We have an exciting opportunity for an experienced individual to join us as a Clinical Research Associate.
We are a multi-award-winning medical devices company specialising in the design and manufacture of textile-based implantable medical devices. Our mission is to create the highest quality, innovative medical devices and we are committed to putting people first and developing them. We are a multiple Queens Export Award winner and were ranked in the top 100 ‘Best Companies’ to Work for 2018.
- 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 Behaviour
- 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.
- Willing to travel more than 50% of the time.
Clinical Evidence Manager
No direct reports
Starting Salary: From £38,250 – £45,000 + highly competitive range of core and flexible benefits
Closing Date: Friday 1 November 2019
To apply for this role please send your CV and covering letter directly to email@example.com
Please note we will not consider unsolicited CVs from agencies.