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AI Summary
Conduct site monitoring visits including initiation, routine, and close-out while ensuring patient safety and protocol compliance. Manage site documentation, source data verification, and investigational product accountability to maintain high data quality.
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.
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