- Location
- Bucharest, Romania
- Type
- Full-time
- Experience
- 2+ years
- Source
- Workday
Description
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
- 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:
- 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.
Skills
GCPCompliance
