Clinical Trials Auditor

Job overview

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.

Main duties of the job

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.

Detailed job description and main responsibilities

For further information on this role, please see the attached detailed Job Description and Person Specification.

• 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.