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Job Description
Clinical Research Associate II (set-up specialist)
Job description
The King’s Health Partners Clinical Trials Office (KHP-CTO) is a joint initiative between the member institutions of King’s Health Partners. It was set up to provide a single interface for those wishing to conduct clinical trials within the partner institutions, and to ensure that there are common, efficient processes for the set up and administration of clinical trials. http://www.khpcto.co.uk
The KHP-CTO Quality Team was established in 2008 to manage the sponsor responsibilities for Clinical Trials of Investigational Medicinal Products (CTIMPs), as defined in the Medicines for Human Use (Clinical Trials) Regulations, for trials sponsored or co-sponsored by King’s Health Partner Organisations. The team assists Chief Investigators with the set-up, initiation, maintenance and closure of their trials and ensures that these trials are established and conducted according to Good Clinical Practice (GCP) and the Regulations.
We are looking for someone experienced to take the lead in setting up trials sponsored by KHP Organisations. The successful applicant will be required to review protocols for GCP and 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 and 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 and 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.
If you are an experienced CRA, we would like to hear from you.
This advertisement does not meet the requirements for a Certificate of Sponsorship under Home Office regulations; therefore, the university will not be able to offer sponsorship for this role.
This post will be offered on an indefinite contract
This is a full-time post – 100% full time equivalent