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 activities
• Perform site management, initiation, monitoring and close-out visits on-site and remotely
• Prepare visit reports
• Conduct source data verification
• Support audits and inspections at study sites
• Manage data queries in collaboration with data management and project management
• Provide EDC training for site staff
• Prepare 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
• Strong knowledge of local regulatory requirements in the Czech Republic
• Hands-on experience with submissions, interactions with local authorities and site contract management
• Fluent Czech and English, written and spoken
• Live in the Czech Republic
• Willingness to travel regularly to sites nationwide
• Independent contractor status (IČO)

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