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 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 co-ordinate 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 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 Job Description and Person Specification documents for key duties and responsibilities.

This vacancy will close at midnight on the 29th May 2023.

Interviews are due to be held on the 13th June 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

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.

Any attachments will be accessible after you click to apply.

180-RD-235064-RE