Clinical Research Associate / Senior CRA

Edwards Lifesciences; France; Remote; EUR 60,000 - 90,000; Full time

Job summary

Edwards Lifesciences seeks a Clinical Monitoring professional to oversee site activities for medical device trials in Cardiology. The role involves monitoring visits across Germany and collaboration with Ethics Committees, regulatory bodies, and project teams.

The ideal candidate has a Bachelor's degree in a related field, clinical trial monitoring experience, and fluent English plus a local language. Travel within Germany and broader Europe is expected.

Qualifications

• Bachelor's Degree in a related field or equivalent experience.
• Medical device and/or clinical experience required.
• Clinical trial site monitoring experience in Germany within a medical device or pharma setting.
• Experience with different types of monitoring visits and study stages.
• Quality assurance and regulatory compliance in a clinical research setting.
• Driving licence required.
• Fluency in English and a local language (French or German as applicable).

Responsibilities

• Conduct clinical monitoring activities at sites across Germany.
• Serve as key contact to assigned clinical sites throughout the study process.
• Be accountable for achieving and reporting on agreed clinical milestones.
• Support study team in interactions with Ethics Committees and Competent Authorities.
• Participate in project team meetings and collaborate with internal stakeholders.
• Assist in site and Edwards personnel training and document preparation.
• Collect and audit Case Report Forms and supporting documentation.
• Process adverse events and report device-related issues.
• Ensure audit readiness for internal, external and site audits.
• Identify and report adverse events and device-related complications per regulatory requirements.
• Develop and implement new processes and improvements.

Skills

communication

organizational skills

ms office suite

problem solving

interpersonal skills

negotiation

fluent English and local language

driving licence

Education

Bachelor's degree

Tools

MS Office Suite

Job description

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.

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

• Germany - based around Munich, Frankfurt, Hamburg, Stuttgart, Cologne and surrounding areas
• France - Flexible locations

Our clinical monitoring roles require travel national travel for monitoring visits, as well as some travel within the wider European region.

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 (required):

• 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 English and local language (French or German as applicable) is essential.

What else we look for (preferred):

• 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.