Clinical Research Associate - Remote Monitoring Specialist

About the Role

We are seeking a dedicated Clinical Research Associate (CRA) to join our team in a remote capacity. As a Clinical Research Associate, you will be responsible for conducting on-site and remote monitoring visits to ensure compliance with regulatory standards and to enhance the quality of clinical trials. This position offers the opportunity to work with a global leader in medical technologies, Teleflex, and contribute to improving healthcare outcomes.

What You'll Do

• Conduct monitoring visits in accordance with the monitoring plan and Teleflex procedures.
• Collaborate with Research Coordinators and Investigators to schedule and execute monitoring visits, including site qualification, initiation, and closure.
• Evaluate the quality and integrity of site practices, escalating issues as necessary.
• Prepare thoroughly for monitoring visits to maximize efficiency and effectiveness.
• Document findings and action items clearly in Monitoring Visit Reports (MVRs) and follow up on resolutions.
• Assist in training and mentoring Clinical Studies personnel for both remote and on-site monitoring.
• Ensure compliance with national and local safety reporting requirements.
• Support the Clinical Project Manager with various study-related tasks, including audits and investigator meetings.

Requirements

• Bachelor's or Graduate degree in life sciences, nursing, or a related field.
• A minimum of two years of experience as a Clinical Research Associate, preferably in the medical device or pharmaceutical industry.
• Strong understanding of MDR, ISO 14155, and ICH/GCP guidelines.
• Excellent organizational skills and attention to detail.
• Fluency in German and English, both written and spoken.
• Proficient in using MS Word and Excel for documentation and reporting.
• Ability to work independently and manage time effectively.
• Experience with remote monitoring and the ability to adapt to shifting priorities.

Nice to Have

• Knowledge of Vascular Interventional Cardiology and/or Peripheral Vascular Intervention.
• Experience in training site staff on protocols and regulations.
• Previous involvement in safety inspections and audits.

What We Offer

• A competitive salary starting at €65,000 per year, with potential for overpayment based on experience.
• Flexible remote work arrangements.
• Opportunities for professional development and training.
• A diverse and inclusive workplace culture.
• Support for home office setup, including necessary equipment.
• Health and wellness benefits.
• Participation in a company that values innovation and diversity.
• Commitment to improving the health and quality of life for patients worldwide.