Clinical Research Associate / Senior CRA

Job description

Overview Innovation starts from the heart. Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. The Clinical Affairs team is looking for an experienced Clinical Research Associate or Senior CRA (depending on experience), to join our team in Germany. This role will require travel both regional and national for monitoring visits. Preferred locations for this role are Munich, Frankfurt, Hamburg, Stuttgart, Cologne and surrounding areas. This role will be responsible for site monitoring activities to ensure the overall integrity of study implementation and adherence to study protocol at assigned clinical sites. This role will be to work on medical device trials in Cardiology. How you will make an impact: Conducting Clinical Monitoring activities at sites across Germany Serve as key contact to assigned clinical sites throughout the study process Is accountable for achieving and reporting on agreed clinical milestones Supports study team in the interactions with Ethics Committees and Competent Authorities Participates actively to project team meetings, as required Close collaboration with internal stakeholders to ensure proper project conduct Assist in Providing site and Edwards personnel training including preparation/maintenance of study documents, completion of forms, understanding of examinations/assessments required Reporting site enrollment progress including device accountability and protocol deviations (inclusion/exclusion criteria, sequential enrollment) 6. Collecting completed Case Report Forms (CRF) and collecting, confirming and auditing supporting documentation. Processing adverse events Document procedural case observations for insights in investigating post procedural events Data review, safety reporting and complaint handling Identifying and reporting adverse events and device-related complications in accordance with regulatory and internal requirements Develop new improved processes and perform implementation Ensures Audit readiness for internal, external and site Audits Other incidental duties as assigned by management What you will need: Bachelor's Degree in a related field, and/or proven record of strong relevant experience. Previous related medical device and/or clinical experience required Previous clinical trial site monitoring experience in Germany within a Medical Device or Pharmaceutical setting. Experience of different types of monitoring visits and in different study stages. Quality assurance and regulatory compliance in a clinical research setting Driving licence required Fluency in both German and English language is essential What else we look for: Excellent communication and organizational skills Proven expertise in MS Office Suite and ability to operate general office machinery Good written and verbal communication skills, presentation, and interpersonal relationship skills including negotiating and relationship management skills Good problem-solving and critical thinking skills Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Cardiology and/or medical device study experience desirable. Driving licence required. This role will require regular travel within Germany (and some international travel). What is it like to work at Edwards Lifesciences in Germany? As a global leader in patient-focused medical innovations, we offer rewarding opportunities and exciting challenges in a truly international, dynamic and friendly work environment. We are committed to fostering a diverse and inclusive work environment where all employees can grow, personally and professionally. To achieve this, we offer on-the-job development, training opportunities and the support and guidance provided by dedicated employee groups (the Edwards Network of Women, Edwards Foundation charity team, sustainability activities, and others). Edwards Lifesciences in Germany also offers the following benefits: Competitive Compensation and Benefits package Flexible working hours, remote working Pension plan Risk Insurance Meal Benefits Service Awards Enhanced Leave Benefits Transportation Benefits Employee Stock Purchase Programme Employee Assistance Programme Comprehensive Wellness Programme including onsite gym, yoga classes and massage, preventive health checks, healthy lifestyle webinars, educational events, charity activities and much more. Benefits are regulated by an internal policy which contains the full details regarding the entitlement and conditions for the benefits. Benefits policy and components may vary by location.