Senior Clinical Research Associate - Biotech
|Job Title:||Senior Clinical Research Associate - Biotech|
|Salary:||Up to £40,000 D.o. E plus excellent benefits|
|Contact Name:||James Hume|
|Job Published:||July 24, 2018 15:18|
The company is a centre of excellence with over 170 staff that is at the forefront of creating a viable and sustainable cell and gene therapy industry in the UK by bridging the gap between science and commercialisation. Their headquarters are in central London where they have built a sector leading multidisciplinary team that has the ability to take a therapy from concept through the development cycle to the market. They offer cutting edge technology and innovation to support companies taking their products to clinical trials then through this process across all phases to launch. They were the first to take a therapy to phase II clinical trials and have an expanding pipeline that covers trials from early phases through to phase III. Paving the way for others to follow working with the NHS and Commercial partners using sites within the UK and EU.
The purpose of the Senior CRA is to be responsible for the performance of trial sites in line with Good Clinical Practice, ICH guidelines, and EU regulations. You will be reporting the Head of Clinical Operations and be responsible for the site qualification, initiation, monitoring and close out. As well as contributing to monitoring plans, other trial site documentation, tools, with ongoing reporting responsibilities the recruitment and overall site including document management.
Due to the seniority of this role the Senior CRA will be the main liaison between the CRA’s, Project Management, Pharmacovigilance, Medical Monitor and Central Laboratories to support quality reporting and query management. To ensure that communication between all parties is clear, relevant, up to date and effective. Aside from the day to day trial related responsibilities you will be acting as the mentor to more junior colleagues to support their development. Proactively taking part in their training and working as a mentor to help develop their careers. The company have a strong career development programme enabling you to gain the skills and have the opportunity to move to more senior or technical roles as they continue to grow.
Desired Skills and Competencies:
For this opportunity you will need to have experience of running clinical trials, preferably within the pharma / biotech / CRO environments where you have had the responsibility for managing site performance in line with clinical trial execution. You will need to have had experience of 3 to 4 years site monitoring experience along with in depth knowledge of ICH, GCP, CFR, and EU Directives. If you have experience of cellular therapies then this is an advantage to your application as is working in a small company environment. You will need to be educated to at least degree level in a relevant life science, pharmacy or other health related discipline.