Clinical Trials Monitor

We are seeking a Clinical Trials Monitor to join the Cambridge Clinical Trials Unit (CCTU) Regulatory Team.

The Clinical Trials Monitor 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, and all applicable Clinical Trials Regulations.

You will work with colleagues in the CCTU and the R&D office to support monitoring provision of Trust Sponsored Clinical Trials, and support for clinical researchers, under the guidance of a Senior Clinical Trial Monitor.

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 be required to travel and stay overnight for on-site monitoring visits in line with the requirements of the trials., Responsible for monitoring the conduct, documentation and progress of each clinical trial by performing source data verification (SDV) and ensuring that essential site file documents and pharmacy records are up to date in accordance with the requirements of GCP.

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

Analyse any potential problems and make recommendations to rectify these under the guidance of the Senior Clinical Trial Monitor.Perform external on-site monitoring visits as deemed necessary by the trial risk assessment under the guidance of the Senior Clinical Trial Monitor.

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

Maintain up to date knowledge of clinical trial regulations and developments regarding clinical trials monitoring.

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.