Clinical Trials Auditor | The Royal Marsden NHS Foundation Trust

The post-holder, as part of the GCP and Regulatory Compliance Team, will be responsible for maintaining MHRA inspection readiness and supporting regulatory compliance and high-quality research across the Trust and ICR. This will be achieved through a comprehensive risk-based audit programme, a quality-by-design approach to clinical research and clinical investigation protocols, oversight of CAPA management, contribution to the development and maintenance of SOPs and the quality management system, and the design and delivery of training to research teams. The post-holder will liaise with staff within the Royal Marsden and Institute of Cancer Research (ICR) staff, at all levels including senior medical, scientific, statistical, nursing and administrative staff. They will also liaise with the Chairman and members of the Committee for Clinical Research as well as external organisations within both the public and private sectors including Medicines & Healthcare Products Regulatory Agency and other regulatory bodies The role requires a clinical research professional who has experience in clinical trials conduct and familiarity with the regulatory environment surrounding clinical trials. The post holder will be based at Sutton with occasional travel to Chelsea and /or other UK clinical trial sites as the role requires.,

• Develop, in collaboration with GCP and Regulatory Compliance Team, the risk based audit programme.
• Continually monitor and assess emerging risks associated with research portfolio and perform triggered audits as required.
• Plan, undertake and produce audit reports both independently and as part of the GCP and Regulatory Compliance Team.
• Create and develop the tools necessary to undertake and report audits.
• Foster positive working relationships with research stakeholders to ensure audit programme is delivered successfully.
• Categorise findings in accordance with Trust standards and escalate major and critical findings where necessary.
• Facilitate meetings with research team members where necessary to ensure findings are communicated appropriately.
  
  Disability Confident
About Disability Confident A Disability Confident employer will generally offer an interview to any applicant that declares they have a disability and meets the minimum criteria for the job as defined by the employer. It is important to note that in certain recruitment situations such as high-volume, seasonal and high-peak times, the employer may wish to limit the overall numbers of interviews offered to both disabled people and non-disabled people. For more details please go to .

The Royal Marsden NHS Foundation Trust is a world-leading cancer centre. Our role is to offer our patients the best cancer care available anywhere in the world, and to continue to make a global contribution to finding better ways of diagnosing and treating cancer. We employ over 4,500 staff in a diverse range of careers including nursing, medical, science, radiography, pharmacy, occupational therapy, finance and administrative services. We have two hospitals - one in Chelsea, London, and one in Sutton, Surrey - as well as a Medical Daycare Unit in Kingston Hospital. At The Royal Marsden, we deal with cancer every day, so we understand how valuable life is. When people entrust their lives to us, they have the right to demand the very best. That's why the pursuit of excellence lies at the heart of everything we do. At the heart of the hospital is our dedicated team. We offer a stimulating and dynamic working environment, a wide range of staff benefits, learning and development opportunities and clear career pathways. There are opportunities to work flexibly across a range of areas and specialities and we welcome flexible working requests from point of hire to support employees work life balance. We are looking for employees who aspire to excellence, share our values and can play a crucial role in our on-going achievements.