Clinical Research Associate – Home-based
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Job Description
Freelance CRA overseeing approximately 10 Czech study sites for Alcedis, a German clinical research organization. Managing monitoring, regulatory submissions, contracts, and international study coordination.
Responsibilities:
- 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
Requirements:
- 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
Benefits:
- 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
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