Clinical Research Associate - Monitoring Experience Required
hace 8 días
Lugo
At Artivion, we manufacture high-quality products and solutions for the treatment of aortic diseases. Asegúrese de inscribirse rápido, ya que se espera un gran volumen de solicitudes. We are hiring a Clinical Research Associate III - Home-Base in Spain (Spanish speaking candidates in France are also welcome). • Minimum of 4 years of advanced experience in clinical research monitoring, • In-depth knowledge of regulations and guidelines related to clinical trials involving human subjects (e.g., ISO 14155, GCP, MDR, EU, FDA), • Ability to independently manage 10-15 study sites from start-up through close-out, • Excellent communication skills for site interaction, training, and issue resolution, • Strong collaboration and mentorship abilities, with a passion for supporting and guiding junior team members, • Hands-on experience with monitoring systems, source data verification, and compliance tracking, • Strong organizational skills with the ability to manage multiple priorities in a dynamic environment, • Willingness to travel regularly for site visits and investigator meetings across France and Spain, • Based in Spain (candidates from France may be considered in case a candidate lives nearby the Spain/France border and eager to do cross-border monitoring), • Fluent communication in English and Spanish (Catalan is preferred, French optional), • Independently manage all phases of clinical trial site activities, including site identification, initiation, monitoring, and close-out, • Conduct monitoring visits in accordance with study protocols, GCP, and applicable regulatory requirements, • Act as the primary contact for investigational sites, ensuring compliance and providing ongoing support, • Build and maintain strong relationships with investigators, study coordinators, and site personnel, • Identify study risks, recommend solutions, and ensure timely resolution of site-related issues, • Perform source data verification and data review to ensure patient safety, protocol compliance, and data integrity, • Conduct site training, initiation visits, and support audit and inspection readiness, • Collaborate closely with Clinical Operations, Data Management, Medical Affairs, and other cross-functional teams, • Support investigator meetings, coordinator meetings, and deliver presentations or training sessions when required, • Mentor junior CRAs and contribute to process improvements and best practices, • Participate in CAPA activities, quality initiatives, audits, and continuous improvement efforts, • A mission-driven company focused on saving lives, • International and collaborative MedTech environment, • Hybrid working model with flexibility, • Opportunities for growth and professional development, • Innovative products and meaningful clinical impact We look forward to receiving your application documents in English through our online application system. #J-18808-Ljbffr