Clinical Research Associate, Senior CRA

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

📋 Description

• Carry out clinical monitoring tasks at designated clinical sites throughout Germany.

• Act as the primary contact for assigned clinical sites during the entire study cycle.

• Meet and communicate agreed-upon clinical milestones.

• Assist the study team in interactions with Ethics Committees and Competent Authorities.

• Engage in project team meetings.

• Work collaboratively with internal stakeholders to ensure effective project execution.

• Deliver training to site and Edwards personnel.

• Prepare and maintain study documentation while completing necessary forms.

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

• Gather completed Case Report Forms and audit supporting documentation.

• Handle adverse event processing.

• Record procedural case observations to examine post-procedural events.

• Conduct data reviews, safety reporting, and manage complaints.

• Identify and report adverse events and device-related complications according to regulatory and internal standards.

• Create and implement enhanced processes.

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

• Perform additional incidental tasks as assigned by management.

⛳️ Requirements

• Bachelor’s Degree in a related discipline, along with a demonstrated history of relevant experience.

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

• Experience monitoring clinical trial sites in Germany within a Medical Device or Pharmaceutical context.

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

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

• A valid driving license is necessary.

• Proficiency in English and the relevant local language, either French or German, is crucial.

• Strong communication and organizational abilities.

• Proficient in MS Office Suite and capable of operating general office equipment.

• Effective written and verbal communication, presentation, and interpersonal skills.

• Skills in negotiation and relationship management.

• Strong problem-solving and critical thinking abilities.

• Capacity to follow company policies and requirements, including Environmental Health & Safety regulations.

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

🏝️ Benefits

• Opportunities for on-the-job development.

• Access to training programs.

• Support and mentorship from dedicated employee groups.

• Competitive compensation and benefits package.

• Comprehensive Wellness Programme.

• A diverse and inclusive work environment.

• Opportunities for both personal and professional growth.