Clinical Research Associate II (set-up specialist) - Maternity Cover

About us

The King’s Health Partners Clinical Trials Office is a collaboration between King’s College London, Guy’s & St Thomas’ NHS Foundation Trust, King’s College Hospital NHS Foundation Trust & South London and Maudsley NHS Foundation Trust. It was set up to provide a single interface for those wishing to conduct clinical trials within the partner organisations, and to ensure that there are common, efficient processes for the set up &  administration of clinical trials.

About the role

The successful applicant will be required to review protocols for GCP & operational compliance and take teams forward to application and initiation. The ideal applicant will also have experience of working independently with sites, performing source data verification & monitoring trials to GCP, as some site visits may be required. 

The post holder will be required to:

• Set up, initiate and on occasion monitor & close clinical trials on behalf of the sponsor where one or more of the partner institutions is acting as sponsor, to ensure regulatory compliance.
• Provide support to investigators conducting clinical trials sponsored by partner institutions to ensure they are set up and working to the highest quality standards and report on the progress of trials.

Ensure that investigators and their teams set up and, where applicable, run trials according to sponsor’s SOPs, prevailing regulations and best research practice by providing advice, practical assistance and carrying out set-up and monitoring functions as appropriate.

This is a full-time (35 hours per-week) post, offered on a fixed-term contract until 28/02/2027.

You will be based at Guy's Campus with the expectation to be on site 1-2 days per-week.

About you

To be successful in this role, we are looking for candidates to have the following skills and experience:

Essential criteria

• Significant experience of setting up and monitoring of clinical trials to GCP (including source data verification) OR significant experience in CTIMP trial management of multi-centre studies; in a pharmaceutical company, contract research organisation, NHS or academic setting.
• Educated to “A” level or degree level, preferably in a related subject area, e.g. a life science or clinical subject
• Sound working knowledge of the prevailing regulations and best research practices pertaining to the conduct of clinical trials, in particular GCP
• Strong planning and organisational skills including the ability to prioritise, manage multiple tasks & projects, with proven ability to deliver to stringent performance criteria.
• Strong interpersonal, communication, influencing and problem-solving skills including the ability to build successful relationships and collaborate in a cross-functional team and maintain a positive work environment
• Eye for detail and ability to accurately document findings in written reports
• Able to learn and work to SOPs and demonstrate a commitment to quality culture
• Willingness to travel nationally and internationally on occasion, including occasional overnight stays

Desirable criteria

• Experience across a range of therapeutic areas
• Experience and knowledge of working within the NHS Research Governance Framework.
• Experience of setting up clinical trials within the NHS/academic sector or within a pharmaceutical company
• Ability to understand and function in the different cultural environments of clinical researc

Downloading a copy of our Job Description

Full details of the role and the skills, knowledge and experience required can be found in the Job Description document, provided at the bottom of the next page after you click “Apply”. This document will provide information of what criteria will be assessed at each stage of the recruitment process.

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