We have a vacancy for an experienced Clinical Research Associate to join our Clinical Investigations team. You will mainly be working from home, but will need a full driving licence to travel throughout the UK and will be required to attend our Leeds based site at least once a month.
Xiros is an award-winning international medical devices group specialising in sports medicine. Accredited with the elite Investors in People Gold Award, our mission is to create the highest quality, innovative medical devices, with a commitment to developing our people.
- Organise and monitor clinical investigations, delegating to third parties such as Clinical Research Organisations (CROs) and Clinical Trials Units (CTUs) as required. Co-ordinate studies with host centres, surgeons and administrators and ensure that contracted deliverables are delivered on time and to correct quality.
- Develop and write clinical investigation protocols, clinical investigation reports, case report forms (CRFs), investigator brochures and other clinical trial documentation. Ensure that processes for contracts and study set-up are followed without delay.
- Manage ethical approval processes and regulatory authority applications/approvals. Monitor relevant external parties to ensure these progress smoothly.
- Identify and assess the suitability of investigators and facilities to use as the clinical trial site.
- Be responsible for site set up, training, monitoring and close out.
- Be accountable for devices and inventories.
- Verify and review adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol.
- Archive study documentation and correspondence.
- Manage data including arranging statistical analysis.
- Provide an up to date overview on a weekly basis of progress on all of the above and act promptly on any Amber/Red status activities.
- Assist in the development and drafting of trial methodologies (Standard Operating Procedures).
Essential Experience, Knowledge and Qualifications
- Degree in science, clinical or health-related field or a licenced health-care professional such as registered nurse; or equivalent work experience required.
- Experience of managing clinical investigations.
- Working knowledge of EU Directives/UK regulations/ISO 14155 regulations, device development and clinical monitoring procedures.
Desirable Experience, Knowledge and Qualifications
- Project or Programme Management qualifications/training.
- Experience in medical devices and knowledge of ISO 13485:2016.
- Working knowledge of US regulations.
Essential Skills and Behaviours
- Good organisational skills and attention to detail.
- Excellent interpersonal skills and the ability to work as part of a team.
- Excellent verbal and written communication skills and presentation skills.
To Apply: Please send your CV and covering letter to Kate.deJuan@xiros.co.uk