Clinical Research Associate (f/m/d) EMEA
External
Zoll · Cologne, GermanyPrepare for this interview
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CMS The Cardiac Management Solutions division of ZOLL Medical Corporation develops products to protect and manage cardiac patients, including the LifeVest® wearable cardioverter defibrillator (WCD), the ZOLL cardiac monitor, and associated technologies. The LifeVest is a wearable defibrillator worn by patients at risk for sudden cardiac arrest (SCA), providing protection during their changing condition and while permanent SCA risk has not been established. The LifeVest allows a patient's physician time to assess their long-term arrhythmic risk and make appropriate plans. Our mission: "Saving more lives!" Our EMEA team is looking for a dedicated and motivated Clinical Research Associate (CRA) to support us in the execution and monitoring of clinical trials. In this role, you will play a key part in ensuring the quality and integrity of our clinical research projects from planning through to implementation. Clinical Research Associate (f/m/d) remote (EMEA) (full time / unlimited) Areas of Responsibility: Monitoring and site management activities for clinical research projects Acting as liaison between the company and clinical sites to resolve any site-related issues quickly and effectively Preparation of study-related documents including but not limited to informed consent forms, Notes to File, etc. Monitor ongoing compliance with study protocols and site adherence to global regulatory guidelines, including safety reporting Responsible for the distribution, collection and tracking of regulatory documentation and support regulatory submissions Support clinical operations management in project management Partner with cross-functional teams (EMEA and US) such as data management and medical affairs with query management, data reviews and resolution Coordinate or manage multiple projects across multiple centers and countries Travel to study sites based on project needs Perform other duties as assigned by management Ability to travel up to 65%, based on project needs, including national and international conferences and responsibilities Participate in research meetings including presentations at those meetings Experience and Personal Qualities: MS/PhD in a clinical, scientific, or related field; and ideally 3+ years of experience in the medical industry Cardiology experience preferred Strong working knowledge of medical/scientific terminology and working knowledge of Ministry of Health regulations and GCP guidelines is required Knowledge of the legal and regulatory landscape concerning clinical research Professional proficiency in English (written and spoken) and one other major European language (preferably French, Italian or Spanish) Demonstrated proficiency in implementing, monitoring, and management of clinical trials (start-up to close-out) Presentation skills Proficient in Microsoft Office, including Word, Excel, and Project
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