King's College London

About us:

The King’s Health Partners Clinical Trials Office (KHP-CTO) is a collaboration between King’s College London, Guy’s and St Thomas’ NHS Foundation Trust, King’s College Hospital NHS Foundation Trust and South London and Maudsley NHS Foundation Trust (the Partner Organisations). It is set up to provide a single interface for those wishing to conduct clinical trials within the Partner Organisations, and to ensure that there are common, efficient processes for the set up and administration of clinical trials.

About the role:

The post-holder will be responsible for overseeing the monitoring and quality assurance of non-commercial clinical trials sponsored or co-sponsored by King’s Health Partners (KHP) Partner Organisations: Guy’s and St Thomas’ NHS Foundation Trust, King’s College Hospital NHS Foundation Trust, and South London and Maudsley NHS Foundation Trust.  The post-holder will ensure that all activities are conducted in accordance with applicable legislation, ICH GCP E6 guidelines, and applicable institutional policies. Working as part of the KHP-CTO Non-Commercial Team, the post-holder will ensure that the following sponsor responsibilities (delegated to the KHP-CTO) for clinical oversight, safety reporting, and data integrity; are discharged to the highest standards of quality and compliance.

The post-holder will lead and develop a team of Clinical Research Associates and Clinical Trial Administrators, ensuring a consistent, risk-based approach to trial monitoring, quality control and issue management. They will work closely with the Non-Commercial Trials Manager, investigators, and research delivery teams across the Partner Organisations to promote a culture of continuous improvement, support regulatory inspection readiness, and safeguard the rights, safety and wellbeing of research participants, while maintaining the credibility and reputation of the KHP-CTO as a centre of excellence for clinical research.

This is a full-time post and you will be offered a 12-month fixed term contract

About you:

To be successful in this role, we are looking for candidates to have the following skills and experience:

Essential criteria

1.      Educated to postgraduate (master’s degree) level in a health-related area or equivalent professional experience

2.      Comprehensive knowledge and understanding of standards and legislation that govern research in the NHS and academia

3.      Comprehensive knowledge of clinical trial regulations, good clinical practice guidelines and other regulatory frameworks and their implication for health research.

4.      Excellent communication skills and the ability to apply these to create technical documents (e.g. regulatory reports, CAPAs, SOPs) and to correspond with research staff at all levels in an appropriate way

5.      Ability to listen to others and use critical questioning techniques to identify core issues to negotiate a path forward that meets the needs of all stakeholders

6.      Experience supporting regulatory inspections, ideally by the MHRA

7.      Experienced line manager who can work flexibly, and who has a positive approach to work

8.      Ability to ensure quality related issues are identified and followed up in a timely manner

Desirable criteria

1.      Quality Assurance/ Governance related professional qualifications.

2.      Proven experience of working within a quality assurance role, either within academia, the NHS or the pharmaceutical industry

3.      Experience of managing risk-based systems

4.      Extensive experience of clinical trial monitoring and/or audit

Downloading a copy of our Job Description

Full details of the role and the skills, knowledge and experience required can be found in the Job Description document, provided at the bottom of the next page after you click “Apply Now”. This document will provide information regarding the criteria to be assessed at each stage of the recruitment process.

We pride ourselves on being inclusive and welcoming. We embrace diversity and want everyone to feel that they belong and are connected to others in our community.

We are committed to working with our staff and unions on these and other issues, to continue to support our people and to develop a diverse and inclusive culture at King's.

As part of this commitment to equality, diversity and inclusion and through this appointment process, it is our aim to develop candidate pools that include applicants from all backgrounds and communities.

We ask all candidates to submit a copy of their CV, and a supporting statement, detailing how they meet the essential criteria listed in the advert. If we receive strong applications from many candidates, we may use the desirable criteria to choose our final shortlist, so please include your evidence against these where possible.

To find out how our managers will review your application, please take a look at our ‘How we Recruit’ pages.