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    Data & Monitoring Coordinator - London, United Kingdom - Guy's and St Thomas' NHS Foundation Trust

    Guy's and St Thomas' NHS Foundation Trust
    Guy's and St Thomas' NHS Foundation Trust London, United Kingdom

    1 week ago

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    Description

    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 studies.

    receiving, sorting, labelling and processing samples
    maintaining study data documentation
    performing quality control checks on routine equipment
    contributing to COSHH and Risk Assessments

    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.

    receiving, sorting, labelling and processing samples
    maintaining study data documentation
    performing quality control checks on routine equipment
    contributing to COSHH and Risk Assessments (as required and appropriate)

    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.

    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 tissue.

    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 equipment.

    Contribute to the investigation of complaints pertaining to the CRF lab and report the findings to the CRF Management Team.

    Appropriately and fairly delegate duties, tasks and responsibilities to Medical Lab Assistant(s) (MLA) and other members of the team.

    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.

    Ensure all sample records are adequately stored and accessible by members of the research teams.
    Ensure personal and laboratory compliance with national and local guidance regarding commercial confidentiality.

    Ensure Laboratory equipment, freezers and fridges are organised according to local policy and that they are maintained according to daily/weekly/monthly checks.

    Liaise with the Trust Estates and Facilities and Biomedical Engineering department regarding acceptance, installation and testing of laboratory equipment.
    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 sponsor.

    Track storage of all temperature controlled items and report any out-of-range temperatures according to local SOPs and sponsor requirements.

    Manage the continuous temperature monitoring system for all temperature controlled storage including drug preparation rooms and fridges and freezers for samples and medicinal products.


    Provide the day-to-day supervision of Medical Laboratory Assistant(s) (MLA).Provide appropriate induction, mentoring, supervision and input into the ongoing professional and personal development for team members.

    Oversee the training and development needs of lower banded Laboratory staff.
    Ensure regulatory and Trust mandatory training is up to date for all direct reports.
    Manage and undertake objective setting and annual performance development reviews (PDR) for direct reports.
    Help create a culture for the team underpinned by an ethos of continuous improvement.

    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.

    Be responsible for the appropriate and safe transport of research samples as dictated by each study.

    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.

    Consult sponsor and Quality Assurance team prior to implementation of locally created study documents.
    Document the review of laboratory activities within the established on-boarding and study set up processes.

    Be responsible for providing new Laboratory users an Induction Programme, providing advice on safe waste disposal and decontamination, enhanced personal protection, and contamination management.

    Work in a safe manner with regard to the safety of self and others, complying with appropriate Codes of Conduct and local safety rules.

    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.

    This may include working with limited risk Hazard Group 3 material such as samples positive for, COVID-19, HIV or Hepatitis B.Disseminate and ensure compliance with study-specific risk management plans.

    Be responsible for maintaining and updating the laboratory Health and Safety policies as required.

    Be responsible for ensuring all staff using the laboratory have read and signed the appropriate policies and SOPs and completed the relevant lab training.

    Work in accordance with good clinical laboratory practices and local safety and quality initiatives.
    Oversee the removal of clinical waste.
    Notify management team of any changes required to waste management processes.
    Deal with spillage of samples/chemicals in a safe and appropriate manner when necessary.
    Biomedical Science degree, or equivalent knowledge, skills and experience
    Evidence of Continuing Professional Development (CPD)
    Recognised IATA training

    A minimum 3 years post-qualification work experience in a related field
    Previous experience of working in a research laboratory handling and preparing samples for research studies/clinical trials
    Experience of training others
    Experience of working within a quality system, including use of SOPs and understanding of safe and effective use of equipment
    Experience of contributing the development and implementation of laboratory working practices and Standard Operating Procedures (SOPs)

    Experience of temperature monitoring systems

    Proficient in sample preparation, processing, storage and shipping.

    Detailed knowledge of relevant guidelines and regulations pertaining to research and the handling, preparation and processing of research study/trial samples including:
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