A leading global pharmaceutical company with offices in Hertfordshire are looking for an experienced Senior Clinical Research Associate (CRA) to join them. This is an initial 12 month fixed term contract with in mind of going permanent. An excellent opportunity to work on ground breaking studies, initially in Sepsis, a very challenging and complex area of study.
Reporting to the Senior Manager/AD or Director, as a Senior Clinical Research Associate (SCRA) you will undertake 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. 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.
Working as a Senior Clinical Research Associate (SCRA) you will also be responsible for the quality of the data for those sites which he or she is assigned as monitor or co-monitor. You may work in UK, other European countries and may co-monitor in South Africa, Australia and New Zealand, India, and S.E. Asia. The successful candidate will be assigned to one or more therapeutic areas and will also participate in Group activities include revision of SOPs.
This Clinical Research Associate role demands either a good level of clinical monitoring experience in the UK or previous experience as a Clinical Trial Assistant and full understanding of currentICH/GCP guidelines. In return this leading pharmaceutical company offers a very competitive remuneration package applies, including car allowance and annual Bonus.
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