Clinical Trials Co-ordinator

Job summary

The Haematology Research Speciality offers a busy and dynamic environment, supporting the delivery of a large portfolio of Phase I - III Clinical Trials. We are looking for a passionate and motivated individual to join us in the exciting role of Clinical Trials Coordinator at St Jamess Hospital, Leeds. We can truly make a difference to an individuals care and experience within Leeds Teaching Hospitals Trust (LTHT) and we strive to ensure research is considered as a treatment option for all eligible patients.

For the right candidate this post offers the opportunity to acquire new knowledge and experience in the world of Clinical Trials, in the Research and Innovation Department. The work is varied, interesting, and at times, challenging. You will be supported by a large and experienced team and you will derive satisfaction from a contribution that makes real differences to patients lives as well as the development of new treatments

The team maintains a close working relationship with the Leeds Clinical Research Facility (LCRF), and the post holder will be involved in supporting a cross section of early phase clinical trials conducted in the LCRF.

Expected Shortlisting Date : 9 August 2024

Planned Interview Date : 16 August 2024

Main duties of the job

The successful candidate will be experienced in working within Clinical Trials and will help support the delivery of a high-quality service and ensure the team work collaboratively and maintain the large portfolio of complex studies running within the department.

The Trial Coordinator will be responsible for assisting in Staff Management, Trial Set up, Quality Assurance, Training and Development. They will be the initial contact for all administrative staff within the team and also work closely with the Research Nurses, Principle Investigators and Sponsors.

About us

Research is at the heart of our Trust. Leeds Teaching Hospitals is involved in research at all levels, developing and trialling new treatments for patients. We believe that being involved in cutting-edge research helps us provide better care to our patients.

Over the next 5 years, we aim to be the best Trust to deliver high-quality clinical research and to champion research amongst our staff. We also aim to support and grow our world-class clinical infrastructure and assets for research and innovation.

We have a very proactive Research Academy. It offers an extensive programme of education and training tailored to meet the needs of individuals, teams involved in clinical research delivery in Health and Social Care.

Our five Trust values are part of what make us different. They have been developed by our staff. They are:

- Patient-centred

- Collaborative

- Fair

- Accountable

- Empowered

Leeds Teaching Hospitals is committed to our process of redeploying 'at risk' members of our existing workforce to new roles. As such, all our job adverts are subject to this policy and we reserve the right to close, delay or remove adverts while this process is completed. If you do experience a delay in the shortlisting stage of the recruitment cycle, please bear with us while this process is completed, and contact the named contact if you have any questions.

Job description

Job responsibilities

JOB PURPOSE

The post holder will take responsibility for the overall set up, coordination and data management of clinical trials supporting and facilitating both academic and commercial clinical trials alongside a lead research nurse. The set up process and Quality Assurance are key aspects of this post. They will serve as the main contact point for all internal and external parties involved in set up, maintenance and close down of all clinical trials within their portfolio. They will be responsible for coordination of clinical trials, for the team, and also have a role in recruiting patients into clinical trials ensuring that all trial protocols are adhered to.

The post holder will be familiar with ICH/GCP, and have good all round clinical trial management skills. Excellent IT skills with a working knowledge of Microsoft Office software are essential. You should be enthusiastic, and possess excellent communication, negotiation and organisational skills. Working autonomously, using your own initiative as well as possessing strong team working skills and an ability to motivate staff is essential.

JOB DIMENSIONS

The post holder will be responsible for the supervision of support staff clinical trials assistants and administrative staff, and will work under the direction of the research nurses within the team. Clinical Trials support is provided to a number of Chief and Principle Investigators. They will be working within a busy and expanding clinical trials department where the trials portfolio includes national and specialist group studies plus studies from the commercial sector. The post-holder will be expected to show evidence of considerable experience of working in a research environment.

The number of patients in a trial can range from one to 50+ and the Co-ordinator will be expected to support the Senior Research Nurse/Midwife/Allied Health Practitioner (AHP) ensuring that the team meet all reporting and outcome deadlines. They will undertake regular auditing/monitoring to ensure that research complies with the UK Policy Framework for Health and Social Care Research.

The post holder will be required to work alongside academic and industry partners, the National Institute for Health Research (NIHR) Clinical Research Network (CRN) Yorkshire and Humber (Y&H) and colleagues in neighbouring establishments, attending regional and national meetings as required.

KNOWLEDGE, SKILLS AND EXPERIENCE REQUIRED

The post-holder will be educated to degree level or equivalent, or be able to demonstrate relevant experience commensurate with this post. They would be expected to have experience of working in an organisation which includes interaction with multiple departments or organisations. The post holder will be expected to show a thorough understanding of all legal requirements related to trials and must be familiar with GCP/ICH guidelines and the Declaration of Helsinki. The post requires evidence of relevant experience of Clinical Trials co-ordination and data management skills. Excellent communication skills and the ability to provide and receive complex information in relation to study design are essential for this role. Excellent organisational, negotiation and presentation skills are essential, as well as the ability to work on their own initiative and as a team player.

CORE BEHAVIOURS AND SKILLS

Professional attitude to work, diplomatic and calm under pressure

Ability to work as a team in a busy working environment

Excellent communication skills, able to communicate at all levels

Strong interpersonal skills

Effective organisational skills

Ability to prioritise and manage time effectively

Ability to work autonomously and own initiative

Proactive and flexible approach

Motivated, friendly personality

Commitment to personal development

Coach and develop staff

Ability to motivate staff

CORE KNOWLEDGE AND UNDERSTANDING

The post-holder will be expected to demonstrate complete understanding of Clinical Trial legal requirements and management.

The post-holder will be expected to have knowledge of the complete trials process

Experience of staff supervision would be desirable.

Whilst a knowledge of Clinical Trials is essential, knowledge of the NHS and clinical area is desirable and would be an advantage

Person Specification

Skills & behaviours

Essential

Professional attitude to work, diplomatic and calm under pressure Ability to work as a team in a busy working environment or autonomously and use own initiative Participate in and contribute to team discussions Able to work on own initiative/Proactive approach Able to prioritise and manage time effectively Able to motivate staff Ability to support and educate colleagues, patients and carers Must be able to deal with the public and staff in a pleasant and polite manner at all times. Familiarity with Word Office software packages Standard keyboard skills Good standard of written and spoken English Ability to pay attention to detail

Other Criteria

Essential

Good health/reliable attendance Smart appearance

Qualifications

Essential

Good standard of education to a minimum of GCSE level

Experience

Essential

Administrative experience Able to work unsupervised Familiar with the process of clinical trials

Desirable

Knowledge of research methodologies Clinical Trials experience Experience of contact with patients in either a clinical or research setting

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