Vaccine and Trials Research Laboratory Coordinator - London, United Kingdom - Guy's and St Thomas' NHS Foundation Trust

Description

Job summary

This unique post offers an exciting opportunity to work as the Laboratory Coordinator for the Vaccine and Trials Research Team at Guy's and St. Thomas' NHS Foundation Trust.

The team manages a broad portfolio of Vaccine and Trials Research studies, requiring a comprehensive and high quality laboratory service including sample reception, preparation, processing, storage and shipment for samples collected as part of a complete portfolio of clinical trials of all phases and including in-patient, out-patient and healthy volunteer 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:

The post holder will oversee equipment maintenance, repair and calibration. They will work with the CRF laboratory co-ordinator and ensure adherence to Temperature monitoring systems and processes related to fridge/freezer alarms and out-of-hours laboratory storage.

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:

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 responsibilities

Management 1. Manage the flow and organisation of work coming through the labs, 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 Using the departmental database (CRF Manager), oversee the weekly laboratory schedule and coordinate the work of laboratory staff and service users to ensure the most economical use of resources, space and Liaise with colleagues to ensure standardised lab checks are Oversee the booking of couriers and dry Contribute to the investigation of complaints pertaining to the CRF lab and report the findings to the CRF Management Plan and prioritise own workload making adjustments to plans according to unforeseen Appropriately and fairly delegate duties, tasks and responsibilities to Medical Lab Assistant(s) (MLA) and other members of the Ensure the efficient use of laboratory consumables, chemicals and agents by monitoring stock levels (being aware of rotation, storage requirements, batch numbers and expiry dates) and being responsible for the ordering and preparation of consumables and reagents required for the laboratory. This will include the management of generic laboratory supplies and study specific laboratory/sample kits Purchase generic laboratory Ensure all sample records are adequately stored and accessible by members of the research Track laboratory Ensure personal and laboratory compliance with national and local guidance regarding commercial Ensure the laboratories are clean and tidy at all times and maintained to the required standard.

Equipment 1. Be responsible for the safe and effective use of laboratory equipment2. Ensure fitness-for-purpose checks are performed on a regular basis on existing and newly purchased Ensure Laboratory equipment, freezers and fridges are organised according to local policy and that they are maintained according to daily/weekly/monthly Proactively identify and manage issues relating to breakdown/unavailability of laboratory equipment, carry out corrective actions independently as appropriate and develop contingency plans as Liaise with the Trust Estates and Facilities and Biomedical Engineering department regarding acceptance, installation and testing of laboratory Take responsibility for ensuring Laboratory equipment repair, servicing and calibration occur within the set timeframe and documentary evidence of these visits is supplied and Be responsible for ensuring maintenance contracts and warranties are in place for laboratory Participate in the evaluation of new equipment and service contracts.

Temperature controlled storage and monitoring 1. Ensure IMP, stock drugs, reagents, lab kits and samples are stored and/or shipped at appropriate temperatures as directed by manufacturer or Track storage of all temperature controlled items and report any out-of-range temperatures according to local SOPs and sponsor Manage the continuous temperature monitoring system for all temperature controlled storage including drug preparation rooms and fridges and freezers for samples and medicinal products.

People management 1. Motivate, encourage and mentor lower banded Laboratory staff and Laboratory users.

2. Provide professional leadership for staff working within the Provide the day-to-day supervision of Medical Laboratory Assistant(s) (MLA).4. Provide appropriate induction, mentoring, supervision and input into the ongoing professional and personal development for team Review and sign off on leave requests from direct reports always ensuring sufficient service provision during times of personal and staff Cover for staff shortages as far as is reasonable, in order to maintain the Contribute to the recruitment of staff as Oversee the training and development needs of lower banded Laboratory Ensure regulatory and Trust mandatory training is up to date for all direct Manage and undertake objective setting and annual performance development reviews (PDR) for direct Contribute to a working environment which encourages staff to identify concerns and speak up.

Corporate responsibilities 1. Contribute to the effective corporate leadership and management of the team2. Help create a culture for the team underpinned by an ethos of continuous Promote the BRC through own actions and visibility in the NIHR BRC and with key internal and external Work collaboratively with colleagues across the BRC and wider GSTFT and KCL to facilitate the achievement of objectives and shared learning.

Technical 1. Ensure that specimens and forms are adequately labelled before being accepted into the laboratory and to resolve problems arising from incorrectly or inadequately labelled specimens and Ensure personal, staff and laboratory users appropriate handling, use and disposal of patient/participant tissue in accordance with the Human Tissue Authority (HTA) 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 Maintain concentration when performing complex sample processing, including multiple aliquot requirements to ensure the right sample is pipetted into the right numbered tubes and processing is completed within the sponsor specified time Be responsible for the appropriate and safe transport of research samples as dictated by each Take responsibility for sample preparation accuracy for all samples processed in the Work with the Management Team to develop new laboratory services and expand the type of samples that can be processed in the Laboratory.

Study/trial feasibility and set up 1. Understand all new research protocols and lab manuals, identifying any aspects that may require additional feasibility testing or additional training for laboratory and research Provide advice regarding sample management pathways and internal/inter-departmental transport Create study-specific SOPs and Work Instructions where Consult sponsor and Quality Assurance team prior to implementation of locally created study Document the review of laboratory activities within the established on-boarding and study set up Contribute to the costing of all Ensure laboratory staff attendance at all Site Initiation Visits (SIV) for studies.

Health and Safety 1. Be responsible for providing new Laboratory users an Induction Programme, providing advice on safe waste disposal and decontamination, enhanced personal protection, and contamination Work in a safe manner with regard to the safety of self and others, complying with appropriate Codes of Conduct and local safety Ensure safe handling and storage of hazardous materials in accordance with COSHH Complete risk assessments of activity carried out in the sample laboratory adhering to Trust procedures and, where necessary, seek guidance from Trust Biological Safety Office (BSO)/Health and Safety team5. Oversee the safe and compliant handling of human biological samples (including relevant material) using appropriate containment procedures. This may include working with limited risk Hazard Group 3 material such as samples positive for, COVID-19, HIV or Hepatitis Disseminate and ensure compliance with study-specific risk management Be responsible for maintaining and updating the laboratory Health and Safety policies as Be responsible for ensuring all staff using the laboratory have read and signed the appropriate policies and SOPs and completed the relevant lab Be responsible for ensuring sufficient provision of PPE for all laboratory Report any accidents/incidents or ill health and failings in premises, equipment or personal protective equipment.

11. Work in accordance with good clinical laboratory practices and local safety and quality Oversee the removal of clinical Notify management team of any changes required to waste management Deal with spillage of samples/chemicals in a safe and appropriate manner when necessary.

Qualifications/ Education

Essential

Desirable

Previous experience

Essential

Desirable

Skills/ Knowledge/ Ability

Essential

Desirable