Clinical Research Associate

Role Summary

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.

Key Responsibilities

  • 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.


  • Integrity
  • Quality
  • Flexibility
  • Creativity
  • Respect

Accountable To

Clinical Evidence Manager

Responsible For

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
Please note we will not consider unsolicited CVs from agencies.

Application Form

Please upload your CV.