About The Position
Alcedis is seeking an experienced clinical research professional based in the Czech Republic to work as a freelance Clinical Research Associate on an international non-interventional study. The independent contractor (IČO) engagement is fixed-term and project-based, planned for approximately 10 months, with an average workload of around 60 hours per month. The project is expected to run until Q3 2027. The ideal start date is 1 December 2026, with an earlier start in November possible. The CRA will independently manage approximately 10 study sites across the Czech Republic and serve as the local point of contact, collaborating with the international project team and project management in Germany. The role covers site oversight and quality standards, study submissions and notifications, interactions with local authorities where required, and site contract management in the Czech Republic. Work includes regular nationwide site travel as well as flexible, home-based working.
Requirements
- At least 5 years of experience as a CRA in GCP-compliant clinical research in industry, such as a CRO, pharmaceutical company, or biotech company.
- Experience working on multinational non-interventional studies and collaborating with international project teams.
- Confidence working with English-language study documentation, including protocols, monitoring plans, manuals, and eCRF guidelines.
- Strong knowledge of Czech local regulatory requirements and hands-on experience with submissions, local authority interactions, and site contract management.
- Independent, proactive, conscientious working style, with reliable planning and organization, clear prioritization, and pragmatic problem-solving in complex situations.
- Confident, committed communication, including on critical topics, and ability to represent requirements clearly while building trusting relationships with investigators and site staff.
- Fluency in written and spoken Czech and English.
- Residence in the Czech Republic and willingness to travel regularly to sites nationwide.
Responsibilities
- Manage approximately 10 study sites across the Czech Republic and act as the local point of contact.
- Conduct site qualification and feasibility activities, site management, and on-site and remote initiation, monitoring, and close-out visits; 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 to site staff and coordinate with the international project team.
- Prepare study submissions and notifications, interact with local regulatory authorities, and manage site contracts in the Czech Republic.
- Travel regularly to study sites across the Czech Republic.
Benefits
- Flexible, home-based working
- Collaboration with an experienced international project team
- A varied role with a high degree of responsibility and independence
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What This Job Offers
Career Level
Senior
Education Level
No Education Listed
