Clinical Trials Auditor

Job description

Job summary

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*

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.

About us

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.

Job description

Job responsibilities

For further information please refer to the job description and personal 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

Job description
Job responsibilities

For further information please refer to the job description and personal 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

Person Specification

Education/Qualifications

Essential

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

Experience

Essential

• 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

• Experience of working with non-commercial clinical studies

Skills Abilities/knowledge

Essential

• 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 Requirements

Essential

• 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

Person Specification
Education/Qualifications

Essential

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

Experience

Essential

• 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

• Experience of working with non-commercial clinical studies

Skills Abilities/knowledge

Essential

• 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 Requirements

Essential

• 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

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Employer details

Employer name

The Royal Marsden NHS Foundation Trust
Address

The Royal Marsden Sutton

Sutton

SM2 5PT

United Kingdom

Employer's website