Clinical Trials Co-ordinator (XN05) in Leeds

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 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 PIs & Nursing team during the set up phase and coordinate set up to trial opening across all Oncology Specialities.
• Ensure that the set up of Clinical Trials is 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 the Oncology Set up team. The post-holder will be responsible for:

• Coordinating study feasibility by distributing and collecting questionnaires and managing communication between sponsors and sites.
• Preparation, collection, and tracking of essential regulatory documents, maintaining data in EDGE, completing the One Form, and serving as the main contact for queries.
• Tracking ethics and regulatory submissions, ensuring approvals are in place before activation, and monitoring contract and budget progress.
• Coordinating study binders, shipments of IP, lab kits, and supplies, and supporting site onboarding for systems such as IWRS, EDC, and training portals.
• Acting as liaison among sponsors, investigators, coordinators, and vendors, providing clear updates on readiness and regulatory progress.
• 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 and 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:

• 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 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:

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

Skills & behaviours:

• 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.
• Experience in negotiating clinical trials costs.

Experience:

• 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.
• 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.