11 oct
|
Crovelis
|
España
Senior Clinical Research Associate | Madrid Solicitar este puesto es simple. CROVELIS is looking for a Senior Clinical Research Associate (Senior CRA) to independently lead the management, start-up, monitoring, oversight and close-out of assigned clinical trial sites, including complex and high-priority sites . The successful candidate will play a key role in study execution, working closely with investigators, study coordinators, internal teams and other stakeholders to ensure data quality, patient safety, protocol compliance and the successful delivery of clinical trials within agreed timelines . We are looking for someone with strong clinical monitoring experience, a high level of autonomy, a risk-based mindset and a strong commitment to quality and continuous improvement. If you are motivated by taking ownership, working in an international environment and contributing directly to the successful delivery of clinical trials, we would love to hear from you . As a Senior CRA ,
you will be responsible for the management and oversight of assigned clinical trial sites throughout the different stages of the study. Independently manage assigned clinical trial sites throughout the study lifecycle. Conduct site initiation, routine monitoring and close-out visits in accordance with the monitoring plan, study timelines and regulatory requirements. Prepare accurate, clear and timely monitoring visit reports and follow-up letters. Review clinical and regulatory documentation to ensure consistency, completeness and quality. Support data review and query resolution in collaboration with sites and study teams. Work closely with Clinical Operations, Data Management, Medical, Regulatory and other cross-functional teams. Proactively elevate significant site risks, quality concerns and relevant operational issues. Contribute to study-level operational discussions and planning related to site management and trial execution. Ensure compliance with ICH-GCP, corporate SOPs, study prot
📌 Research Associate (España)
🏢 Crovelis
📍 España