Freelance Clinical Research Associate (CRA) – Czech Republic
Secteur : Industrie du médicament humain Famille de fonction : Développement clinique
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Description du poste et des missions
Clinact, a Contract Research Organization (CRO) specializing in clinical research, is looking for an experienced Freelance Clinical Research Associate (CRA) fluent in Czech to support monitoring activities at investigator sites in the Czech Republic.
The assignment will involve an initial monitoring visit before the end of 2026, followed by occasional monitoring visits throughout 2027, depending on study requirements.
This is an ad-hoc freelance opportunity, ideal for an independent CRA looking for occasional assignments.
Key Responsibilities
- Conduct on-site monitoring visits at investigator sites in the Czech Republic.
- Perform Source Data Verification (SDV) and Source Data Review (SDR), ensuring data accuracy and consistency with the EDC system.
- Ensure compliance with study protocols, ICH-GCP guidelines and applicable local regulatory requirements.
- Review and follow up on Investigator Site File (ISF) documentation.
- Identify, document and follow up on any issues or deviations identified during monitoring visits.
- Prepare monitoring visit reports and ensure appropriate follow-up of outstanding actions.
Profil souhaité
Profile
- Previous experience as a Clinical Research Associate (CRA), with proven experience in on-site monitoring.
- Fluency in Czech is mandatory.
- Good command of English, both written and spoken.
- Sound knowledge of ICH-GCP guidelines and clinical research regulations.
- Ability to work independently and manage monitoring activities autonomously.
- Based in the Czech Republic or willing and able to travel there for monitoring visits.
- Freelance status and availability for occasional assignments are required.
Assignment Details
- Contract: Freelance
- First assignment: One monitoring visit before the end of 2026
- Further assignments: Occasional visits throughout 2027
- Duration: Approximately 2 days per visit, including on-site activities and travel arrangements.