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.

• Take charge of managing approximately 10 study sites across the Czech Republic independently.

• Serve as the primary local contact for the international project team.

• Execute site qualification and feasibility assessments.

• Conduct site management, initiation, monitoring, and close-out visits, both on-site and remotely.

• Draft visit reports.

• Carry out source data verification.

• Provide support during audits and inspections at study sites.

• Collaborate with data management and project management to manage data queries.

• Deliver EDC training for site personnel.

• Prepare study submissions and notifications to Ethics Committees and local authorities, as necessary.

• 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).

• Proven experience in multinational non-interventional studies.

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

• Strong understanding of local regulatory requirements in the Czech Republic.

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

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

• Reside in the Czech Republic.

• Willingness to travel regularly to sites nationwide.

• Hold independent contractor status (IČO).

🏝️ Benefits

• A fixed-term freelance position (independent contractor, IČO) of approximately 60 hours per month for about 10 months.

• A diverse role that offers a high level of responsibility and autonomy.

• Opportunity to collaborate with an experienced international project team.

• Flexible, home-based working environment.