Clinical Research Associate – Home-based

• Support the Clinical Operations team in an international non-interventional study
• Independently manage approximately 10 study sites throughout the Czech Republic
• Act as the local point of contact for the international project team
• Conduct site qualification and feasibility, site management, and initiation, monitoring and close-out visits on-site and remotely
• Prepare visit reports
• Perform source data verification and support audits and inspections at study sites
• Manage queries in collaboration with data management and project management
• Provide EDC training for site staff
• Coordinate with the international project team
• Handle study submissions and notifications to Ethics Committees and, where required, local authorities
• Interact with local regulatory authorities
• Manage site contracts in the Czech Republic
• Travel regularly to study sites across the Czech Republic

• 5 or more years of experience as a CRA in GCP-compliant clinical research in the industry (e.g. CRO, pharma or biotech)
• Experience working on multinational non-interventional studies
• Confidence working with English-language study documentation, including protocols, monitoring plans, manuals and eCRF guidelines
• Knowledge of local regulatory requirements in the Czech Republic
• Hands-on experience with submissions, interactions with local authorities and site contract management
• Independent, proactive and conscientious working style
• Reliable planning and organization skills, ability to set priorities and manage complex situations
• Confident communication, including on critical topics
• Fluent in Czech and English, written and spoken
• Live in the Czech Republic
• Willingness to travel regularly to sites nationwide

• Flexible, home-based working
• Fixed-term freelance engagement as an independent contractor (IČO), approximately 60 hours per month for around 10 months
• Varied role with a high degree of responsibility and independence
• Collaboration with an experienced, international project team