Clinical Research Associate / Senior CRA

This is a fully remote position, open to applicants in Germany, +1 more country.

📋 Description

• Conduct clinical monitoring activities at various sites throughout Germany.

• Act as the primary contact for designated clinical sites during the study process.

• Meet and report on established clinical milestones.

• Support the study team with interactions involving Ethics Committees and Competent Authorities.

• Actively engage in project team meetings.

• Work in close collaboration with internal stakeholders to ensure effective project execution.

• Assist in training for both site personnel and Edwards staff.

• Prepare and maintain study documentation and complete necessary forms.

• Report on site enrollment progress, device accountability, and any protocol deviations.

• Gather completed Case Report Forms and audit supporting documents.

• Manage adverse event processing.

• Document procedural observations for investigations of post-procedural events.

• Conduct data review, safety reporting, and complaint management.

• Identify and communicate adverse events and device-related complications.

• Develop and implement enhanced processes.

• Ensure readiness for internal, external, and site audits.

• Perform other incidental tasks as assigned by management.

⛳️ Requirements

• Bachelor's Degree in a relevant field, and/or a proven track record of substantial related experience.

• Prior experience in the medical device and/or clinical field is mandatory.

• Experience in clinical trial site monitoring in Germany within a Medical Device or Pharmaceutical context is required.

• Familiarity with various types of monitoring visits and different phases of studies.

• Knowledge of quality assurance and regulatory compliance within a clinical research environment.

• A valid driving license is necessary.

• Proficiency in both English and the local language (French or German as applicable) is essential.

• Exceptional communication and organizational abilities.

• Proven proficiency in MS Office Suite and the capability to operate general office equipment.

• Strong written and verbal communication skills, along with effective presentation and interpersonal relationship skills, including negotiation and relationship management capabilities.

• Good problem-solving and critical thinking skills.

• Adhere to all company policies and requirements, including pandemic protocols and Environmental Health & Safety regulations.

• Experience in cardiology and/or medical device studies is preferable.

🏝️ Benefits

• Full-time employment.

• Opportunities for national travel and some travel within the broader European region.

• Training opportunities, including site and Edwards personnel training.