Alex Dobson is recruiting for an exciting Senior CRA opportunity that is ideal for someone with 5 or more years’ experience running clinical trials within a pharmaceutical, biotechnology or CRO organization. Ideally you should have 3 years’ experience related to the management of the site performance and monitoring of the clinical trial. The salary is up to £40,000 plus bonus, 15% pension, life insurance, PHI and other flexible benefits. You will be based in an easily accessible area of Central London, a short walk from London Bridge station.
The company are a Centre of Excellence that is at the forefront of creating a viable and sustainable cell and gene therapy industry in the UK. Their headquarters are in Central London (within a short walk of London Bridge station) where they have built a market leading multidisciplinary team that has the ability to take a therapy from concept through the development cycle to the market. They collaborate with both academia and industry and they are able to provide the scientific, clinical and commercial expertise needed to overcome the challenges that hinder the commercialization of these fast developing, cutting edge technologies. Their longer term aim is to make the UK a global leader in the development and commercial exploitation of therapies. They are making great strides towards this aim with therapies entering phase 2 clinical trials and building credible cases to be progressed to stage 3. Added to this they are expanding their manufacturing and development operations to meet increased demand for their services from the academic and commercial sectors.
The purpose of this role is to be responsible for the performance of trial sites in accordance with Good Clinical Practice (GCP), ICH guidelines and EU regulations. This includes site qualification, initiation, monitoring and closeout. Reporting to the Head of Clinical Operations, the Senior Clinical Research Associate will contribute to monitoring plans and other trial site documents and tools with ongoing reporting responsibilities for progress of recruitment and overall trial site including document management.
The Senior CRA will also act as primary liaison between CRAs and Project Managers, assisting in the mentoring, oversight and training responsibilities. In addition you will also be expected to work in close collaboration with data management, pharmacovigilance, medical monitor and central laboratories to support query management and quality reporting.
In addition to a generous salary, you will receive the following benefits:
- 28 days annual leave + bank holidays
- Performance-related annual bonus
- Travel Loan (after probation)
- Cycle to work scheme
- Contributory pension (after probation)
- Death in service at 4x salary (after probation)
- Private healthcare (after probation)
- Childcare Vouchers
- Eyecare vouchers
- Approximately 5 years’ experience in running clinical trials, ideally within pharmaceutical, biotechnology or CRO and / or healthcare setting, of which 3 – 4 years must be where the previous roles were directly related to the management of site performance in accordance with clinical trial execution.
- A minimum of 3-4 years of site monitoring experience required.
- Monitoring experience of cellular therapies or relevant experience will be given special consideration.
- Versed in building relationships with current and potential investigators.
- Exposure of working within a small and / or start-up organization would be advantageous.
- Skilled in managing a varied and complex workload.
This is a permanent position