Clinical Trial Monitor

3 days left

24 Jul 2019
21 Aug 2019
Contract Type
Full Time
CK Group is recruiting for a Clinical Trial Monitor to join a world leading medical device company at their site based in Leeds on a 12 month contract basis. Hourly rate is GBP42 Ltd Company.

The Company:
Our client is a multinational medical devices, pharmaceutical and consumer packaged goods manufacturing company who offer the worlds most comprehensive portfolio of orthopaedic and neuro products and services for joint reconstruction, trauma, spine, sports medicine, neuro, cranio-maxillofacial, power tools and biomaterials.

The Location:
The role is based at our client's state of the art R&D and production facility in Leeds. This site is a short distance from the M621 and is easily commutable on public transport as it is a short distance from Leeds city centre.

The Role:
- Provide support to the implementation of the clinical research operations programme for all appropriate therapeutic areas for company Medical Devices in accordance with all applicable regulations for Medical Devices.
- Plan & implement 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.

Responsibilities include to:
- Provide support to the Clinical Trial Leader for agreed projects in the EMEA Clinical Research programme for the defined therapeutic area 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 for the approval of clinical investigations to regulatory authorities and ethics committees.
- Keep abreast of developments in clinical research and the clinical literature in therapeutic areas of responsibility.
- 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 Trial Leader & monitoring team.
- Maintain compliance with Company SOPs.
- Maintain a high standard of housekeeping and filing accuracy.
- Presentations on clinical study progress.

- Degree in Life Sciences, Health Sciences or related field to Biomedical Engineering or equivalent combination of education and experience.
- Strong experience of clinical trials monitoring in a medical company preferably with medical devices.
- Knowledge of clinical study design and management.
- Relevant experience in implementation of clinical research studies.
- Working knowledge of international regulatory requirements applicable to clinical research.
- Awareness of research ethics.
- Above average oral, written and communication skills.

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 46135 in all correspondence.