Social Care Officer

1 week ago

Cambridge, Cambridgeshire, United Kingdom Cambridge University Hospital NHS Foundation Trust Full time
This post is part of the Cambridge Clinical Trials Unit (CCTU) atCambridge University Hospitals NHS Foundation Trust.

TheCCTU caters for all investigators of Cambridge University Health Partners (CUHP), and has responsibility for new and existing Cambridge sponsored Clinical Trials of Investigational Medicinal Products under the EU Directive (CTIMPs) and other clinical research projects on the CCTU portfolio.

The post holder is part of the Quality Assurance team and the Clinical Trials Officer provides expert support for the review and set up of these clinical trials as well as the ongoing management to ensure they are conducted in compliance with Clinical Trial Regulations.

The key job functions of the Clinical Trials Officer are:


To act as a point of contact for researchers, offering guidance and support to all stakeholders so that clinical trials are managed and conducted in line with SOPs, legal and regulatory requirements.

To support researchers and research teams in the set-up of CTIMPs and preparing submissions to the regulatory agencies (MHRA, REC and Trust R& D).


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.

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 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.

This vacancy will close at midnight on the 16th June 2024.


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.

Current ICH GCP Training.

Evidence of post-graduate training in relevant research field.


Significant and demonstrable experience of working in a Sponsored CTIMP central project management/coordination role in a commercial or NHS environment.

CTIMP Regulatory documentation generation and submission experience, especially initial submissions.

Previous experience of CTIMP Risk Assessment processes.

Knowledge of regulatory requirements for Sponsors for CTIMPs.
Knowledge of the clinical trials regulatory framework.

Excellent administrative skills including organising and planning. Flexible approach to working and a desire to develop knowledge and career.

Cambridge University Hospital NHS Foundation Trust

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