Job summary
The
Haematology Clinical Trials Department 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 Senior Clinical Trials Assistant at St Jamess Hospital,
Leeds. We can truly make a difference to an individuals care and experience
within LTHT and we strive to ensure research is considered as a treatment
option for all eligible patients.
The
candidate must have clinical trials experience and be able to demonstrate
experience/ understanding of how clinical trials are run in the NHS. They will
have worked on various EDC systems and be able to work autonomously to answer
all data queries on a number of trials within the portfolio.
Main duties of the job
The
successful candidate 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. They will work closely with
the Admin Team, Research Nurses, Investigators and Sponsors.
The
Senior Clinical Trials Assistant role involves coordinating the Haematology
portfolio, submitting study feasibilities, new trial set up and running the
weekly disease group meetings. They will track all patient activity, SAEs,
deviations and ensure the tracking logs are maintained.
They
will be the initial point of contact for all recruiting trials within their
disease group and track patients throughout their journey in a Clinical
Trial, collecting complex data to enter into case report forms, attention to
detail is essential. They will ensure all trial protocols are adhered to and
work with study monitors to facilitate monitoring visits, answering data
queries, and adhering to Good Clinical Practice.
They
will maintain the study site files, filing essential documents and processing
amendments involving multiple departments within the Trust.
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
For
the right candidate this post offers the opportunity to acquire new knowledge
and experience in the world of Clinical Trials, 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.
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.
Job description
Job responsibilities
For
the right candidate this post offers the opportunity to acquire new knowledge
and experience in the world of Clinical Trials, 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.
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.
Person Specification
Experience
Essential
- Previous administrative experience
- Clinical trials experience
- Experience working in NHS having direct or indirect contact with patients in either a clinical or research setting
- Knowledge of research methodologies
- Understanding of the NHS and the organisation
Desirable
- Previous experience of working within Clinical Trials Management within the NHS
- Informed consent experience
Additional Requirements
Essential
- Able to fulfil Occupational Health requirements for the post (with reasonable adjustments if necessary),
- Willing to undergo training as required
- Good Clinical Practice (GCP) training
Additional Requirements
Essential
- Able to fulfil Occupational Health requirements for the post (with reasonable adjustments if necessary),
- Willing to undergo training as required
- Good Clinical Practice (GCP) training
Qualifications
Essential
- Good standard of education NVQ level 3 or equivalent
Desirable
- AHCS registered
- NHS Care Certificate
Skills & behaviours
Essential
- Good communicator and use of initiative.
- Able to work on own or as part of a team
- Able to work on own initiative/proactive approach
- Honest and fair approach when dealing with work, colleagues and the team
- Must be able to deal with the public and staff in a pleasant and polite manner at all times.
- Excellent IT skills
- Good interpersonal skills
- Effectively communicate with multidisciplinary team members
- Ability to pay attention to detail
- Time management skills
Desirable
- Previous clinical skills training e.g. taking clinical observations, venepuncture, cannulation, ECG
Person Specification
Experience
Essential
- Previous administrative experience
- Clinical trials experience
- Experience working in NHS having direct or indirect contact with patients in either a clinical or research setting
- Knowledge of research methodologies
- Understanding of the NHS and the organisation
Desirable
- Previous experience of working within Clinical Trials Management within the NHS
- Informed consent experience
Additional Requirements
Essential
- Able to fulfil Occupational Health requirements for the post (with reasonable adjustments if necessary),
- Willing to undergo training as required
- Good Clinical Practice (GCP) training
Additional Requirements
Essential
- Able to fulfil Occupational Health requirements for the post (with reasonable adjustments if necessary),
- Willing to undergo training as required
- Good Clinical Practice (GCP) training
Qualifications
Essential
- Good standard of education NVQ level 3 or equivalent
Desirable
- AHCS registered
- NHS Care Certificate
Skills & behaviours
Essential
- Good communicator and use of initiative.
- Able to work on own or as part of a team
- Able to work on own initiative/proactive approach
- Honest and fair approach when dealing with work, colleagues and the team
- Must be able to deal with the public and staff in a pleasant and polite manner at all times.
- Excellent IT skills
- Good interpersonal skills
- Effectively communicate with multidisciplinary team members
- Ability to pay attention to detail
- Time management skills
Desirable
- Previous clinical skills training e.g. taking clinical observations, venepuncture, cannulation, ECG
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.
