Salary: £30,805 to £31,637 with progression to £34,132 per annum (pro rata)
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: 25 July 2025
The Role
We have an exciting opportunity for a Clinical Trials Administrator to join our successful UKCRC registered Clinical Trials Unit.
You will work within a multi-disciplinary team including Trial and Data Managers to ensure that clinical trials are managed in line with sponsor, regulatory and research governance requirements. This is an exceptional opportunity for the right individuals to join our team.
You should be an enthusiastic and motivated individual with strong administration, communication and organisational skills, as well as excellent attention to detail. A working knowledge of Good Clinical Practice and experience of project planning and management are desirable for this post.
This post is full time, fixed term until 31.08.26
Part time working would be considered.
To apply for the position, we will need your CV and a cover letter outlining how you are suitable for the role using evidence to highlight how you meet the essential criteria in the knowledge, skills and experience as listed in the job description.
Enquiries about this post can be made through:
Miss Chrissie Butcher (Senior Trial Manager) [email protected]
Further details about NCTU can be found via the following link: https://www.ncl.ac.uk/nctu/trials/
Key Accountabilities
• Assist with the set-up of studies managed through NCTU, including assisting the Trial Manager with the production and collation of documentation required for compliance with legislative frameworks and applications for Clinical Trials Authorisation, Ethical Opinion and R&D approval as well as sending out all documents required by sites to complete the set-up process, collating all returned core documents and checking for completeness. Set-up site initiation calls and prepare the site file for site activation sign off
• Support the participating study sites, maintaining regular contact with site personnel to check on trial progress and trial supplies. Send out additional and updated trial supplies and documents. Deal with routine trial queries, passing non-routine queries to the appropriate trial management staff or other trial professionals where appropriate, ensuring that any issues are resolved within a reasonable timeframe. Use initiative to tackle any practical difficulties reported by sites under the guidance of the Senior Trial Manager and Trial Manager
• Work with the Data Manager to maintain systems to track the progress of the trial such as tracking accruals at different sites, liaising with site leads for up to date information and logging this on the trial database; and tracking the return of screening logs, Case Report Forms (CRF) and patient questionnaires, check completed CRF’s and questionnaires, raise queries and rectify errors
• Process Serious Adverse Events (SAE) that are reported, recording the information into the study SAE logs. Enter SAE data into trial databases, track and resolve any queries from Clinical Coordinators, study sites, Sponsor and regulatory authorities where requested. Follow the event up until resolution of the event and queries
• Support the effective administration of trial steering committees, data monitoring committees and internal trial management meetings by preparing timetables and agendas; arrange printing of meeting documents; taking minutes in meetings and chasing resulting actions
• Assist with the close down of studies by setting up close down visits and teleconferences, preparing and tracking close down checklists, tracking Patient Reported Outcomes and preparing the Trial Master file for archiving and arranging the archiving process
• Provide cover for the Trial Manager as required and requested during any absences. On these occasions, the post-holder will monitor trial progress closely, providing weekly reports on progress to the Senior Trial Manager.
• Arrange travel and accommodation for NCTU staff, contractors, visitors and meeting attendees as requested by the Trial Manager. Arrange conference calls as requested
• Plan and organise mailshots and newsletters, contact suppliers for quotes and details of services provided. Assist with the design and organisation of promotional material for NCTU studies. Access the effectiveness of previously used items (calendars, stationery, posters etc.) and develop ideas for new material
• Assist in review of standard operating procedures relating to the Trial Administration role. Train and supervise admin staff involved in supporting trials and data management, on the rules and procedures to be used
• Take responsibility for identifying own learning needs, including participating in regular Performance and Development Review meetings with a Trial Manager or Data Manager to set educational and professional development goals and objectives and chart progress in relation to these
The Person
Knowledge, Skills and Experience
• Experience of working within a clinical and/or research environment
• Critical and intelligent attention to detail and high standards of accuracy
• Significant administrative support experience
• Excellent oral and written communication
• Good working knowledge of MS Office applications
• Ability to liaise closely with colleagues at all levels, both internal and external
Attributes and Behaviour
• Enthusiastic, innovative approach to challenges
• Ability to work to deadlines
• Ability to organise own workload, with minimum supervision and work effectively as part of a team
• Demonstrated commitment to ongoing personal development and training
Qualifications
• A Levels/NVQ Level 3 or equivalent, or significant relevant experience of working in clinical research
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 silver 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: 28262
