Clinical Research Associate – Home-based

This is a fully remote position, open to applicants in Czechia.

📋 Description

• Assist the Clinical Operations team in an international non-interventional study.

• Independently oversee around 10 study sites across the Czech Republic.

• Serve as the local liaison for the international project team.

• Execute site qualification and feasibility assessments, site management, and conduct initiation, monitoring, and close-out visits both on-site and remotely.

• Draft visit reports.

• Conduct source data verification and support audits and inspections at study sites.

• Manage queries in collaboration with data management and project management teams.

• Deliver EDC training to site personnel.

• Coordinate with the international project team.

• Manage study submissions and notifications to Ethics Committees and, when necessary, local authorities.

• Engage with local regulatory authorities.

• Oversee site contracts within the Czech Republic.

• Travel frequently to study sites throughout the Czech Republic.

⛳️ Requirements

• A minimum of 5 years of experience as a CRA in GCP-compliant clinical research within the industry (e.g., CRO, pharma, or biotech).

• Experience in managing multinational non-interventional studies.

• Comfort working with English-language study documentation, including protocols, monitoring plans, manuals, and eCRF guidelines.

• Familiarity with local regulatory requirements in the Czech Republic.

• Practical experience with submissions, interactions with local authorities, and site contract management.

• An independent, proactive, and conscientious work ethic.

• Strong planning and organizational skills, with the ability to prioritize and navigate complex situations.

• Effective communication skills, including on critical topics.

• Proficiency in both Czech and English, written and spoken.

• Must reside in the Czech Republic.

• Willingness to travel frequently to sites nationwide.

🏝️ Benefits

• Flexible, home-based working arrangements.

• Fixed-term freelance engagement as an independent contractor (IČO), approximately 60 hours per month for around 10 months.

• Diverse role offering a high level of responsibility and autonomy.

• Collaboration with an experienced, international project team.