Clinical Trials Monitor

Applications are invited for the post of Clinical Trials Monitor at the Cambridge Clinical Trials Unit (CCTU), which provides support for clinical trials within the Cambridge Biomedical Research Centre.

You will have responsibility for the essential monitoring of non-commercial clinical trials sponsored by Cambridge University Hospitals NHS Foundation Trust to ensure compliance in accordance with Good Clinical Practice (GCP) Guidelines, the Research Governance Framework for Health & Social Care (2005) and the Medicines for human Use (Clinical Trials) Regulations 2004.

You will also ensure that the rights of patients involved in research are protected in accordance with the Data Protection Act, Human Rights legislation and GCP.

You will work with colleagues in the Cambridge Clinical Trials Unit (CCTU) to support monitoring provision of Trust Sponsored Clinical Trials, and support for clinical researchers, under the guidance of a Senior Clinical Trial Monitor.

The monitor will be required to travel and stay overnight periodically in line with the requirements of the trials.

Main duties of the job

Developing clinical trials monitoring plans based upon the clinical trial Risk Assessment and an understanding of the key trial documentation for all trials as required.

Responsible for monitoring the conduct, documentation and progress of each clinical trial by performing risk based monitoring in accordance with the trial Monitoring Plan.

Complete written monitoring visit reports on the progress, management and conduct of clinical trial undertaken at the Trust.

Maintain participating site oversight by reviewing remote monitoring in accordance with CCTU SOPs and controlled documents.

Perform on-site monitoring visits as deemed necessary by the trial Risk Assessment and monitoring plan.

Participate in the development and management of systems including Standard Operating Procedures, R&D Policies and Procedures for CTIMPs sponsored by the Trust.

Our Trust

Cambridge University Hospitals (CUH) NHS Foundation Trust comprises Addenbrooke's Hospital and the Rosie Hospital in Cambridge. With over 12000 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.