Position Summary

The Clinical Research Associate (CRA) is responsible for scheduling and conducting on-site and remote monitoring visits in compliance with applicable regulatory standards (MDR, ISO 14155, ICH/GCP guidelines, Teleflex procedures and IRB/EC policies and procedures). The CRA conducts monitoring visits as identified by the monitoring plan, study team or department needs to evaluate data accuracy and subject safety required by review of regulatory documents, medical records, reported data and device storage, if applicable. The CRA must be able to identify issues, present findings to the site staff, provide retraining if needed, provide problem solving strategies and communicate findings to the study team and department management via escalation of issues and/or within the monitoring visit report. The CRA has a minimum of 2 years of work experience as a clinical trial monitor. The CRA assists the Management Team with training needs.

Principal Responsibilities

• Conduct site qualification, initiation, monitoring, and close-out visits (on-site)
• Ensure data quality, subject safety, and compliance with ISO 14155, and MDR
• Collaborate closely with investigational sites and internal project teams
• Prepare monitoring visit reports and follow up on action items
• Support safety reporting activities, audits, and regulatory inspections
• Train and support site staff as well as newly hired CRA colleagues

Education / Experience Requirements

• Bachelor's or Graduate degree in life sciences, nursing or other health related disciplines or a comparable qualification.
• Minimum two years of on-site monitoring research experience as a CRA in the medical device or pharmaceutical industry or with a CRO.
• High level of attention to detail and strong organizational ability paired with excellent people skills.
• Excellent clinical trial monitoring skills.
• Previous knowledge of Vascular Interventional Cardiology and/or Peripheral Vascular Intervention is an advantage.

Specialized Skills / Other Requirements

We offer a permanent position classified in Group E in accordance with the Austrian Collective Agreement for Employees and Apprentices in Commercial Enterprises.
The minimum monthly gross salary under the collective agreement is € 3.437 ,– gross (full-time, 38.5 hours per week).
We are committed to offering a competitive salary and therefore guarantee a minimum annual gross salary of € 65.000, with the possibility of overpayment depending on your qualifications and experience

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