Job summary
The Cambridge Clinical Trials Unit (CCTU) is part of the NIHR UKCRC Registered CTU Network with the remit to provide support for all aspects of clinical trials from set-up to close down within the Cambridge Biomedical Research Centre.
Applications are invited for the post of Clinical Trials Coordinator at the Cambridge Clinical Trials Unit (CCTU) which provides support for clinical studies within the Cambridge Biomedical Research Centre from concept and set up to close down.
Previous experience of working in a clinical research environment within the NHS, University or pharmaceutical industry is essential for this post.
Main duties of the job
Supporting investigators in the planning, set-up and conduct of clinical research projects within the Trust including the preparation of REC, MHRA and R&D submissions and essential documentation. Ensuring that clinical research projects undertaken by CCTU are fully compliant with the applicable regulations and legislation as well as Trust SOPs and policies. You will be expected to develop relationships with investigators and members of research teams, support service personnel and external stakeholders at all levels, to ensure the efficient set-up and conduct of all CCTU portfolio projects. You will be working as part of a wider team, including providing advice and guidance to new researchers or members of the CCTU where appropriate.
About us
Our Trust
Cambridge University Hospitals (CUH) NHS Foundation Trust comprises Addenbrooke's Hospital and the Rosie Hospital in Cambridge. With over 11000 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
The post is not suitable for candidates looking for remote-only work as there is a requirement for office based working during at least part of the week.
This vacancy will close at midnight on the 29th October 2023.
Interviews are due to be held on the 2nd November 2023.
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
The post is not suitable for candidates looking for remote-only work as there is a requirement for office based working during at least part of the week.
This vacancy will close at midnight on the 29th October 2023.
Interviews are due to be held on the 2nd November 2023.
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
Knowledge
Essential
- Knowledge of the requirements of clinical trials and clinical research projects during their life-cycle especially at the start-up Stage.
- Use of databases to record data.
- Present data in clear and simple format.
- Use of Microsoft Office to an advanced level.
- Competence in using the Internet and E-mail.
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 and interpersonal 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.
Qualifications
Essential
- Science graduate or equivalent level of knowledge and experience.
Desirable
Experience
Essential
- Experience of working in a clinical research environment within NHS, University or pharmaceutical industry.
Desirable
- Previous direct clinical trial coordination and/or administration experience.
- Project management.
- Experience of working in an ICH GCP/EU Clinical Trials Directive environment.
Additonal 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.
Person Specification
Knowledge
Essential
- Knowledge of the requirements of clinical trials and clinical research projects during their life-cycle especially at the start-up Stage.
- Use of databases to record data.
- Present data in clear and simple format.
- Use of Microsoft Office to an advanced level.
- Competence in using the Internet and E-mail.
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 and interpersonal 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.
Qualifications
Essential
- Science graduate or equivalent level of knowledge and experience.
Desirable
Experience
Essential
- Experience of working in a clinical research environment within NHS, University or pharmaceutical industry.
Desirable
- Previous direct clinical trial coordination and/or administration experience.
- Project management.
- Experience of working in an ICH GCP/EU Clinical Trials Directive environment.
Additonal 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.
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).