Job summary
An exciting opportunity has come up to join the Cambridge Clinical Trials Unit (CCTU). The CCTU is a UKCRC Registered Clinical Trials Unit and caters for all investigators of Cambridge University Health Partners (CUHP), and beyond and has responsibility for new and existing clinical trials and clinical research projects on the CCTU portfolio, including Clinical Trials of Investigational Medicinal Products under the EU Directive (CTIMPS).
Main duties of the job
The key job functions of the Clinical Trials Coordinator are:
- To facilitate and co-ordinate the set-up and conduct of clinical trials and/or clinical studies working closely with the chief investigators and their teams
- To have responsibility for setting-up participating sites in multi-centre trials and ensuring that all data and samples are collected following the protocol
- To work in compliance with the International Conference on Harmonisation Good Clinical Practice Guidelines (ICH-GCP), the NHS Research Governance Framework for Health & Social Care and, in the case of a CTIMP, in compliance with the Medicines for Human Use (Clinical Trials) Regulations 2004.
Please see the job description for more detailed duties.
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 at midnight on 17th July 2024
Interviews are due to be held on 24th July 2024
Benefits to you
We offer development opportunities and a wide range of benefits including on-site leisure facilities, shopping concourse, day nurseries and access to a great transport system with easy access to airports and rail travel.
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 at midnight on 17th July 2024
Interviews are due to be held on 24th July 2024
Benefits to you
We offer development opportunities and a wide range of benefits including on-site leisure facilities, shopping concourse, day nurseries and access to a great transport system with easy access to airports and rail travel.
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 graduate or equivalent level of knowledge and experience.
- Recent ICH GCP training.
Desirable
- Evidence of post-graduate training in relevant field, and/or continuous professional development in relevant fields.
Experience
Essential
- Experience of working in a clinical research/ healthcare environment.
- Experience of working in an ICH GCP/EU Clinical Trials Directive environment.
- Experience with databases.
- Previous direct clinical trials and/or project management experience.
Desirable
- Line management experience.
Knowledge
Essential
- Knowledge of the requirements of clinical trials during their life-cycle from set-up to close-out.
- Ability to present data in a clear, simple format.
- Ability to use Microsoft Office to an advanced level.
- Competence in using the internet and email.
- Knowledge of clinical trials regulatory framework.
Desirable
- Clinical trials terminology and essential documentation.
- Study design.
- Knowledge of the clinical trials regulatory framework.
- An understanding of the clinical research approval process in the NHS.
Skills
Essential
- Excellent administrative skills including organising and planning
- Excellent communication skills.
- Excellent attention to detail.
- Helpful, outgoing team worker.
- Excellent interpersonal, professional and motivational skills with the ability to build working relationships with internal and external departmental and Trust colleagues.
- Ability to work under pressure, prioritise and seek input where necessary.
- Ability to work independently with initiative and motivate self and others.
- Ability to maintain confidentiality.
- Ability to negotiate, acting in a tactful and confident manner to achieve the desired results.
Desirable
- Problem solver
- Focused, starter-finisher
- Willing to coach and train others
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.
- Flexible approach to working and a desire to develop knowledge and career.
- Can demonstrate autonomous working practices in current post.
- Problem solver.
- Focused, starter-finisher.
- Willing to coach and train others.
- Ability to travel to participating sites to conduct on-site visits.
Person Specification
Qualifications
Essential
- Science graduate or equivalent level of knowledge and experience.
- Recent ICH GCP training.
Desirable
- Evidence of post-graduate training in relevant field, and/or continuous professional development in relevant fields.
Experience
Essential
- Experience of working in a clinical research/ healthcare environment.
- Experience of working in an ICH GCP/EU Clinical Trials Directive environment.
- Experience with databases.
- Previous direct clinical trials and/or project management experience.
Desirable
- Line management experience.
Knowledge
Essential
- Knowledge of the requirements of clinical trials during their life-cycle from set-up to close-out.
- Ability to present data in a clear, simple format.
- Ability to use Microsoft Office to an advanced level.
- Competence in using the internet and email.
- Knowledge of clinical trials regulatory framework.
Desirable
- Clinical trials terminology and essential documentation.
- Study design.
- Knowledge of the clinical trials regulatory framework.
- An understanding of the clinical research approval process in the NHS.
Skills
Essential
- Excellent administrative skills including organising and planning
- Excellent communication skills.
- Excellent attention to detail.
- Helpful, outgoing team worker.
- Excellent interpersonal, professional and motivational skills with the ability to build working relationships with internal and external departmental and Trust colleagues.
- Ability to work under pressure, prioritise and seek input where necessary.
- Ability to work independently with initiative and motivate self and others.
- Ability to maintain confidentiality.
- Ability to negotiate, acting in a tactful and confident manner to achieve the desired results.
Desirable
- Problem solver
- Focused, starter-finisher
- Willing to coach and train others
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.
- Flexible approach to working and a desire to develop knowledge and career.
- Can demonstrate autonomous working practices in current post.
- Problem solver.
- Focused, starter-finisher.
- Willing to coach and train others.
- Ability to travel to participating sites to conduct on-site visits.
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)