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.

Values

  • 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 hr@xiros.co.uk
Please note we will not consider unsolicited CVs from agencies.

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