Profile:
Our client is looking for a field based Clinical Research Associate to cover sites in Birmingham and Manchester. Working on an Oncology study you will be responsible for the monitoring of phase I/II client trials at site, in order to ensure compliance with internal policies and ICH/GCP guildlines.
Responsibilities:
· To maintain relations with site personnel, and to ensure all site activities relating to the clinical trial are in compliance with policies
· Ensures there are sufficient supplies of the investigational product and orders new supplies if necessary.
· Ensures adequate storage of samples taken (e.g. PK samples) and their shipment to the relevant laboratories.
· Ensures that the Investigator Trial File (ITF), Trial Master File (TMF) and Pharmacy File are kept up to date at site and in the office.
· Escalates any ongoing or serious issues to the Clinical Project Manager (CPM) and other appropriate team members (e.g. Clinical Research Manager, Investigator at site)
Work experience needed:
Biological Sciences degree or equivalent nursing qualification/ experience.
Working knowledge of ICH/GCP, EU legislation and clinical trial methodology.
Experience in monitoring early phase (non healthy volunteers) or late phase clinical trials is essential.
Experience in Oncology would be beneficial.
For more information please contact Natasha on 0207 5621791
The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the country where the job is based. Carlisle Staffing plc, trading as SRG is an Employment Business/Agency.
| Consultant: |
Natasha Grace |
