Clinical Research Associate in Cardington

We are looking for a Clinical Research Associate to join our Clinicals team to support the execution of our clinical study programme. This will include study preparation, volunteer recruitment, study conduct, monitoring and tracking, and study close out activities on a full-time, permanent basis.

In the role you will manage clinical studies which will include:

• Contribution to study protocol development.
• Set-up activities, including sourcing and preparing study supplies, implementation of study processes, tracking tools and study documentation.
• Develop study training material and deliver training to study personnel.
• Contribute to study monitoring including generation of written reports and records relating to study conduct.
• Track study status and hold study conduct meetings, reporting study updates and activities to stakeholders.
• Manage, and contribute to study administration and execution activities (including recruitment and consent, packing, product testing, volunteer interviewing, volunteer payments, source data verification and query resolution).
• Arrange, conduct and report study team meetings.
• Maintain inspection-ready documentation including trial master files and support document archiving as appropriate.

You will provide support to the wider Clinical Research Team in delivering new and ongoing clinical studies ensuring compliance with study protocols and GCP is always met.

You will conduct in-house sample collection studies as requested to provide Clinical samples for the development and evaluation of SPD and/or competitor products, provide input to Clinical processes and Clinical team meetings whilst maintaining up to date working knowledge of GCP and other working standards and regulations related to Clinical research.

Previous experience of working in clinical research is essential, ideally within a diagnostic company or related biotech or pharmaceutical sector. You will hold a degree in a Life / Medical Science or related field.

You must be a highly motivated and organised individual with good attention to detail and have excellent record-keeping skills. You should have good communication skills, both written and verbal; previous experience of telephone work is desirable. You must be computer literate with a good working knowledge of Microsoft 365 (Outlook, Teams, Word, PowerPoint and Excel). Experience with IVD studies is preferred and knowledge of IVDR, ISO20916 and ISO13485 is desirable.

We can offer you:

• An excellent working environment.
• Hybrid working – three days a week in the office with two days a week working from home.
• 25 days paid annual leave plus bank holidays.
• Company pension scheme including competitive employer’s contribution.
• Private Medical Insurance package with additional medical cash plan scheme.
• Enhanced maternity and paternity pay.
• Company supported employee Health and Wellbeing programme.
• Life assurance.
• Free plentiful car parking and electrical car charging points.
• Beautiful parkland setting with excellent transportation links to Cambridge, Milton Keynes and London.

Swiss Precision Diagnostics GmbH (SPD) is a world leader in the research, design and marketing of advanced consumer diagnostic products. Our SPD research centre is at the cutting edge of innovation and is fully engaged in the development of reliable diagnostic products to empower women on their reproductive journey. We are committed to answering the needs of our existing and future consumers, through a continuous flow of new and innovative products.

Interested? Click apply and you will be redirected to our careers page to complete your application.