Senior Clinical Research Associate
15 hours ago
Madrid
Travel: Availability to travel across Europe and internationally when required Want to know more? 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. Your key responsibilities will include: • 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., • Review source documentation, CRFs and site records to verify accuracy, completeness and protocol compliance., • Ensure essential study documentation is complete, up to date, accurate and inspection-ready., • Verify that informed consent is obtained and documented appropriately in accordance with the protocol, ICH-GCP and applicable regulations., • Identify, assess and manage site issues, protocol deviations and operational risks., • Drive the timely follow-up and resolution of issues and action items., • 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., • Act as the primary point of contact for assigned sites., • Maintain effective communication with investigators, study coordinators and site staff., • Advise sites on protocol requirements, study procedures, investigational product accountability and GCP requirements., • 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 ., • Drive site-level inspection readiness through proactive oversight of documentation, processes and outstanding actions., • 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., • Share best practices and lessons learned across the Clinical Operations team., • Contribute to overall study development through effective site-level leadership, risk management and cross-functional collaboration. 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., • Additional certifications or qualifications will be considered a plus., • 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., • Experience managing complex sites, operational issues and escalated situations., • 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., • Proven ability to identify, assess and manage complex site issues, protocol deviations and operational risks., • Knowledge of site-level quality standards and inspection readiness ., • Experience applying a risk-based oversight approach, with strong prioritisation and escalation skills., • Native-level French is required., • Fluent English , both written and spoken., • Additional European languages will be considered a plus., • Excellent communication and interpersonal skills., • Strong organisational, prioritisation and problem-solving abilities., • High level of autonomy and ability to make sound decisions in a dynamic environment., • Strong ability to collaborate with multidisciplinary and international teams., • Ability to coach and support junior or less experienced CRA profiles., • Good knowledge of Microsoft Office and clinical trial systems., • Strong reporting skills and attention to detail, with the ability to maintain accurate and well-organised study records., • Willingness and availability to travel across Europe and internationally when required . 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. At CROVELIS , we are committed to fostering a diverse, inclusive and equal-opportunity workplace. 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. We are committed to ensuring fair and non-discriminatory recruitment processes. #J-18808-Ljbffr
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