Clinical Trials Auditor

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 the 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 the audit programme is delivered successfully.
• Categorise findings in accordance with Trust standards and, where necessary, escalate major and critical findings.
• Facilitate meetings with research team members where necessary to ensure findings are communicated appropriately.

Education / Qualifications:

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

Experience:

• Experience of working to UK Clinical Trials Regulations.
• Experience of working in the NHS or a 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:

• 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 using PC‑based Windows and Microsoft Office software including Access & PowerPoint.
• Ability to work proactively to identify new risks and issues and flag them 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 one’s own initiative.
• Proven ability to organise own work in a 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 under‑represented 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, recognising that greater diversity and inclusion leads to a greater positive impact for the people we serve.

Flu Vaccination – What We Expect of Our Staff:

At The Royal Marsden we must protect an immune‑compromised patient population from the flu virus. It is the expectation that all patient‑facing staff have an annual flu vaccination, which is provided free of charge by the Trust.