About this role
Job summary
We are seeking a Clinical Trials Monitor to join the Cambridge Clinical Trials Unit (CCTU) Regulatory Team.
The Clinical Trials Monitor will have responsibility for the essential monitoring of non- commercial clinical trials sponsored by Cambridge University Hospitals NHS Foundation Trust to ensure compliance in accordance with Good Clinical Practice (GCP) Guidelines, and all applicable Clinical Trials Regulations.
You will work with colleagues in the CCTU and the R&D office to support monitoring provision of Trust Sponsored Clinical Trials, and support for clinical researchers, under the guidance of a Senior Clinical Trial Monitor.
You will also ensure that the rights of patients involved in research are protected in accordance with the Data Protection Act, Human Rights legislation and GCP.
You will be required to travel and stay overnight for on-site monitoring visits in line with the requirements of the trials.
Main duties of the job
Responsible for monitoring the conduct, documentation and progress of each clinical trial by performing source data verification (SDV) and ensuring that essential site file documents and pharmacy records are up to date in accordance with the requirements of GCP.
Complete written monitoring visit reports on the progress, management and conduct of clinical trial undertaken at the Trust.
Analyse any potential problems and make recommendations to rectify these under the guidance of the Senior Clinical Trial Monitor.Perform external on-site monitoring visits as deemed necessary by the trial risk assessment under the guidance of the Senior Clinical Trial Monitor.
Participate in the development and management of systems including Standard Operating Procedures and R&D Policies and Procedures for CTIMPs sponsored by the Trust.
Maintain up to date knowledge of clinical trial regulations and developments regarding clinical trials monitoring.
About us
Our Trust
Cambridge University Hospitals (CUH) NHS Foundation Trust comprises Addenbrooke's Hospital and the Rosie Hospital in Cambridge. With over 13,000 staff and over 1100 beds the priorities of the Trust focus on a quality service which is all about people - patients, staff and partners. Recognised as providing 'outstanding' care to our patients and rated 'Good' overall by the Care Quality Commissioner, is testament to the skill and dedication of the people who work here. CUH's values - Together - Safe, Kind, Excellent - are at the heart of patient care, defining the way all staff work and behave. The Trust provides accessible high-quality healthcare for the local people of Cambridge, together with specialist services, dealing with rare or complex conditions for a regional, national and international population.
CUH is committed to promoting a diverse and inclusive community - a place where we can all be ourselves. We value our differences and fully advocate and support an inclusive working environment where every individual can fulfil their potential. We want to ensure our people are truly representative of all the communities that we serve. We welcome applications for all positions in the organisation irrespective of people's age, disability, ethnicity, race, nationality, gender identity, sex, sexual orientation, religion or belief, marriage and civil partnership status, or pregnancy and maternity status or social economic background.
Job description Job responsibilities
Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities.
Due to Home Office immigration rules, a full time permanent vacancy cannot be filled by individuals on a Student visa. Therefore, please be advised that if you are a Student visa holder, we will not be able to offer you a full time permanent contract unless you have:
- applied for a Graduate visa
- or you will have successfully completed your course and have applied for a Graduate visa before the anticipated start date of your employment
- or the Trust has agreed that they will Sponsor you as a Skilled Worker and you will complete your studies within 3 months of the anticipated start date of employment
Please note:- Internal applicants on permanent contracts can apply for this post as a secondment or fixed term contract. For secondments, you must have the approval of your line manager before applying. If you are an internal applicant currently on a fixed term contract, you are able to apply for this as a fixed term position.
This vacancy will close at midnight on 25th May 2026
Interviews are due to be held on 2nd June 2026
Benefits to you
At Cambridge University Hospitals, we want to do all we can to support good working days. We offer development opportunities and a wide range of benefits, including on-site leisure facilities, shopping concourse and day nurseries. Our good work programme currently includes providing reduced cost Stagecoach bus travel to and from Cambridge University Hospital site. Park and Ride bus journeys between Babraham Road and Trumpington sites are free, as is the route to and from Cambridge train station and our hospitals. We also subsidise the cost of parking on site for eligible staff.
On CUH campus, hot food is available 24/7 and at a reduced cost for colleagues. Recently we launched the first of our staff pod break spaces. Located in the Deakin Centre, we have a purpose-created colleague-only caf, with free tea and coffee, a break space and private outside area for colleagues to rest, refuel and recharge. Just one of the ways we are working hard to support good working days at CUH.
CUH is committed to assisting employees in achieving a good work-life balance irrespective of role or personal circumstances. Flexible arrangements may include, but are not limited to, part-time working, job-share, term-time working and flexible start and finish times.
Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases, alternative working hours will be considered.
We welcome applications from the Armed Forces.
Person Specification
Qualifications Essential
Science Degree or equivalent experience Evidence of current ICH-GCP training
Desirable
Monitoring Training Evidence of GCLP training
Experience Essential
Minimum of 18 months trial management or monitoring experience of multi-centre CTIMPs within the UK in an NHS Trust, University or pharmaceutical company Experience of applying for regulatory/research approvals or handling research applications within the UK
Desirable
Direct experience of monitoring CTIMPs including laboratories and vendors Experience of central data monitoring processes and outputs Experience of remote monitoring activities & document review
Knowledge Essential
A sound working knowledge of GCP, and UK regulations on clinical trials Knowledge of CTIMP monitoring processes and requirements Knowledge of CTIMP Risk Assessment processes and considerations
Desirable
Demonstrate an understanding of the NHS research environment Proven knowledge of Ethics, HRA, MHRA and R&D approval processes Laboratory oversight and sample handling knowledge, particularly GCP for Labs Knowledge of pharmacovigilance requirements for CTIMPs
Skills Essential
Ability to write and work to Standard Operating Procedures Good IT skills (including the use of databases, Word, Excel, email and the Internet) Excellent communication skills with proven ability to work effectively as part of a team Ability to work independently with minimal day to day supervision, make decisions and delegate work appropriately Time management skills and the ability to prioritise workload and work under pressure Good writing and presentation skills
Desirable
Ability to communicate with senior research staff and communicate sometimes difficult information
Additional Requirements Essential
The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of Together- safe, kind, excellent Able to travel and stay overnight periodically (no more than 3 times a month) in line with the job requirements
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.
Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Employer details Employer name Cambridge University Hospital NHS Foundation Trust
Address Addenbrookes Hospital-Division R&D
CCTU, Clifford Allbutt Building, Bay 13, Room 200
Cambridge
CB2 0QQ
United Kingdom
Employer's website https://www.cuh.nhs.uk (Opens in a new tab)