Job summary
This unique post offers an exciting opportunity to work as the Laboratory Coordinator in the NIHR Clinical Research Facility (CRF) at Guy's and St. Thomas' NHS Foundation Trust.
The CRF Laboratory provides a comprehensive and high quality service including sample reception, preparation, processing, storage and shipment for samples collected as part of a complete portfolio of clinical trials implemented at the CRF ranging from First in Human (FIH) through to innovative phase 3 trials, and experimental non-IMP studies across a combined adult and paediatric service
Main duties of the job
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;
- maintaining study data documentation;
- overseeing laboratory checks;
- facilitating scheduled internal audits;
- performing quality control checks on routine equipment;
- completing feasibility assessments and laboratory costings;
- contributing to COSHH and Risk Assessments (as required and appropriate);
- dealing with enquiries;
- preparing weekly laboratory work schedules.
About us
The R&D Department at Guy's & St Thomas' NHS Foundation Trust (GSTFT) is one of the focal points for innovative research in London through its nationally recognised research portfolio and research infrastructure. We are systems leaders in NHS research with strong strategic partnerships across the National Institute for Health Research (NIHR), Department of Health & Social Care (DHSC) and the Health Research Authority (HRA) and are active members of the organisations such as the Shelford Group, University Hospitals Association (previously AUKUH) and UKRD. Research is a top priority for the Trust which in 2021/22 was the top NHS organisation nationally for the number of NIHR portfolio studies open (417) and was the top recruiting organisation in South London (third nationally) recruiting over 19,000 participants into NIHR portfolio studies.
Our research infrastructure includes our NIHR Clinical Research Facility (CRF) located St Thomas' Hospital, Guy's Hospital, Evelina London Children's Hospital and the Royal Brompton Hospital; the Guy's Phase I unit is an MHRA Accredited Phase I Unit (1 of only 2 NHS managed Units in England). Within the Biomedical Hub at Guy's Hospital, the NIHR CRF is co-located with our Advanced Therapies Manufacturing (GMP) Unit; the Advanced Therapies Accelerator houses our Immune Monitoring Platform and Genomics Platform.
Job description
Job responsibilities
- Coordinate and support the laboratory activity within the CRF laboratories on the 15th floor of Tower Wing at Guys Hospital (near London Bridge), the 4th floor of St. Thomas Hospital (near Westminster/Waterloo) and the 1st floor of Evelina London (on St. Thomas campus).
- Manage the flow and organisation of work coming through the CRF lab, ensuring that work is carried out in a timely and efficient manner, in accordance with the laboratory manual and to the appropriate standards and regulations for research and the use of human tissue.
- Purchase generic laboratory consumables using the CRF standard stock order procedure. Ensure all sample records are adequately stored and accessible by members of the research teams.
- Track laboratory usage and provide reports on activity and temperature excursions to the CRF Management Team, study teams, sponsors and other teams as needed.
- Ensure personal, staff and laboratory users appropriate handling, use and disposal of patient/participant tissue in accordance with the Human Tissue Authority (HTA) guidelines.
- Carry out sample receiving, preparation, processing, coding, logging and shipping, as set out in the study protocol and laboratory manual, adhering to current ICH Good Clinical Practice (ICH GCP) guidelines and the Human Tissue Act.
- Understand all new research protocols and lab manuals, identifying any aspects that may require additional feasibility testing or additional training for laboratory and research staff
- Contribute to the costing of all studies using the CRF laboratories.
Job description
Job responsibilities
- Coordinate and support the laboratory activity within the CRF laboratories on the 15th floor of Tower Wing at Guys Hospital (near London Bridge), the 4th floor of St. Thomas Hospital (near Westminster/Waterloo) and the 1st floor of Evelina London (on St. Thomas campus).
- Manage the flow and organisation of work coming through the CRF lab, ensuring that work is carried out in a timely and efficient manner, in accordance with the laboratory manual and to the appropriate standards and regulations for research and the use of human tissue.
- Purchase generic laboratory consumables using the CRF standard stock order procedure. Ensure all sample records are adequately stored and accessible by members of the research teams.
- Track laboratory usage and provide reports on activity and temperature excursions to the CRF Management Team, study teams, sponsors and other teams as needed.
- Ensure personal, staff and laboratory users appropriate handling, use and disposal of patient/participant tissue in accordance with the Human Tissue Authority (HTA) guidelines.
- Carry out sample receiving, preparation, processing, coding, logging and shipping, as set out in the study protocol and laboratory manual, adhering to current ICH Good Clinical Practice (ICH GCP) guidelines and the Human Tissue Act.
- Understand all new research protocols and lab manuals, identifying any aspects that may require additional feasibility testing or additional training for laboratory and research staff
- Contribute to the costing of all studies using the CRF laboratories.
Person Specification
Qualifications and Knowledge
Essential
- Biomedical Science degree, or equivalent knowledge, skills and experience
- Current GCP and GCLP
Desirable
Experience
Essential
- Previous experience of working in a research laboratory handling and preparing samples for research studies/clinical trials
- 3 years post qualification experience
- Experience of training others
- Experience of contributing the development and implementation of laboratory working practices and Standard Operating Procedures (SOPs)
Desirable
- Knowledge of Quality Management Systems (QMS)
- Line Management experience
- Experience of external audit/inspections
- Experience working in a MDT
- Experience of early phase clinical trials
Skills
Essential
- Proficient in sample preparation, processing, storage and shipping. Competent to advise others on these processes
- Good understanding of laboratory and clinical terminology
- Ability to acquire in-depth knowledge of trial laboratory and advise on study set up as it pertains to laboratory processes
- Understands the importance and role of audit and can demonstrate knowledge of audit processes
- Proven ability to make decisions, organise and prioritise own work in a busy work environment and time critical situations
- Able to supervise staff and appropriately and fairly delegate
Desirable
- An understanding of the commercial research environment and the expectations of its stakeholders
- Awareness of current MHRA inspection standards for laboratories supporting clinical trials
Person Specification
Qualifications and Knowledge
Essential
- Biomedical Science degree, or equivalent knowledge, skills and experience
- Current GCP and GCLP
Desirable
Experience
Essential
- Previous experience of working in a research laboratory handling and preparing samples for research studies/clinical trials
- 3 years post qualification experience
- Experience of training others
- Experience of contributing the development and implementation of laboratory working practices and Standard Operating Procedures (SOPs)
Desirable
- Knowledge of Quality Management Systems (QMS)
- Line Management experience
- Experience of external audit/inspections
- Experience working in a MDT
- Experience of early phase clinical trials
Skills
Essential
- Proficient in sample preparation, processing, storage and shipping. Competent to advise others on these processes
- Good understanding of laboratory and clinical terminology
- Ability to acquire in-depth knowledge of trial laboratory and advise on study set up as it pertains to laboratory processes
- Understands the importance and role of audit and can demonstrate knowledge of audit processes
- Proven ability to make decisions, organise and prioritise own work in a busy work environment and time critical situations
- Able to supervise staff and appropriately and fairly delegate
Desirable
- An understanding of the commercial research environment and the expectations of its stakeholders
- Awareness of current MHRA inspection standards for laboratories supporting clinical trials
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).
