Clinical Research Quality Assurance Lead

King's College Hospital NHS Foundation Trust; Greater London; On-site; GBP 38,000 - 47,000; Full time

Job summary

King's College Hospital NHS Foundation Trust is seeking a Quality Assurance Officer to support and maintain the quality management system for clinical research in the R&D Department. The role ensures compliance with GxP, regulatory frameworks, and data protection obligations across the Trust.

The post holder will coordinate QA activities, develop SOPs, and maintain quality records ready for inspection. They will assist with inspections and audits and contribute to ongoing improvement of research

Qualifications

• Relevant degree or professional qualification or equivalent experience.
• Good Clinical Practice training.
• Excellent oral and written communication skills.
• Experience in NHS or HEI research settings.
• Basic understanding of medical terminology.
• Risk and incident management experience in NHS or pharmaceutical settings.

Responsibilities

• Set up and manage the quality control of clinical research activity within the R&D Office.
• Develop, implement, review and verify R&D working practices and SOPs, ensuring that Regulatory and Trust requirements are encapsulated.
• Implement and maintain office systems to manage working practices and policies within the Trust.
• Maintain precise and accurate quality management records ready for inspection by regulatory authorities and Sponsors on demand.
• Prepare reports of InPhase incidents and monitor CAPA.
• Assist in hosting regulatory inspections and external audits as required.
• Manage the Trusts research audit and monitoring programme and undertake monthly GCP and research governance audits.

Skills

Communication skills

Regulatory knowledge

NHS/HEI experience

Medical terminology

Quality assurance

Education

Relevant degree or professional qualification

Good Clinical Practice training

Job description

King's College Hospital NHS Foundation Trust is seeking a Quality Assurance Officer to support and maintain the quality management system for clinical research in the R&D Department. The role ensures compliance with GxP, regulatory frameworks, and data protection obligations across the Trust.

The post holder will coordinate QA activities, develop SOPs, and maintain quality records ready for inspection. They will assist with inspections and audits and contribute to ongoing improvement of research