Clinical Trials Monitor | University Hospitals NHS Foundation Trust

Overview

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.

• Monitor the conduct, documentation and progress of each clinical trial by performing source data verification (SDV) and ensure that essential site file documents and pharmacy records are up to date in accordance with GCP requirements.
• Complete written monitoring visit reports on the progress, management and conduct of clinical trials undertaken at the Trust.
• Analyse 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.

Travel and overnight stays for on-site monitoring visits are required in line with trial requirements. You will work within the regulatory framework to ensure compliance with GCP and applicable regulations.

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. CUH is recognised as providing ‘outstanding’ care and rated ‘Good’ overall by the Care Quality Commission. CUH’s values – Together, Safe, Kind, Excellent – are at the heart of patient care and define how staff work and behave.

The Trust provides accessible high-quality healthcare for the local people of Cambridge, together with specialist services for regional, national and international populations.

CUH is committed to promoting a diverse and inclusive community. We value differences and advocate an inclusive working environment where every individual can fulfil their potential. We welcome applications for all positions irrespective of age, disability, ethnicity, race, nationality, gender identity, sex, sexual orientation, religion or belief, marriage and civil partnership status, pregnancy and maternity status or socio-economic background.

Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities.

Due to Home Office immigration rules, a full-time permanent vacancy cannot be filled by individuals on a Student visa. If you are a Student visa holder, we will not be able to offer a full-time permanent contract unless you have: applied for a Graduate visa; completed your course and applied for a Graduate visa before the anticipated start date; or the Trust has agreed to sponsor you as a Skilled Worker and you will complete your studies within 3 months of the anticipated start date of employment.

Internal applicants on permanent contracts may apply for this post as a secondment or fixed-term contract with line-manager approval. Internal applicants on a fixed-term contract may apply for a…