Senior CRA - Inverness
CK Group is recruiting for a Clinical Research Monitor to join a world leading medical device company at their site based in Inverness on a 12 month contract basis.
The Client: Our client is part of a family of companies owned by one of the world largest pharmaceutical companies. They are committed to improving the quality of life for people with diabetes. That is why they offer a range of blood glucose monitoring products and Customer Care services to meet these different needs more closely. In the UK and Ireland, many thousands of people with diabetes depend on their products for simple testing and accurate results. Their medical devices are very easy-to-use, reliable and accurate, making life easier when it comes to blood glucose monitoring.
The Location: Based at our client's site on Scotland's northeast coast, Inverness is the largest cosmopolitan city and the cultural centre of the Scottish Highlands. This location has road links to the A9 south connecting Inverness with Edinburgh, Scotland's capital, and the bustling city Glasgow, as well as the A96 which links Inverness to the seaside town of Nairn and to Aberdeen. Inverness also offers good rail links to Aberdeen, Glasgow and Edinburgh, and finally if you're flying in, Inverness Airport is situated just 20 minutes from the city centre!
The Role: Providing support to the implementation of the clinical research operations programme for all appropriate therapeutic areas for in accordance with all applicable regulations for Medical Devices. Planning & implementing a programme of monitoring for all international regulatory and post marketing clinical research studies and maintain the highest ethical, clinical and scientific standards ensuring both the safety and well being of all trial participants, and good/rigorous scientific practice.
- Provide support to Clinical Operations for agreed projects by monitoring and reporting on studies progress in accordance with all Corporate and Statutory requirements to agreed timescales.
- Maintain the highest ethical, clinical and scientific standards ensuring both the safety and well being of all trial participants and good/rigorous scientific practice.
- Keep abreast of international legislation and other requirements concerning clinical research. Prepare and submit submissions or amendments for the approval of clinical investigations to regulatory authorities and ethics committees.
- Assist in the preparation of consent documentation where required for the proper scientific evaluation of new or existing products in accordance with all ethical and regulatory requirements for Medical Devices in respect of applicable European and International Medical Devices Regulations.
- Monitor defined clinical studies in accordance with Good Clinical Practice requirements and provide regular feedback to company personnel on the progress of trials.
- Administer the inventory of Investigational Products and control the issue of investigational products to approved sites where necessary.
- Participate in project teams and build relationships with investigators, regulatory bodies and appropriate company personnel as required regarding clinical research issues, working as directed by Clinical Operations team management.
- Maintain compliance with Company SOPs.
- Maintain a high standard of housekeeping and filing accuracy.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Degree in Life Sciences, Health Sciences or related field to Biomedical Engineering or equivalent combination of education and experience.
- Experience of clinical trials monitoring in a medical company preferably with medical devices.
- Knowledge of clinical study design and management.
- Above average oral, written and communication skills.
For more information or to apply for this position, please contact Lucy Stendall or Jenni Woolley on 01246 457733 / 01438 768 710 or email firstname.lastname@example.org. Alternatively please click the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA43116 in all correspondence.