Job summary
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.
Expected Shortlisting Date:01/08//2024
Planned Interview Date:06/08/2024
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. 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
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
PRINCIPAL
DUTIES & AREAS OF RESPONSIBILITY
Clinical
Trial Portfolio Management
To
be responsible for coordination of clinical trials ensuring that trial
protocols are adhered to. This will include management of the trial
portfolios consisting of commercial and national studies from trial agreement
through to completion of the study. Be accountable for the preparation of
clinical trials for conduct in the department, and Innovation (R&I) and
support service departments in line with local Trust trial including review
of trial protocols, submissions to ethics committees, Research procedures,
trial indemnity arrangements and all regulatory requirements To take the
lead in all other trial administration procedures i.e. ethics and R&I
reports Ensure that all contracts, indemnity agreements and all other trial
related documents are in place prior to commencement of studies. Ensure
regulatory and governance issues are adhered to Ensure recruitment
information is up to date and comprehensive on all relevant clinical trial
databases e.g. EDGE Register and randomise patients into trials.
Extracting clinical data from medical records onto Case Report Forms (CRFs)
in liaison with clinicians, research nurses and medical records staff.
Ensure all protocol amendments/addendums are processed and implemented
accurately To be the main contact point for all trial related activity
within the portfolio and delegate work as appropriate. To work with the
relevant research groups to develop specific clinical trials portfolios
Liaise closely with research nurses regarding day to day trials management.
To regularly review clinical trial activity and assist in analysis of complex
clinical trial information Preparing work sheets that highlight the
necessary data to be captured for particular trial patient visits, for use as
primary source documents when required. Ensure that any queries on the CRFs
are logged and dealt with quickly by the relevant clinician/research nurse.
Ensure that the data recorded on the CRFs of trial participants are entered
onto the computer database completely and accurately in a timely fashion.
Identify any problems with entry of data onto database and work with the
relevant staff to resolve them. To collate and report the data from all
centres participating in the trial on a continuous basis to ensuring that
expected and un-expected adverse events are identified early and the
appropriate decisions are taken regarding trial recruitment. Responsibility
for timely reporting of Serious Adverse Events (SAE) and Suspected Unexpected
Serious Adverse Reactions (SUSARS) to the appropriate trial sponsors or
regulatory authorities, in liaison with the Research Nurses/Midwives/AHPs and
Principal Investigator.
Plan the administrative management of the specific research projects including
the establishment and maintenance of office systems. Compile and maintain a
master set of source documents and trial master/site file for each specific
project.
Responsible for the maintenance of all clinical trials office systems
including log books, databases, protocols, and patient information sheets and
protocol site files.
Coordinate and prepare necessary papers/documents for key meetings and take
minutes at the meeting as required.
Assist in the functioning of the electronic quality management systems
utilised within the department, including document uploads and tracking.
Assist
in the statistical analysis of clinical trial results as appropriate.
Attend trial close down meetings following trial completion and supervise the
preparation of documents archiving of study site files All trial functions
to be undertaken in accordance with GCP, advise on GCP queries from other
centres. Attend regular administration and general team meetings. Attend
all trial related meetings. This may involve national or international
travel. General administrative duties arising from the clinical trials
activity of the unit, as appropriate to this post. Development of Clinical
Research Attend academic meetings re protocol developments To advise clinicians
on the process of obtaining approval for local trials and to support the
submission of applications. To produce clear and well-designed data
collection forms, and specify particular requirements for the project
database. Work with the relevant staff on the design, validation,
production and management of databases and information systems used for the
collection, analysis, and presentation of trials data. Facilitate the
development of audit projects and present findings at designated meetings as
appropriate. Financial Management and Negotiation To negotiate with local
Trust service support departments regarding costing of clinical trials, e.g.
pharmacy, radiology, and pathology, and negotiate set up contracts
Undertake cost comparisons to assess departmental costs. Check eligibility
and organise regular payments of travel expenses to patients on clinical
trials. Checking eligibility of payments to patients. To liaise closely
with the Finance Managers regarding the financial management for each
clinical trial, calculating all payments involved, ensuring invoices are
raised and keeping a log of all payments made. Communication Establish and
maintain effective working relationships with all relevant organisations and
individuals; LTHT R&I, other NIHR research teams, other providers of NHS
services, Clinical Trials Units, and Industry. Liaise with research staff
in other units participating in the clinical trial to ensure accurate
recording and timely submission of data to the centre, as per protocol,
electronically or by other means in real time. To provide feedback to the
relevant research groups on trial recruitment and status and to highlight
areas of excellence and concern. To provide information about existing and
new trials to clinicians, research nurses and data managers. Liaison with
research staff to monitor trial recruitment. Work with the Principal
Investigator for each trial to ensure he/she is constantly up to date for the
trial. Deliver presentations at meetings as appropriate. Answering
telephone queries from trials centres, patients, clinicians and health
professionals regarding specific trials. Staff Management Supervise the day
to day workload of clinical trials assistants including their trials related
data collection and general study administration.
