The Kings Health Partners Clinical Trials Office (KHP-CTO) is a joint initiative between the member institutions of King’s Health Partners. It has been set up to provide a single interface for those wishing to conduct clinical trials within the partner institutions, and to ensure that there are common, efficient processes for the set up and administration of clinical trials.   http://www.khpcto.co.uk

The KHP-CTO Quality Team was established in 2008 to manage the Sponsor responsibilities for Clinical Trials of Investigational Medicinal Products (CTIMPs), as defined in the Medicines for Human Use (Clinical Trials) Regulations, for trials sponsored or co-sponsored by King’s Health Partner Organisations. Also to assist Chief Investigators with the set up and initiation of their trials and to ensure that these trials are established and conducted according to Good Clinical Practice (GCP) and the Regulations

The post holder will be required to:

• Lead a team of Clinical Research Associates/Administrators to ensure GCP compliance (through monitoring) and manage the sponsor responsibilities of non-commercial trials on behalf of the Partner Organisations who are acting as sponsor or co-sponsor to ensure compliance with the Medicines for Human Use (Clinical Trials) Regulations 2004 (and as amended).
• Set up and monitor clinical trials on behalf of the sponsor where one or more of the partner institutions is acting as sponsor, to ensure regulatory compliance.
• Provide support to investigators conducting clinical trials sponsored by King’s Health Partners Organisations to ensure they are working to the highest quality standards and to monitor and report on the progress of trials across the partner institutions where one or more of the partners is acting as sponsor or co-sponsor
• The post holder will ensure that investigators and their teams run trials according to sponsor’s SOPs, prevailing regulations and best research practice by providing advice, practical assistance and carrying out monitoring functions as appropriate.

This post will be offered on an fixed term for until end of October 2023.

This is a full-time  post - 100% full time equivalent

Key responsibilities

• Assist the Quality Manager (QM) and R&D staff in the partner institutions to ensure that all trials sponsored or co-sponsored by the partner organisations are conducted in accordance with the current UK and EU Clinical Trial legislations and the KHP-CTO SOPs.
• Provide day to day line management of a team of Clinical Research Associates (CRAs) and Clinical Trial Administrators (CTAs). Activities to include: -
• Reviewing and approving Monitoring Visit Reports
• Advise and assist CRAs, conducting co-monitoring visits as required.
• In discussion with the QM, allocating trials to team members and assessing workload of individuals within the team.
• Assisting KHP-CTO Director and QM with staff recruitment as necessary.
• Set and monitor objectives and foster junior staff development.
• Conduct staff appraisals in line with KCL Policy.
• Ensure that development safety update reports, pharmacovigilance reports and protocol amendments are submitted to the MHRA thereby maintaining Clinical Trials Authorisations.
• Set up, initiate and monitor clinical trials on behalf of the sponsor where one or more of the partner institutions is acting as sponsor. Monitoring to be conducted according to Monitoring Plans agreed by the Sponsor institution and the Quality Manager.
• Assist the Quality Manager in the conduct of Regulatory Inspections and sponsor audits for both commercially sponsored and non-commercially sponsored trials on behalf of the partner institutions.
• Maintain a working knowledge of prevailing regulations, guidance, best practices and clinical QA standards regarding the conduct of clinical trials.
• Ensure confidentiality of commercially sensitive information and to ensure data protection imperatives are respected.
• Act as an ambassador for the KHP-CTO.
• Work with other Senior CRAs, CRAs and other staff within KHP-CTO to promote a quality environment and ensure that all trials are conducted in compliance with the regulations and GCP.
• Contribute to the day to day management of the KHP-CTO.
• Liaise closely with the Partner Trusts’ R&D Departments and Research Management & Innovation Directorate staff within KCL, to ensure compliance with the NHS Research Governance Framework, College policies and contractual obligations for clinical trials are met.
• Assist in the prevention, detection and management of clinical research fraud, malpractice and misconduct.
• Provide advice on GCP and related matters to those wishing to conduct clinical trials across the partner institutions.
• Using a problem solving approach whenever possible.
• Assisting the QM in development and implementation of SOPs as required.
• Development of trial risk assessments and trial monitoring plans
• Assist trial Investigators with the development and review of clinical trial protocols to ensure quality regulatory compliance.
• Prepare and submit Clinical Trials Authorisation Applications to the MHRA.
• Assisting the Director and QM in collation of metrics and trial data.
• Lead and work flexibly as a member of a team.
• Assist the Clinical Trials Training Executive(s) in the education and training of trials active staff.  This training to include GCP guidelines, relevant legislation and the research governance framework and to be delivered to staff conducting commercial and non-commercial trials.
• Support Investigators and their teams to conduct clinical trials in line with UK   Regulations.

The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.

Essential criteria

1. Educated to degree level preferably in a related subject area, e.g. a life science or clinical subject.
2. In depth, extensive knowledge of the regulatory requirements for clinical trials and GCP.
3. Strong interpersonal, communication, influential and problem solving skills including the ability to build successful relationships and collaborate in a cross-functional team and maintain a positive work environment
4. Ability to develop, implement and work to SOPs
5. Excellent written and verbal communications skills
6. Proven leadership skills and experience of mentoring, managing, or facilitating others
7. Excellent organisational and time management skills
8. Suitable experience as a Clinical Research Associate gained in the pharmaceutical industry and/or NHS/Academic environments
9. Willingness to travel on occasion including overnight stays
10. Excellent interpersonal skills – tactful and being able to deal with a wide range of people in an enthusiastic and helpful manner whilst being capable of firmly maintaining policies and regulations

Desirable criteria

1. Good presentational, organisational, and administrative skills
2. Experience of a Regulatory Inspection
3. Line management experience
4. Experience and knowledge of working within the NHS Research Governance Framework
5. Experience of setting up and monitoring clinical trials within the NHS/Academic Sector