Hobson Prior are looking for a CRA to join a medical device company who focus on innovative medical devices and solutions in orthopaedics, spinal care and neuroscience. You will be accountable for providing support to the implementation of the clinical research operations programme for all appropriate therapeutic areas. This position will entail UK wide site visits, but homebased when not on site.
- Deliver support to Clinical Trial Leader for agreed projects in the EMEA Clinical Research programme for the defined therapeutic area.
- Maintain the highest ethical, clinical and scientific standards making sure that both the safety and well-being of all trial participants and good/rigorous scientific practice.
- Manage the inventory of Investigational Products and control the issue of investigational products to approved sites where necessary.
- Keep well-informed 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 up-to-date of developments in clinical research and the clinical literature in therapeutic areas of responsibility.
- Support 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.
- Monitor defined clinical studies in accordance with Good Clinical Practice requirements and provide regular feedback to company personnel on the progress of trials.
- Partake 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.
- Must be highly responsible and capable of seeing each project to its conclusion.
- 1st Degree in Life Sciences, Health Sciences or related field to Biomedical Engineering or equivalent combination of education and experience.
- Minimum of 5 years’ experience of clinical trials monitoring in a medical company preferably with medical devices.
- You will understand 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.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.