Participate
in own and others appraisals The Leeds Improvement Method: has a
responsibility to improve the quality and safety of our service. It is
expected that in fulfilling a leadership role you will be proactive in
promoting and using the Leeds Improvement Method Quality Assurance
Involvement in the writing and updating of Standard Operating Procedures
(SOPs) amending in line with changing legislation and circumstances.
Undertake regular monitoring visits to ensure that research complies with
research governance guidelines. Actively promote and use the Leeds
Improvement Method to improve the quality and safety of the service.
Professional Development Complete Mandatory and Priority training within
the specified timescales To maintain a high level of knowledge concerning
clinical cancer research in all the areas covered by the network. To
develop and maintain appropriate information technology skills if necessary
by attendance at formal training courses. Health and Safety/Risk Management
All staff are responsible for working with their colleagues to maintain and
improve the quality of services provided to our patients and other service
users. This includes complying at all times with the Leeds Teaching Hospitals
NHS Trust Policies, including Health and Safety policies, in particular by
following agreed safe working procedures, and reporting incidents using the
Trust Incident Reporting system.
Job description
Job responsibilities
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
PRINCIPAL
DUTIES & AREAS OF RESPONSIBILITY
Clinical
Trial Portfolio Management
To
be responsible for coordination of clinical trials ensuring that trial
protocols are adhered to. This will include management of the trial
portfolios consisting of commercial and national studies from trial agreement
through to completion of the study. Be accountable for the preparation of
clinical trials for conduct in the department, and Innovation (R&I) and
support service departments in line with local Trust trial including review
of trial protocols, submissions to ethics committees, Research procedures,
trial indemnity arrangements and all regulatory requirements To take the
lead in all other trial administration procedures i.e. ethics and R&I
reports Ensure that all contracts, indemnity agreements and all other trial
related documents are in place prior to commencement of studies. Ensure
regulatory and governance issues are adhered to Ensure recruitment
information is up to date and comprehensive on all relevant clinical trial
databases e.g. EDGE Register and randomise patients into trials.
Extracting clinical data from medical records onto Case Report Forms (CRFs)
in liaison with clinicians, research nurses and medical records staff.
Ensure all protocol amendments/addendums are processed and implemented
accurately To be the main contact point for all trial related activity
within the portfolio and delegate work as appropriate. To work with the
relevant research groups to develop specific clinical trials portfolios
Liaise closely with research nurses regarding day to day trials management.
To regularly review clinical trial activity and assist in analysis of complex
clinical trial information Preparing work sheets that highlight the
necessary data to be captured for particular trial patient visits, for use as
primary source documents when required. Ensure that any queries on the CRFs
are logged and dealt with quickly by the relevant clinician/research nurse.
Ensure that the data recorded on the CRFs of trial participants are entered
onto the computer database completely and accurately in a timely fashion.
Identify any problems with entry of data onto database and work with the
relevant staff to resolve them. To collate and report the data from all
centres participating in the trial on a continuous basis to ensuring that
expected and un-expected adverse events are identified early and the
appropriate decisions are taken regarding trial recruitment. Responsibility
for timely reporting of Serious Adverse Events (SAE) and Suspected Unexpected
Serious Adverse Reactions (SUSARS) to the appropriate trial sponsors or
regulatory authorities, in liaison with the Research Nurses/Midwives/AHPs and
Principal Investigator.
Plan the administrative management of the specific research projects including
the establishment and maintenance of office systems. Compile and maintain a
master set of source documents and trial master/site file for each specific
project.
Responsible for the maintenance of all clinical trials office systems
including log books, databases, protocols, and patient information sheets and
protocol site files.
Coordinate and prepare necessary papers/documents for key meetings and take
minutes at the meeting as required.
Assist in the functioning of the electronic quality management systems
utilised within the department, including document uploads and tracking.
Assist
in the statistical analysis of clinical trial results as appropriate.
