Job summary
Be solely responsible for a portfolio of clinical trials, managing individual trial set up processes, from initiation to completion, in a timely and efficient manner.
Be an integral part of the clinical trials team, ensuring trials are opened to a robust timeframe enabling novel treatments to be available to patients.
Main duties of the job
To operate autonomously to process applications to all relevant bodies to obtain regulatory and ethical approvals for clinical research protocols, including those which have been developed locally ( includes MHRA, NRES, Trust R&D)
- Liaise with study clinicians and research nurses to ensure compliance with local SOP's and to ensure new research protocols are produced and submitted as planned by PI
- Taking responsibility for a portfolio of trials ensuring processes are followed and tracked and checked, to ensure compliance with regulatory requirements
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.
Please note: Internal applicants on permanent contracts can only apply for this post as a secondment and must have the approval of your current line manager before applying.
This vacancy will close on the 29th June 2025.
Interviews are due to be held on the 8th July 2025.
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.
Job description
Job responsibilities
Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities.
Please note: Internal applicants on permanent contracts can only apply for this post as a secondment and must have the approval of your current line manager before applying.
This vacancy will close on the 29th June 2025.
Interviews are due to be held on the 8th July 2025.
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
- Educated to degree level or equivalent in relevant subject Service/ Business Admin /ITQ or equivalent
Desirable
- Evidence of continuing professional development in administration processes / data management
Experience
Essential
- In depth current knowledge and experience of the setting up process of cancer clinical trials
- Experience of data collection within a scientific or medical environment
- Experience of using clinical trials database.
- Prioritising, planning and organising own tasks
- Experience of working autonomously within guidelines and to tight deadlines
- Experience of using own initiative and working independently
- Experience of working across the MDT
- Experience of liaising with external agencies
Desirable
- Experience of audit.
- Participation in site initiation visits
- Training other members of staff
Knowledge
Essential
- Sound understanding of ethical and quality standards applicable to clinical trials, including EU directive, ICH GCP
- GCP trained
- Excellent working knowledge of Microsoft Office packages
- Understanding of confidentiality and data protection
Desirable
- Interrogation of data base to produce relevant reports
Skills
Essential
- Ability to work in a team.
- Good communication skills including telephone, email, face to face
- Willing to take on/learn new skills.
- Good attention to detail and proven accuracy.
- Ability to adapt to change.
- Ability to work under pressure.
- Ability to store and safeguard confidential documents.
Desirable
- Ability to extract, analyse and interpret clinical information for trials/research purposes.
Additional Requirements
Essential
- The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of safe, kind, excellent
Person Specification
Qualifications
Essential
- Educated to degree level or equivalent in relevant subject Service/ Business Admin /ITQ or equivalent
Desirable
- Evidence of continuing professional development in administration processes / data management
Experience
Essential
- In depth current knowledge and experience of the setting up process of cancer clinical trials
- Experience of data collection within a scientific or medical environment
- Experience of using clinical trials database.
- Prioritising, planning and organising own tasks
- Experience of working autonomously within guidelines and to tight deadlines
- Experience of using own initiative and working independently
- Experience of working across the MDT
- Experience of liaising with external agencies
Desirable
- Experience of audit.
- Participation in site initiation visits
- Training other members of staff
Knowledge
Essential
- Sound understanding of ethical and quality standards applicable to clinical trials, including EU directive, ICH GCP
- GCP trained
- Excellent working knowledge of Microsoft Office packages
- Understanding of confidentiality and data protection
Desirable
- Interrogation of data base to produce relevant reports
Skills
Essential
- Ability to work in a team.
- Good communication skills including telephone, email, face to face
- Willing to take on/learn new skills.
- Good attention to detail and proven accuracy.
- Ability to adapt to change.
- Ability to work under pressure.
- Ability to store and safeguard confidential documents.
Desirable
- Ability to extract, analyse and interpret clinical information for trials/research purposes.
Additional Requirements
Essential
- The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of safe, kind, excellent
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.
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).
Additional information
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.
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
Hills Road
Cambridge
CB2 0QQ
Employer's website
https://www.cuh.nhs.uk (Opens in a new tab)