03 oct
|
Crovelis
|
Madrid
Senior Clinical Research Associate | Madrid 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 protocols and applicable local and international regulations. Protect the rights, safety and well-being of clinical trial participants throughout the study.
Provide guidance and support to junior or less experienced CRAs and contribute to onboarding, training and knowledge-sharing initiatives. We are looking for a strong clinical research professional who brings solid monitoring experience, operational leadership and a quality-focused mindset. Bachelor's or Master's degree in Life Sciences, Pharmacy, Chemistry, Medicine, Nursing, Biotechnology or another relevant scientific discipline.
At least 5 years of experience in clinical research, including clinical trial monitoring and independent site management.
Experience within the pharmaceutical, biotechnology, CRO/service provider or healthcare sector. Strong knowledge of ICH-GCP, applicable clinical research regulations and monitoring practices. Solid understanding of clinical trial processes, site management, monitoring activities and essential study documentation. Knowledge of site-level quality standards and inspection readiness. Native-level French is required.
Fluent
English, both written and spoken. Ability to coach and support junior or less experienced CRA profiles. Good knowledge of Microsoft Office and clinical trial systems. You will have the opportunity to work in an international environment, collaborate with multidisciplinary teams and contribute to clinical trials where your expertise can have a direct impact on study quality and execution.
We are looking for people who want to continue growing, take on meaningful challenges and contribute to the advancement of clinical research. All applications will be considered regardless of gender, gender identity or expression, age, ethnicity, nationality, religion, sexual orientation, disability or any other personal, physical or social condition.
📌 Research Associate (Madrid)
🏢 Crovelis
📍 Madrid