The post holder will provide training and assistance to staff working in and utilising the CRF laboratory. They will support the work of the CRF team to ensure the delivery of a comprehensive, high quality service within the CRF in accordance with Trust Policies, the CRF’s Quality Management System (QMS), Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP) and all other regulatory requirements.
Our Research and Development (R&D) department is expanding its Good Clinical Laboratory Practice (GCLP) infrastructure. As part of our assurance processes, the CRF Laboratory will be managed under the umbrella of the R&D GCLP Laboratory.
The post holder will contribute to the implementation, monitoring, improving and management of the CRF’s Quality Management System (QMS) as it pertains to the CRF laboratory and support its alignment with the R&D GCLP Laboratory standards.
The CRF Laboratory Coordinator will have a line of professional accountability to the GCLP Manager to support their development and oversee their performance.
The successful applicant will be part of the Clinical Research Facility (CRF) team undertaking trials within the Royal Free London NHS Foundation Trust. They will liaise closely with CRF team members, clinical trial delivery staff, UCL-RFH Biobank personnel, study sponsor representatives and central analytical laboratories. They will be expected to operate with minimum supervision in organising and planning their own work activities.
ROYAL FREE LONDON NHS FOUNDATION TRUST
Royal Free London (RFL) NHS Foundation Trust is one of the largest foundation trusts in the country employing over 10,000 staff and serving a local population of over 1.6 million people. Beyond this, patients from across the country access our specialist services in liver and renal disease, cancer, organ transplantation, HIV and infectious diseases, immunology, cardiology, amyloidosis, scleroderma and single-gene disorders including haemophilia and lysosomal storage disorders (LSD).
Comprising three teaching hospitals – Barnet Hospital (BH), Chase Farm Hospital (CFH) and Royal Free Hospital (RFH) – the trust has over 1,300 beds and hosts 1.6 million patient visits per year. The RFL CRF will support investigators and serve patients from all three hospitals.
THE ROYAL FREE LONDON CLINICAL RESEARCH FACILITY (RFL CRF)
The CRF is located on the second floor of the Royal Free Hospital in Hampstead in North London.
The CRF is a purpose-built facility where investigators can deliver early-phase, complex and high-risk experimental medicine studies in healthy adults or those with acute, complex, and long-term conditions. These studies range from First in Human (FIH) to late-phase trials with an experimental medicine component that requires specialist facilities or support.
Please refer to the job description and person specification for full details of the roles and responsibilities of the job.
- Demonstrable ability to meet the Trust Values
- Degree in a scientific/healthcare related discipline or equivalent experience
- Evidence of Continuing Professional Development (CPD)
- Recent experience of handling of relevant human material in a routine diagnostic clinical or research laboratory
- Experience of working to Human Tissue Act (2004) guidelines
- Experience of general laboratory maintenance, organisation and stock management
- Experience of manual handling tasks
- Experience of handling confidential data
- Experience of project management
- Experience of working in a multi-disciplinary team
- Demonstrable knowledge of regulations governing clinical trials including: Human Tissue Act (2004), Data Protection Act (2018), Medicines for Human Use (Clinical Trial) Regulations (2004), Good Clinical Laboratory Practice (GCLP) and Good Clinical Practice (GCP)
- Competence in a Laboratory Information Management System (LIMS)
- Methodical and accurate approach to work showing excellent attention to detail
- Excellent communication skills both orally and in writing
- Ability to work to deadlines and willingness to work under pressure from time to time
- Possess good IT skills including the Microsoft Office suite, file management systems and a willingness to keep skills up to date
- Ability to keep accurate records and maintain databases
- Demonstrable knowledge of audit processes
- Knowledge of medical terminology
- Ability to problem solve and to work using own initative
- Displays a professional attitude towards colleagues, study PIs, clinical staff and others
- Flexible attitude to work, including the ability to take up new tasks when required
- Conscientious attitude to the finalisation of any given task
- Ability to work flexible hours including unsocialble hours
Applications are welcome from people wishing to job share or work flexible patterns. We are committed to equal opportunities.
Please note:
- Due to the high number of applications that are received for some posts we may close this vacancy before the advertised closing date. Therefore please apply for this post as soon as you can, if you are interested and you meet the requirements of the Person Specification
- Only those candidates who clearly demonstrate how they meet the person specification will be shortlisted for this job.
- Interview arrangements will be communicated via email so please check your email regularly following the closing date.
Please be advised that due to exceptionally high demand, all Royal Free accommodation is at full capacity and waiting lists are being held. Average waiting times are 12 months. Please do not rely on Trust accommodation when you commence your role and ensure you investigate alternative accommodation for your arrival.