Job summary
The NIHR Royal Free Clinical Research Facility (CRF) provides a designated facility for researchers to conduct clinical research studies involving both patient and healthy volunteers. As a CRF Laboratory Coordinator the post holder will have knowledge of a range of pre-analytical processing procedures and will be responsible for overseeing the processing and storage of clinical trial samples to the highest standard. This includes: receiving, sorting, labelling and processing samples; resolving issues such as mislabelled or missing specimens, performing pre-analytical processes, maintaining study data documentation, performing scheduled internal audits, performing quality control checks on routine equipment, contributing to COSHH procedures and risk assessments, dealing with enquiries and preparing laboratory work schedules. The post holder will also represent the CRF laboratory at pre-study visits and site initiation visits.
Main duties of the job
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.
About us
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.
Job description
Job responsibilities
Please refer to the job description and person specification for full details of the roles and responsibilities of the job.
Job description
Job responsibilities
Please refer to the job description and person specification for full details of the roles and responsibilities of the job.
Person Specification
Royal Free World Class Values
Essential
- Demonstrable ability to meet the Trust Values
Education & professional Qualifications
Essential
- Degree in a scientific/healthcare related discipline or equivalent experience
- Evidence of Continuing Professional Development (CPD)
Experience
Essential
- 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
Desirable
- Experience of project management
- Experience of working in a multi-disciplinary team
Skills and aptitudes
Essential
- 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
Desirable
- Demonstrable knowledge of audit processes
- Knowledge of medical terminology
Personal Qualities & attributes
Essential
- Ability to problem solve and to work using own initative
Personal Qualities & attributes
Essential
- 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
Other
Essential
- Ability to work flexible hours including unsocialble hours
Person Specification
Royal Free World Class Values
Essential
- Demonstrable ability to meet the Trust Values
Education & professional Qualifications
Essential
- Degree in a scientific/healthcare related discipline or equivalent experience
- Evidence of Continuing Professional Development (CPD)
Experience
Essential
- 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
Desirable
- Experience of project management
- Experience of working in a multi-disciplinary team
Skills and aptitudes
Essential
- 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
Desirable
- Demonstrable knowledge of audit processes
- Knowledge of medical terminology
Personal Qualities & attributes
Essential
- Ability to problem solve and to work using own initative
Personal Qualities & attributes
Essential
- 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
Other
Essential
- Ability to work flexible hours including unsocialble hours
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
