Clinical Research Associate
5 days ago
Clinical Research Associate
Position Description
The Clinical Research Associate is responsible for managing the ExoVasc® Registry and handling of clinical data.
The Clinical Research Associate is a full-time position, based from the Tewkesbury office of Exstent Limited, with opportunity for home working, reporting to the Technical Director.
Detailed Responsibilities:
1. The design, implementation, operation and management of a Clinical Registry for use with the ExoVasc Personalised External Aortic Root Support to ensure continued compliance with post market surveillance requirements of relevant national and international standards; including in particular ISO 13485, MDSAP and GcP (Good Clinical Practice).
2. Determination of data collection requirements that will provide the necessary input to fulfil regulatory requirements.
3. Management of the collection of relevant patient data from Exstent’s customers, including surgeons and distributors in an approach that is efficient for both customers and the company.
4. The processing and analysis of clinical data to demonstrate safety and effectiveness of the ExoVasc device.
5. Co-writing of clinical reports that can be used to fulfil regulatory requirements in countries in which the company markets its products, including FDA approval in the USA.
6. Working with clinicians to provide information for clinical papers that can be published in medical and scientific journals or presented at meetings or conferences.
7. To operate within Exstent’s Quality Management System in line with regulatory requirements for medical devices.
8. To liaise with the Registry software developer / supplier to ensure the registry functions as required and has an intuitive user interface.
9. To liaise with Exstent’s clinical / surgical team on the presentation of data.
10. Maintains current awareness of national and international standards and best practice relevant to the company and its products.
11. Works with the Technical Director and QARA Director on the handling of case report forms in accordance with regulatory requirements for Medical Devices.
Personnel Specification
1. Educated to degree level, ideally with a scientific background.
2. Knowledge of clinical reporting requirements for medical devices, including GcP (Good Clinical Practice), MDSAP and European regulations governing medical devices.
3. Experience in clinical data analysis, reviewing clinical literature and writing reports
4. Ability to travel within Europe and globally where necessary to fulfil responsibilities in each of the countries in which the company operates.
5. Ability to communicate effectively and appropriately both internally and with healthcare professionals.
6. A willingness to work with a small team in a growing organisation and play a full part in the development of the company.
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