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Job description

The CRF Laboratory performs pre-analytical procedures on an array of biological samples for approximately 100 clinical trial visits per week, working on translational biomarker studies, the newest therapeutic agent trials, and existing later-phase clinical trials. These samples are subsequently stored, then shipped to central laboratories around the world. As part of the Good Clinical Practice (GCP) guidelines that underpin clinical trials worldwide, it is also vital that every step of this process is recorded and tracked. As a result of these requirements, the CRF Laboratory is central to clinical nursing staff on the CRF and in research, non-clinical research support staff, and external pharmaceutical companies.

The CRF Laboratory is apre-analytical labonly anddoes not undertake blood tests or handle blood results. There are no Biomedical Scientists, and no scope for IBMS Portfolio work.

The post is a full-time (37.5 hours per week), permanent position. The job is fast-paced and varied, with a balance of hands-on technical work and administrative work, and represents a great opportunity to build-on and use existing practical laboratory experience, and gain wider experience of how clinical trials are set-up and operate.

The main roles of the CRF Laboratory Technician are:

• Following technical protocols to undertake pre-analytical preparation of biological samples (i.e. centrifugation and pipetting, PBMC isolation).
• Completing and maintaining crucial source documents alongside the practical undertaking.
• Prioritising and managing workflow in a fast, changeable environment.
• Identifying and troubleshooting any errors in this trial process.
• Providing support and advice to research staff where required.

This role would suit a candidate with good technical ability, good customer service/communication skills, a sharp eye for detail, and the ability to multi-task and work under pressure.

The Christie NHS Foundation Trust serves a population of 3.2 million across Greater Manchester and Cheshire, and treats more than 44,000 patients a year. It is the largest single site cancer hospital in Europe and rated outstanding by the CQC. At The Christie, Clinical Research is embedded throughout our organisation with approximately 20% of patients taking part in clinical trials. The Christie currently has over 550 active clinical trials with a high proportion being early phase and first in human trials.

It is also home to one of 5 National Institute for Research and Care Research (NIHR) Clinical Research Facilities (CRF) in Manchester. The Facility provides a high-quality clinical environment to conduct translational, experimental cancer research studies, and the CRF Laboratory is a key part of the study process. The CRF Laboratory at the Christie is a small team, consisting of a Senior Laboratory Technician, 2x Associate Senior Lab Technicians, and 2x CRF Laboratory Technicians, which work closely together on a day-to-day basis, but also work closely with the CRF nursing team, and the wider R&I division.

DUTIES AND RESPONSIBILITIES

Communication and Professional Responsibilities

Maintain high level communication skills, to work with a wide range of staff from the Trust, the Cancer Research UK Manchester Institute and staff from external sponsor companies.

To be able to accurately represent the Clinical Research Facility (CRF) Laboratory:

At open days/ Patient and Public Involvement and Engagement (PPIE) events,

To potential companies looking to work with the CRF.

Quality control of all biological samples that are received into the Clinical Research Facility Laboratory. That all samples contain all necessary information required for sample processing.

Notify a senior member of staff or management of all non-compliance issues and critical incidents encountered in the performance of duties.

Adhere to all guidelines and legisation set out by regulatory organisations such as the Human Tissue Authority (HTA), Medicine Healthcare Products Regulatory Agency (MHRA).

Ensure patient anonymity of all biological samples to adhere to the General Data Protection Regulations (GDPR)

Maintain quality control over all samples shipped on dry ice, refrigerated, or ambient both domestically and internationally, by following International Air Transport Association (IATA) regulations.

Maintain Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) at all times, in accordance with current legislation.

Knowledge of departmental, trust and trial specific Standard Operating Procedures (SOPs). Assistance in the development of departmental SOPs and documentation will also be required.

Knowledge of all clinical protocols, provided by external sponsors for clinical trials which require sample handling.

To identify deliveries of stock, identify what is required in the Laboratory, and assist in allocation of shelf space for research-specific deliveries.

To further assist in the allocation of space, by assisting teams in discarding out-of-date/unused stock, as per local and trust specific waste management polices.

To assist the Senior Laboratory Technician in trial set-up, and capacity and capability queries.

Sample handling and processing

To recieve, process, log, store and ship biological samples in accordance with SOPs.

Preparation of samples for analysis according to Standard Operating Procedures both Trust and Trial Specific, including but not exclusive to:

Whole blood, serum, and plasma,

Isolation of peripheral blood mononuclear cells (PBMCs), and plasmacytoid dendritic cells (PDc)

Preparation of platelet-rich plasma (PRP),

Washing and fixing, snap-freezing and embedding tumour biopsies,

Weighing, and stabilising urines

Identification of stool samples

Manual differential slide preparations from whole blood, and bone marrow aspirates.

Ensure the quality control for bulk stocks including solvents for decomtamination, hazardous chemicals, reagents, buffers, dry ice and liquid nitrogen.

Ensuring compliance with Trust and departmental health and safety procedures when handling hazardous materials and ensuring untrained staff are not exposed to these materials.

Ensuring all trial specific laboratory materials supplied by external companies are adaquate, to complete all processes as outlined in the clinical protocol.

Equipment Maintenance and Calibration

Responsible for ensuring that all equipment is cleaned, decontaminated calibrated and maintained as necessary. Including but not exclusive to:

Centrifuges/micro centrifuges,

Class II Biohazard Safety Cabinets

Vortex,

Precision pipettes,

Weighing scales,

Fridges/Freezers.

Ensure that all of the above is documented appropriate for audit purposes.

Assist in allocation and management of freezer space.

To perform general laboratory duties, such as cleaning area used for sample preparation to ensure the integrity of all samples processed.

Documentation

Fill out departmental documentation to record trial activity daily for all biological samples that pass through the laboratory.

Fill out departmental documentation to record trial activity daily for all shipments that leave the laboratory to external sites.

Ensuring that these documents are legible, clear and concise for archiving to the site file upon trial closure.

Ensuring quality control for the completion of departmental documentation including but not exclusive to equipment decontamination, temperature recordings and samples logs both electronic and paper.

To perform general clerical duties, such as archiving, filing and photocopying.

I.T Skills

Computer literacy is necessary using microsoft packages such as Outlook, Excel, and Word.

Use of internal electronic resources to track all samples processed in the Clinical Research Facility Laboratory.

Training and Education

Undergo all mandatory training outlined by the Trust, including any updates necessary.

Attend all training agreed during the Personal Development Review, both internally and externally as agreed with line management, to maintain a high level of competency.

Participates in the Trust’s annual appraisal procedure, maintaining competence levels within the Department and assists in own personal and professional development

Undertake all necessary training provided by trial sponsor companies and external scientist to ensure improvement of this service.

Take a supervisory role in helping to train new members of staff to use the Clinical Research Facility Laboratory, including students on work experience.

Maintain up to date knowledge of necessary legislation and regulations to help prepare for external audits.