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Clinical Trials Coordinator (XN05)

Employer
Leeds Teaching Hospitals NHS Trust
Location
Leeds
Salary
£28,407 to £34,581 a year
Closing date
3 May 2024

View more

Profession
Other Health Profession
Grade
Band 5
Hours
Full Time
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.

Main duties of the job

The post holder will be responsible for the supervision of support staff i.e. 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.

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.

Our ambition is to:

Be the best Trust to deliver high-quality Clinical Research

Be the Best NHS Trust to Champion Research

And to maintain and grow 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.

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 i.e. 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.

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
  • Strong interpersonal skills, motivated, friendly personality
  • Effective organisational skills and able to prioritise and manage time effectively
  • Proactive and flexible approach, able to work Commitment to personal development
  • Evidence of working in an organisation which includes interaction with multiple departments or organisations
  • Excellent presentation skills
  • Knowledge of data protection issues


Desirable

  • Experience in negotiating clinical trials costs
  • Experience of NHS working with the MDT
  • Experience of study design including protocols and designing case report forms


Qualifications

Essential

  • Educated to degree level or equivalent, or be able to demonstrate relevant experience commensurate with this post.


Desirable

  • Clinical research qualification


Other Criteria

Essential

  • Working knowledge of and experience in the effective use of Microsoft Office software including Excel and PowerPoint
  • Effective communication skills, able to communicate at all levels and ability to provide and receive complex information in relation to study design
  • Ability to pay attention to detail
  • Flexibility to work across different sites if required
  • A willingness to undergo personal development and learn new skills
  • Good Clinical Practice (GCP) training
  • Able to fulfil Occupational Health requirements for the post (with reasonable adjustments if necessary), including clearance on blood borne viruses in compliance with Trust Policy


Experience

Essential

  • Experience within a clinical trials setting.
  • Experience of data and project management
  • Experience of clinical trials co-ordination


Desirable

  • Experience of staff supervision
  • Experience of monitoring clinical trials


Employer details

Employer name

Leeds Teaching Hospitals

Address

Seacroft Hospital

York Road

Leeds

LS14 6UH

Any attachments will be accessible after you click to apply.

C9298-DRI-0142

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