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

• 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.

Person specification

Education / Qualifications

Essential criteria

• Educated to degree level or equivalent experience in clinical research
• Recognised GCP training

Experience

Essential criteria

• Experience of working to UK Clinical Trials Regulations
• Experience of working in the NHS or relevant clinical / research environment
• Experience of monitoring or auditing clinical trials
• Experience of working across organisational boundaries with multidisciplinary teams

Desirable criteria

• Experience of working with non-commercial clinical studies

Skills, Abilities & Knowledge

Essential criteria

• Detailed knowledge of UK Clinical trial regulations, GCP and regulatory framework
• Ability to read and understand clinical research protocols
• Ability to summarise and explain complex issues to both technical and non-technical audiences
• Willing and able to coach and train others
• Excellent administrative and organisational skills
• Proficient in the using PC based Windows and Microsoft Office software including Access & PowerPoint
• Ability to work in a proactive manner to identify new risks and issues and flag upwards appropriately
• Ability to work well within a multi-disciplinary team environment
• Able to work under pressure, methodical in approach, with effective problem-solving ability
• A high level of accuracy and attention to detail
• Ability to work on own initiative
• Proven ability to organise own work in busy work environment and time critical situations

Other

Essential criteria

• Flexible to meet the needs of the service (e.g., working ad hoc to support regulatory inspections)
• Able to work on both sites and to be flexible to meet the needs of the role

The Royal Marsden values diversity and is committed to the recruitment and retention of underrepresented minority groups. We particularly welcome applications from Black, Asian and minority ethnic candidates, LGBTQ+ candidates and candidates with disabilities.

As a Disability Confident Employer, we are working to create a workplace that enables all staff to reach their full potential. We are committed to this because we know that greater diversity and inclusion will lead to an even greater positive impact for the people we serve.

Due to the high volumes of applications we receive, we reserve the right to close any adverts before the published closing date once we have received a sufficient number of applications. We advise you to submit your application as early as possible to prevent disappointment. Please ensure your information is accurate to avoid errors with processing your application

Flu Vaccination – What We Expect of our Staff

At The Royal Marsden we have an immune compromised patient population who we must protect as much as we can against the flu virus. Each year, seasonal flu affects thousands of people in the UK. Occurring mainly in winter, it is an infectious respiratory disease capable of producing symptoms ranging from those similar to a common cold, through to very severe or even fatal disease.

The wellbeing of our staff and patients is of the upmost importance to us, and it is the expectation of The Royal Marsden that all patient-facing staff have an annual flu vaccination, provided free of charge by the Trust.

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