Clinical Research Associate / In-House CRA

Edwards Lifesciences Corporation; Deutschland; Hybrid; EUR 50.000 - 90.000; Vollzeit

Zusammenfassung

An established industry player is seeking a dedicated In-House Clinical Research Associate to join their innovative team. This role is pivotal in ensuring that clinical trials are conducted in compliance with regulatory standards, while also providing an exciting opportunity to contribute to groundbreaking medical innovations. You will be responsible for managing study documentation, supporting interactions with Ethics Committees, and collaborating with cross-functional teams to enhance operational efficiency. Join a dynamic work environment that values diversity and offers numerous benefits, including flexible working hours and comprehensive wellness programs. Take the next step in your career and make a meaningful impact on patient care.

Leistungen

Competitive Compensation and Benefits package

Flexible working hours

Remote working

Pension plan

Meal Benefits

Service Awards

Transportation Benefits

Employee Stock Purchase Programme

Employee Assistance Programme

Comprehensive Wellness Programme

Qualifikationen

• 3+ years of experience in clinical research or site management.
• Experience in quality assurance/control and regulatory compliance.

Aufgaben

• Ensure compliance with regulatory requirements during clinical trials.
• Identify discrepancies in study documentation and develop preventive processes.

Kenntnisse

Clinical Research

Regulatory Compliance

Quality Assurance

Problem Solving

Communication Skills

Ausbildung

Bachelor's degree in a related field

Tools

Electronic Data Capture Systems

MS Office Suite

CTMS

eTMF

Jobbeschreibung

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

In the role of In-House Clinical Research Associate (CRA), you will ensure that clinical trials are conducted and reported in accordance with all applicable regulatory requirements.

How you'll make an impact:

• Perform study start-up and conduct activities including ICF review to ensure compliance with regulatory requirements
• Create study-specific essential document lists and manage study progress by communicating the status of activities to relevant stakeholders
• Identify and investigate discrepancies in study documentation by applying clinical protocol knowledge, GCP, and ISO14155 guidelines, and develop processes to prevent recurrence throughout all study phases
• Conduct in-house and (if applicable) on-site reviews of clinical documentation and participate in internal and competent authority audits to ensure Trial Master File (TMF) documents are compliant with Good Documentation Practices, Edwards SOPs, and global regulatory requirements
• Support the study team in interactions with Ethics Committees and Competent Authorities
• Participate in project team meetings, as required
• Assess current processes, identify opportunities for improvement, and propose solutions to enhance efficiency within and across related functional areas
• Partner with cross-functional teams (e.g., clinical data management, field teams) on query management, data review, and resolution
• Report on site enrollment progress, including device accountability and protocol deviations (e.g., inclusion/exclusion criteria, sequential enrollment)
• Perform other incidental duties as assigned by management

What you'll need (Required):

• Bachelor's degree in a related field
• Minimum of 3 years of experience in clinical research (site management, clinical project management, monitoring, and/or as a CRC)
• Experience with quality assurance/control and regulatory compliance or field monitoring in the healthcare industry
• Experience working in a medical device or regulated industry (preferred)
• Experience with electronic data capture systems (required)

What else we look for (Preferred):

• Proficiency in MS Office Suite and clinical systems such as CTMS (Clinical Trial Management System) and eTMF (electronic Trial Master File)
• Strong written and verbal communication, presentation, and interpersonal skills, including negotiation and relationship management
• Good problem-solving and critical thinking abilities
• Strong understanding of cardiovascular anatomy, pathology, and physiology
• Moderate knowledge of domestic/international medical device regulatory guidelines relevant to clinical protocols
• Understanding of regulatory submissions, reporting, and audit processes
• Ability to manage confidential information with discretion
• High attention to detail
• Ability to work professionally across all organizational levels
• Strong time management skills with the ability to prioritize tasks in a fast-paced environment
• Comfortable working in team settings, including cross-functional collaboration and representing the organization in specific projects
• Ability to build and maintain effective internal and external working relationships

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.