CK Group are recruiting for a Clinical Performance Specialist to join an assay development service at their site in Southampton on a fixed term contract basis.
Our clients are experts in real-time PCR, a molecular biology technique for detecting the presence of DNA/RNA and quantifying it. They have customers in many different industries including academia, research, healthcare, food industry and the veterinary industry selling to over 130 countries worldwide. They've launched a range of assays and products to support the need for mass COVID-19 testing.Clinical Performance Specialist Role:
This role supports clinical validation of the products and will be responsible for supporting the external Clinical Performance Studies and coordinating studies and reports.
Your duties will include to:
- Support external Clinical Performance Studies, ensuring that appropriate sites are selected, Clinical Performance study protocols and reports are written to a standard deemed appropriate for submission to regulatory bodies.
- Support the development of clinical and technical publications as well as scientific internal communications.
- Work closely with QA/RA in ensuring that projects are run to relevant quality standards (including the CE-IVD and FDA standards) for medical devices and in-vitro diagnostic equipment.
- • Manage and organize work on product validation in accordance with regulatory directives and ensure that the team has the resources (e.g. equipment, staff, training etc.) to properly perform validation and clinical performance tasks.
The ideal candidate for this Clinical Performance Specialist role will have the following skills and experience:
- Education to PhD level or equivalent in Molecular Biology/Biomedical/Biological Sciences or equivalent.
- Previous industry experience with a high level of molecular biology (PCR/qPCR) technical competence.
- Excellent organisational and communication skills, excellent attention to detail and the ability to multitask and work in a collaborative manner.
For more information or to apply for this Clinical Performance Specialist position, please contact Mary Bolt on 01246 457729 or email email@example.com, quoting job ref 51453.
It is essential that applicants hold entitlement to work in the UK.