Clinical Trials Co-ordinator (XN05)

Leeds Teaching Hospitals; Leeds; On-site; GBP 30,000 - 40,000; Full time

Job summary

A prominent healthcare institution in Leeds is seeking a proactive Clinical Trials Coordinator to oversee oncology clinical trials. This permanent, full-time position involves coordinating study setups, ensuring compliance with protocols, and managing communication with sponsors. Ideal applicants will have a degree and clinical research qualification, along with strong organizational and communication skills. This role supports critical research initiatives and offers the opportunity to contribute significantly to patient care through innovative clinical trials.

Qualifications

• Educated to degree level or equivalent, or relevant experience.
• Clinical research qualification.
• Effective organizational skills and able to prioritize.

Responsibilities

• Coordinate study feasibility and manage communication between sponsors and sites.
• Track ethics and regulatory submissions, ensuring approvals.
• Liaise among sponsors, investigators, and vendors for trial readiness.

Skills

Clinical trial management

Effective communication

Organizational skills

Microsoft Office proficiency

Interpersonal skills

Education

Degree or equivalent experience

Clinical research qualification

Job description

TheOncology Set Up Research Team is recruiting!

TheResearch and Innovation Department is continuing its exciting expansion. Wehave several research specialities and the Oncology research portfolio islooking 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.

Thepost holder will contribute actively to the conduct and coordination of theset up of Clinical Trials in the Oncology Research Portfolio. The main tasksare: Liaise with Sponsors at the point of set up of Clinical Trials. Liaisewith PI's & Nursing team during the set up phase and coordinate set up totrial opening across all Oncology Specialities. In addition of beingresponsible for ensuring that the Set up of Clinical Trials are timely and tovery high standards. Compliance with Trust policy, study protocolrequirements, local and national guidance and legislation is required

Ifyou are interested in the post, we would like to encourage you to contact therecruiting manager for an informal discussion.

Main duties of the job

Weare looking to recruit a proactive and self-motivated individual with a keeninterest in research to work within Oncology Set up team.

Thepost-holder will be responsible for:

Keyduties include coordinating study feasibility by distributing and collectingquestionnaires and managing communication between sponsors and sites.

Therole covers preparation, collection, and tracking of essential regulatorydocuments, maintaining data in EDGE, completing the One Form, and serving asthe main contact for queries.

Responsibilitiesalso include tracking ethics and regulatory submissions, ensuring approvalsare in place before activation, and monitoring contract and budget progress.

Thepost-holder will coordinate study binders, shipments of IP, lab kits, andsupplies, and support site onboarding for systems such as IWRS, EDC, andtraining portals.

Theywill act as liaison among sponsors, investigators, coordinators, and vendors,providing clear updates on readiness and regulatory progress. Additionaltasks include ensuring GCP/ICH compliance, confirming all activationrequirements, scheduling SIVs, maintaining trackers, reporting progress, andensuring a clean handover to the study team.

About us

Researchis at the heart of our Trust. Leeds Teaching Hospitals is involved inresearch at all levels, developing and trialling new treatments for patients.We believe that being involved in cutting-edge research helps us providebetter care to our patients.

Overthe next 5 years, we aim to be the best Trust to deliver high-qualityclinical research and to champion research amongst our staff. We also aim tosupport and grow our world-class clinical infrastructure and assets forresearch and innovation.

Wehave a very proactive Research Academy. It offers an extensive programme ofeducation and training tailored to meet the needs of individuals, teamsinvolved in clinical research delivery in Health and Social Care.

Ourfive Trust values are part of what make us different. They have beendeveloped by our staff. They are:

-Accountable

-Empowered

LeedsTeaching Hospitals is committed to our process of redeploying 'at risk'members of our existing workforce to new roles. As such, all our job advertsare subject to this policy and we reserve the right to close, delay or removeadverts while this process is completed. If you do experience a delay in theshortlisting stage of the recruitment cycle, please bear with us while thisprocess is completed, and contact the named contact if you have anyquestions.

Job responsibilities

Thepost holder will take responsibility for the overall set up, coordination and

datamanagement of clinical trials supporting and facilitating both academic and

commercialclinical trials alongside a lead research nurse. The set up process

andQuality Assurance are key aspects of this post. They will serve as the main

contactpoint for all internal and external parties involved in set up, maintenance

andclose down of all clinical trials within their portfolio. They will beresponsible

forcoordination of clinical trials, for the team, and also have a role inrecruiting

patientsinto clinical trials ensuring that all trial protocols are adhered to.

Thepost holder will be familiar with ICH/GCP, and have good all round clinical

trialmanagement skills. Excellent IT skills with a working knowledge of Microsoft

Officesoftware are essential. You should be enthusiastic, and possess excellent

communication,negotiation and organisational skills. Working autonomously,

usingyour own initiative as well as possessing strong team working skills and an

abilityto 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

Skills & Behaviours

• Flexibility to work across different sites if required
• Able to fulfil Occupational Health requirements for the post (with reasonable adjustments if necessary),

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.