Clinical Research Associate Specialist
2 days ago
We are seeking a highly skilled Clinical Research Associate to join our team at Exstent Limited. This is a full-time position based in the Tewkesbury office, with opportunities for home working.
The successful candidate will be responsible for managing the ExoVasc Registry and handling of clinical data, ensuring continued compliance with post-market surveillance requirements.
Responsibilities:
- Design, implement, operate, and manage a Clinical Registry for use with the ExoVasc Personalised External Aortic Root Support.
- Determine data collection requirements to fulfil regulatory requirements.
- Manage the collection of relevant patient data from customers, including surgeons and distributors.
- Process and analyse clinical data to demonstrate safety and effectiveness of the ExoVasc device.
- Co-write clinical reports to meet regulatory requirements.
- Liaise with clinicians to provide information for clinical papers.
- Operate within Exstent's Quality Management System.
- Liaise with the Registry software developer/supplier.
Requirements:
- Educated to degree level, ideally with a scientific background.
- Knowledge of clinical reporting requirements for medical devices.
- Experience in clinical data analysis, reviewing clinical literature, and writing reports.
- Ability to travel within Europe and globally.
- Excellent communication skills.
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