Clinical Research Associate (CRA)

Role Summary

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.

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 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

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