Clinical Research Associate is responsible for managing and monitoring clinical trials to ensure they are conducted in compliance with study protocols, ICH-GCP, and applicable regulations. This includes site selection, initiation, monitoring, and close-out activities, while ensuring data quality and patient safety. The role reports to the Clinical Project Manager.
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Key Responsibilities
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- Identify, assess, and initiate investigational sites
- Conduct feasibility, pre-study, initiation, monitoring, and close-out visits
- Ensure compliance with protocols, SOPs, ICH-GCP, and regulatory requirements
- Perform source data verification and ensure data accuracy and completeness
- Monitor patient recruitment and support sites in meeting targets
- Ensure proper reporting of adverse events and protocol deviations
- Manage investigational product handling, storage, and accountability
- Maintain study documentation (TMF/eTMF, Investigator Files)
- Write monitoring reports and follow-up communications
- Collaborate with project teams, sponsors, and site staff
- Support audits/inspections and mentor junior CRAs
Clinical Research Associate is responsible for managing and monitoring clinical trials to ensure they are conducted in compliance with study protocols, ICH-GCP, and applicable regulations. This includes site selection, initiation, monitoring, and close-out activities, while ensuring data quality and patient safety. The role reports to the Clinical Project Manager.
Key Responsibilities
-
- Identify, assess, and initiate investigational sites
- Conduct feasibility, pre-study, initiation, monitoring, and close-out visits
- Ensure compliance with protocols, SOPs, ICH-GCP, and regulatory requirements
- Perform source data verification and ensure data accuracy and completeness
- Monitor patient recruitment and support sites in meeting targets
- Ensu
📌 Clinical Research Associate (Madrid)
🏢 Opis
📍 Madrid