Job summary
The
Oncology Set Up Research Team is recruiting!
The
Research and Innovation Department is continuing its exciting expansion. We
have several research specialities and the Oncology research portfolio is
looking for a Band 5 Clinical Trials Coordinator. It is a full time time post
(1.0 WTE), with a permanent contract. This post will be based at SJUH.
The
post holder will contribute actively to the conduct and coordination of the
set up of Clinical Trials in the Oncology Research Portfolio. The main tasks
are: Liaise with Sponsors at the point of set up of Clinical Trials. Liaise
with PI's & Nursing team during the set up phase and coordinate set up to
trial opening across all Oncology Specialities. In addition of being
responsible for ensuring that the Set up of Clinical Trials are timely and to
very high standards. Compliance with Trust policy, study protocol
requirements, local and national guidance and legislation is required
If
you are interested in the post, we would like to encourage you to contact the
recruiting manager for an informal discussion.
Main duties of the job
We
are looking to recruit a proactive and self-motivated individual with a keen
interest in research to work within Oncology Set up team.
The
post-holder will be responsible for:
Key
duties include coordinating study feasibility by distributing and collecting
questionnaires and managing communication between sponsors and sites.
The
role covers preparation, collection, and tracking of essential regulatory
documents, maintaining data in EDGE, completing the One Form, and serving as
the main contact for queries.
Responsibilities
also include tracking ethics and regulatory submissions, ensuring approvals
are in place before activation, and monitoring contract and budget progress.
The
post-holder will coordinate study binders, shipments of IP, lab kits, and
supplies, and support site onboarding for systems such as IWRS, EDC, and
training portals.
They
will act as liaison among sponsors, investigators, coordinators, and vendors,
providing clear updates on readiness and regulatory progress. Additional
tasks include ensuring GCP/ICH compliance, confirming all activation
requirements, scheduling SIVs, maintaining trackers, reporting progress, and
ensuring a clean handover to the study team.
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
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 description
Job responsibilities
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.
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
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
Skills & Behaviours
Essential
- Flexibility to work across different sites if required
- Able to fulfil Occupational Health requirements for the post (with reasonable adjustments if necessary),
Experience
Essential
- Experience within a clinical trials setting
- Experience of data and project management
- Experience of clinical trials co-ordination
- Good Clinical Practice (GCP) training
- A willingness to undergo personal development and learn new skills
Desirable
- Experience of staff supervision
- Experience of monitoring clinical trials
- Knowledge of clinical area
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
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
Skills & Behaviours
Essential
- Flexibility to work across different sites if required
- Able to fulfil Occupational Health requirements for the post (with reasonable adjustments if necessary),
Experience
Essential
- Experience within a clinical trials setting
- Experience of data and project management
- Experience of clinical trials co-ordination
- Good Clinical Practice (GCP) training
- A willingness to undergo personal development and learn new skills
Desirable
- Experience of staff supervision
- Experience of monitoring clinical trials
- Knowledge of clinical area
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.
