Job summary 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 end of trial. You will be expected to develop strong 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 required to work independently and as part of a wider team, including providing advice and guidance to new researchers or members of the CCTU where appropriate. 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 To facilitate and coordinate the set-up and conduct of clinical trials and/or clinical studies working closely with the chief investigators and their teams. This will include the preparation of REC, MHRA and R&D submissions and essential documentation. 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. 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. Date posted 08 November 2024 Pay scheme Agenda for change Band Band 6 Salary £37,338 to £44,962 a year p.a. pro rata Contract Fixed term Duration 24 months Working pattern Full-time, Part-time, Flexible working Reference number 180-RD-245491 Job locations Addenbrookes Hospital-Division R&D Cambridge Biomedical Campus Cambridge CB2 0QQ Job description Job responsibilities Please see the attached Job Description and Person Specification documents 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 November 2024 Interviews are due to be held on 28th November 2024 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 Job Description and Person Specification documents 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 November 2024 Interviews are due to be held on 28th November 2024 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 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. 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). 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. 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 Cambridge Biomedical Campus Cambridge CB2 0QQ Employer's website https://www.cuh.nhs.uk (Opens in a new tab)