Clinical Trials Auditor

The Royal Marsden NHS Foundation Trust; Sutton; On-site; GBP 42,000 - 56,000; Full time

Job summary

The Royal Marsden NHS Foundation Trust, based in Sutton, is seeking a clinical research professional to maintain MHRA inspection readiness and support regulatory compliance and high-quality research across the Trust and Institute of Cancer Research (ICR). The role involves risk-based audits, quality-by-design approaches, CAPA oversight, SOPs and QMS development, and delivering training to research teams.

Applicants should have experience in clinical trials conduct and be familiar with the

Qualifications

• Clinical trials conduct experience required.
• Familiarity with the regulatory environment surrounding clinical trials.
• Experience with audit processes and CAPA management is desirable.

Responsibilities

• Maintain MHRA inspection readiness and oversee regulatory compliance.
• Lead risk-based audit programmes and contribute to QMS and SOPs.
• Design and deliver training to research teams and liaise with internal and external stakeholders.
• Support development and maintenance of SOPs and CAPA records.

Skills

Clinical research experience

Regulatory compliance knowledge

GCP guidelines

Audit experience

Job description

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 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.

*IMMEDIATE START PREFFERED*

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 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.

For further details / informal visits contact: Name: Joanna Soltysinska Job title: Acting Clinical Research Quality Assurance Manager Email address: [e-mail]