniaOn-site
Responsibilities
- requirements Ensure patient safety and protocol compliance, including informed consent and eligibility verification Perform source data verification, resolve queries, and maintain high data quality and integrity Maintain site documentation (ISF/eTMF) and ensure audit readiness at all times Manage investigational product accountability and site supplies in line with protocol
- requirements Collaborate with study teams to deliver milestones, prepare reports, and support timelines
Requirements
- Here in Fortrea we are looking for an experienced CRA to join our miltisponsor team.
- Responsibilities: Conduct site monitoring visits (initiation, routine, close-out) in line with SOPs, ICH-GCP, and study
- Requirements: Degree in Life Sciences, Nursing, or related field (or equivalent experience) Minimum 2 years of independent clinical monitoring
- experience Strong knowledge of ICH-GCP, clinical trial processes, and regulatory
- requirements Ability to work independently, with good organisation and problem-solving skills
- Experience with eClinical systems (e.g.
- CTMS, eCRF) and solid MS Office skills Fluency in English and Romanian languages; willingness to travel (~60%) Learn more about our EEO & Accommodations request here .