CRA II - Romania

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%)