Attend trial close down meetings following trial completion and supervise the
preparation of documents archiving of study site files All trial functions
to be undertaken in accordance with GCP, advise on GCP queries from other
centres. Attend regular administration and general team meetings. Attend
all trial related meetings. This may involve national or international
travel. General administrative duties arising from the clinical trials
activity of the unit, as appropriate to this post. Development of Clinical
Research Attend academic meetings re protocol developments To advise clinicians
on the process of obtaining approval for local trials and to support the
submission of applications. To produce clear and well-designed data
collection forms, and specify particular requirements for the project
database. Work with the relevant staff on the design, validation,
production and management of databases and information systems used for the
collection, analysis, and presentation of trials data. Facilitate the
development of audit projects and present findings at designated meetings as
appropriate. Financial Management and Negotiation To negotiate with local
Trust service support departments regarding costing of clinical trials, e.g.
pharmacy, radiology, and pathology, and negotiate set up contracts
Undertake cost comparisons to assess departmental costs. Check eligibility
and organise regular payments of travel expenses to patients on clinical
trials. Checking eligibility of payments to patients. To liaise closely
with the Finance Managers regarding the financial management for each
clinical trial, calculating all payments involved, ensuring invoices are
raised and keeping a log of all payments made. Communication Establish and
maintain effective working relationships with all relevant organisations and
individuals; LTHT R&I, other NIHR research teams, other providers of NHS
services, Clinical Trials Units, and Industry. Liaise with research staff
in other units participating in the clinical trial to ensure accurate
recording and timely submission of data to the centre, as per protocol,
electronically or by other means in real time. To provide feedback to the
relevant research groups on trial recruitment and status and to highlight
areas of excellence and concern. To provide information about existing and
new trials to clinicians, research nurses and data managers. Liaison with
research staff to monitor trial recruitment. Work with the Principal
Investigator for each trial to ensure he/she is constantly up to date for the
trial. Deliver presentations at meetings as appropriate. Answering
telephone queries from trials centres, patients, clinicians and health
professionals regarding specific trials. Staff Management Supervise the day
to day workload of clinical trials assistants including their trials related
data collection and general study administration.
Participate
in own and others appraisals The Leeds Improvement Method: has a
responsibility to improve the quality and safety of our service. It is
expected that in fulfilling a leadership role you will be proactive in
promoting and using the Leeds Improvement Method Quality Assurance
Involvement in the writing and updating of Standard Operating Procedures
(SOPs) amending in line with changing legislation and circumstances.
Undertake regular monitoring visits to ensure that research complies with
research governance guidelines. Actively promote and use the Leeds
Improvement Method to improve the quality and safety of the service.
Professional Development Complete Mandatory and Priority training within
the specified timescales To maintain a high level of knowledge concerning
clinical cancer research in all the areas covered by the network. To
develop and maintain appropriate information technology skills if necessary
by attendance at formal training courses. Health and Safety/Risk Management
All staff are responsible for working with their colleagues to maintain and
improve the quality of services provided to our patients and other service
users. This includes complying at all times with the Leeds Teaching Hospitals
NHS Trust Policies, including Health and Safety policies, in particular by
following agreed safe working procedures, and reporting incidents using the
Trust Incident Reporting system.
Person Specification
Qualifications
Essential
- Educated to degree level or equivalent, or be able to demonstrate relevant experience commensurate with this post.
Desirable
- Clinical research qualification
Experience
Essential
- Experience within a clinical trials setting
- Experience of data and project management
- Experience of clinical trials co-ordination
- Evidence of working in an organisation which includes interaction with multiple departments or organisations
- Excellent presentation skills
- Knowledge of data protection issues
Desirable
- Experience of staff supervision
- Experience of monitoring clinical trials
- Experience of NHS working with the MDT
- Experience of study design including protocols and designing case report forms
Other criteria
Essential
- Flexibility to work across different sites if required
- Reliable
- Enthusiasm
- 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
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
- 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
Desirable
- Experience in negotiating clinical trials costs
- Experience with Access databases
Person Specification
Qualifications
Essential
- Educated to degree level or equivalent, or be able to demonstrate relevant experience commensurate with this post.
Desirable
- Clinical research qualification
Experience
Essential
- Experience within a clinical trials setting
- Experience of data and project management
- Experience of clinical trials co-ordination
- Evidence of working in an organisation which includes interaction with multiple departments or organisations
- Excellent presentation skills
- Knowledge of data protection issues
Desirable
- Experience of staff supervision
- Experience of monitoring clinical trials
- Experience of NHS working with the MDT
- Experience of study design including protocols and designing case report forms
Other criteria
Essential
- Flexibility to work across different sites if required
- Reliable
- Enthusiasm
- 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
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
- 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
Desirable
- Experience in negotiating clinical trials costs
- Experience with Access databases
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.
