A Senior Clinical Research Associate (CRA) is required to join a leading global pharmaceutical company based in Hertfordshire, UK.
This Senior Clinical Research Associate (CRA) role is an initial 12 month fixed term contract with the possibility of becoming permanent and provides an excellent opportunity to work on ground breaking oncology study.
As a Senior Clinical Research Associate, you will report to the Senior Manager/AD or Director. Your main roles and responsibilities as a Senior Clinical Research Associate will include undertaking primary monitoring and/or co-monitoring of sites participating in studies in accordance with current ICH/GCP guidelines, local regulatory requirements and company SOPs/WPs.
The studies may be Phase I through to Phase IV on a European basis. All site co-ordination activities will also be undertaken including drug accountability and data resolution and the CRA will assist the site in Ethics Committee submissions and preparation of informed consent forms.
Where studies have been contracted to CROs for project and site management and monitoring the CRA will perform co-monitoring trips to sites with the monitors of the CRO and will liaise with these monitors regarding site issues.
The CRA will also be responsible for the quality of the data for those sites to which he or she is assigned as monitor or co-monitor.
As a CRA, you will also participate in Group activities including revision of SOPs and will be assigned to one or more therapeutic areas.
The CRA may work in UK, other European countries and may co-monitor in South Africa, Australia and New Zealand, India, and S.E. Asia.
The ideal candidate for this Senior Clinical Research Associate job will be a science graduate with solid experience of clinical monitoring and site co-ordination. This CRA role also demands a candidate with some experience in the UK and at least one other European country, preferably in a Lead CRA role, and full understanding of current ICH/GCP guidelines. Experience of Oncology clinical trials and tools (such as RECIST and NCI-CTC) is expected.
For more information, or to apply for this Senior Clinical Research Associate role, please contact Jim Gleeson on 01438 870027. Alternatively, please email copy of your CV to email@example.com for consideration.