Clinical Trials Coordinator

Salary: £36,636 to £38,784 with progression to £46,049 per annum

Newcastle University is a great place to work, with excellent benefits. We have a generous holiday package; plus the opportunity to buy more, great pension schemes and a number of health and wellbeing initiatives to support you.

Closing Date: 24 June 2026

The Role

We have an exciting opportunity for an experienced clinical trial coordinator to help deliver pioneering clinical trials with the potential to change the future for people with rare neuromuscular diseases.

You will join a globally recognised team leading translational research and early-phase clinical trials in neuromuscular disease at the John Walton Muscular Dystrophy Research Centre. Our work directly connects scientific discovery with patient care, giving you the opportunity to see the real-world impact of your contribution.

You’ll coordinate a diverse and expanding portfolio of studies, from natural history research through to complex gene therapy trials, working closely with clinicians, researchers, industry partners and international collaborators.

This role supports major national infrastructures, including the Duchenne Hub, coordinated by the JWMDRC, and contributes to the Northern Alliance Advanced Therapy Treatment Centre (NA-ATTC). You will contribute to the Clinical Trial Coordinator (CTC) networks that are sharing expertise, harmonising national costing processes and accelerating access to potential therapies across the UK.

We are committed to your development. You’ll benefit from training opportunities, exposure to complex and innovative trials, and the chance to build networks across national and international research communities.

Based in central Newcastle, you’ll work in a collaborative and supportive environment, with flexible and blended working options available.

This is a full time, fixed term post available until 31 July 2028.

For informal enquiries please email sonia.segovia@newcastle.ac.uk. 

Key Accountabilities

• Early stage engagement with national and international sponsors and academic collaborators on study design, logistics and regulatory requirements
• Prepare and track submissions for Ethical, Health Research Authority and other relevant approvals including Site Specific Assessments, University/NHS Trust Research permissions and NIHR portfolio adoption for a wide range of clinical studies, including observational studies, interventional trials and gene therapy trials. 
• Understanding NHS and University costing processes in order to coordinate complex costings for clinical trials and grant applications (and subsequent amendments), facilitating negotiations with funder representatives and ensuring that adequate funding is agreed
• Taking responsibility for areas of process improvement according to the needs of the JWMDRC and contribute to the wider multi-disciplinary networks facilitating set up, delivery and participant safety oversight for a wide range of clinical studies, including observational, interventional trials and gene therapy trials.  
• Use of advanced communication skills over the life cycle of a study.  Working with numerous internal and external stakeholders (nationally and internationally) simultaneously to ensure that:
  • Sponsor and academic collaborators are aware of local and national costing and regulatory requirements
  • Studies are opened in a timely manner
  • Recruitment targets are met
  • Relevant parties are aware of study progress
  • Clinical trial regulations are followed

• Preparation, submission and dissemination of study amendments, ensuring that changes are implemented in a timely and accurate manner
• Management of study systems and documentation in accordance with Good Clinical Practice (GCP) including master files, site files, databases, version control and document tracking
• Preparation for, facilitation of and action planning following audits and/or inspections from internal and external parties ensuring that study documentation is presented in accordance with GCP
• Take responsibility for continuous improvement of research administrative processes and target achievement, in line with changing regulations and faculty strategy
• Contribute to sharing of best practice with the local and national clinical trial coordinator networks
• Develop SOPs, communication plans, guidance and protocols for the set-up, delivery and communication of clinical trials internally and support the work around it within the relevant networks that JWMDRC is part of
• Take responsibility for identifying own learning needs and that of the research team, including identifying appropriate courses to ensure up to date knowledge in the regulations governing clinical research and research data
• Undertake other reasonable duties or responsibilities as requested

The Person

Knowledge, Skills and Experience

• Previous experience in a relevant role
• Knowledge of clinical research regulatory requirements in the UK
• Knowledge of local and national research governance and management processes
• National and international clinical trial experience
• Experience of working to standards of Good Clinical Practice
• An understanding of ethical issues surrounding research and patients
• Knowledge of NIHR processes, including Portfolio adoption and expressions of interest/feasibility
• Experience of assisting clinical trial recruitment, including recording and tracking of recruitment using LPMS and CPMS
• Experience of preparing and presenting information for presentation and dissemination at meetings and/or scientific conferences
• A demonstrable understanding of requirements for the setup of natural history studies, standard CTIMP trials and gene therapy trials

Attributes and Behaviour

• Advanced oral and written communication skills
• Ability to effectively prioritise workload, to use initiative and work under pressure, working independently as appropriate, but being aware when to refer decisions upwards or ask for further advice
• Excellent attention to detail
• Excellent Communicator
• High level of organisation
• Occasional work outside core working hours will be required
• National and occasional international travel will be required
• Proven track record in working as part of a multi-disciplinary team

Qualifications

• 1st degree in relevant subject or relevant experience working in clinical research
• Formal training in GCP

Newcastle University is a global University where everyone is treated with dignity and respect.  As a University of Sanctuary, we aim to provide a welcoming place of safety for all, offering opportunities to people fleeing violence and persecution.

We are committed to being a fully inclusive university which actively recruits, supports and retains colleagues from all sectors of society.  We value diversity as well as celebrate, support and thrive on the contributions of all of our employees and the communities they represent.  We are proud to be an equal opportunities employer and encourage applications from individuals who can complement our existing teams, we believe that success is built on having teams whose backgrounds and experiences reflect the diversity of our university and student population.

At Newcastle University we hold a Gold Athena Swan award in recognition of our good employment practices for the advancement of gender equality.  We also hold a Race Equality Charter Bronze award in recognition of our work towards tackling race inequality in higher education REC.  We are a Disability Confident employer and will offer an interview to disabled applicants who meet the essential criteria for the role as part of the offer and interview scheme.

In addition, we are a member of the Euraxess initiative supporting researchers in Europe. 

Requisition ID: 29468