Clinical Research Associate Iii
hace 1 día
Vitoria-Gasteiz
It's a good feeling to know you're doing your best with purpose every day. At Artivion, we manufacture high-quality products and solutions for the treatment of aortic diseases. Together with surgeons worldwide, we save lives. In doing so, we rely on the strengths of each and every employee. Your strength counts, too: As an important link in the chain, you make a contribution to saving lives together with us. Bring your strengths and let us grow together. La siguiente información ofrece un resumen de las habilidades, cualidades y cualificaciones necesarias para este puesto. We are hiring a Clinical Research Associate III – Home-Based in Spain (Spanish speaking candidates in France are also welcome) Your Strength • 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) Your Contribution • 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 Our Strength • 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 Contact Apply now and join the Artivion team. xkdbapo We look forward to receiving your application documents in English through our online application system. Brian Russo T: JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc. Lotzenäcker 23, 72379 Hechingen
