CRF Laboratory Technician

The Christie NHS Foundation Trust; Manchester; On-site; GBP 24,000 - 32,000; Full time

Job summary

The Christie NHS Foundation Trust invites applications for a full-time CRF Laboratory Technician based in Manchester. The role combines hands-on pre-analytical processing of biological samples and essential administrative tasks within the Clinical Research Facility Laboratory, supporting translational biomarker studies and multi-site trials.

You will follow SOPs, maintain source documents, ensure sample integrity, handle hazardous materials safely, and support trial set-up and calibration of

Qualifications

• Computer literacy including Microsoft Outlook, Excel and Word.
• Experience with internal electronic resources such as CWP, R-PEAK and QPulse to process samples.

Responsibilities

• Follow technical protocols for pre-analytical preparation of biological samples.
• Complete and maintain source documents.
• Prioritise and manage workflow in a fast, changeable environment.
• Identify and troubleshoot errors in the trial process.
• Maintain quality control of samples and ensure proper documentation.

Tools

Outlook

Excel

Word

CWP

R-PEAK

QPulse

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 a pre-analytical lab only and does 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., 3. 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.
• 4. Notify a senior member of staff or management of all non-compliance issues and critical incidents encountered in the performance of duties.
• 5. Adhere to all guidelines and legislation set out by regulatory organisations such as the Human Tissue Authority (HTA), Medicine Healthcare Products Regulatory Agency (MHRA).
• 6. Ensure patient anonymity of all biological samples to adhere to the General Data Protection Regulations (GDPR)
• 7. 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.
• 8. Maintain Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) at all times, in accordance with current legislation.
• 9. Knowledge of departmental, trust and trial specific Standard Operating Procedures (SOPs). Assistance in the development of departmental SOPs and documentation will also be required.
• 10. Knowledge of all clinical protocols, provided by external sponsors for clinical trials which require sample handling.
• 11. To identify deliveries of stock, identify what is required in the Laboratory, and assist in allocation of shelf space for research-specific deliveries.
• 12. 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.
• 13. To assist the Senior Laboratory Technician in trial set-up, and capacity and capability queries.

Sample handling and processing

1. To receive, process, log, store and ship biological samples in accordance with SOPs.
2. Preparation of samples for analysis according to Standard Operating Procedures both Trust and Trial Specific, including but not exclusive to:
   1. a. Whole blood, serum, and plasma,
   2. b. Isolation of peripheral blood mononuclear cells (PBMCs), and plasmacytoid dendritic cells (PDc)
   3. c. Preparation of platelet-rich plasma (PRP),
   4. d. Washing and fixing, snap-freezing and embedding tumour biopsies,
   5. e. Weighing, and stabilising urines
   6. f. Identification of stool samples
   7. g. Manual differential slide preparations from whole blood, and bone marrow aspirates.
3. Ensure the quality control for bulk stocks including solvents for decontamination, hazardous chemicals, reagents, buffers, dry ice and liquid nitrogen.
4. Ensuring compliance with Trust and departmental health and safety procedures when handling hazardous materials and ensuring untrained staff are not exposed to these materials.
5. Ensuring all trial specific laboratory materials supplied by external companies are adequate, to complete all processes as outlined in the clinical protocol.

Equipment Maintenance and Calibration

1. Responsible for ensuring that all equipment is cleaned, decontaminated calibrated and maintained as necessary. Including but not exclusive to:
   1. a. Centrifuges/micro centrifuges,
   2. b. Class II Biohazard Safety Cabinets
   3. c. Vortex,
   4. d. Precision pipettes,
   5. e. Weighing scales,
   6. f. Fridges/Freezers.
2. Ensure that all of the above is documented appropriate for audit purposes.
3. Assist in allocation and management of freezer space.
4. To perform general laboratory duties, such as cleaning area used for sample preparation to ensure the integrity of all samples processed.

Documentation

1. Fill out departmental documentation to record trial activity daily for all biological samples that pass through the laboratory.
2. Fill out departmental documentation to record trial activity daily for all shipments that leave the laboratory to external sites.
3. Ensuring that these documents are legible, clear and concise for archiving to the site file upon trial closure.
4. 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.
5. To perform general clerical duties, such as archiving, filing and photocopying.

I.T Skills

1. Computer literacy is necessary using Microsoft packages such as Outlook, Excel, and Word.
2. Use of internal electronic resources (including Using CWP, R-PEAK, QPulse etc.) to process and track all samples processed in the Clinical Research Facility Laboratory.

Training and Education

1. Undergo all mandatory training outlined by the Trust, including any updates necessary.
2. 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.
3. Participates in the Trust's annual appraisal procedure, maintaining competence levels within the Department and assists in own personal and professional development
4. Undertake all necessary training provided by trial sponsor companies and external scientist to ensure improvement of this service.
5. Take a supervisory role in helping to train new members of staff to use the Clinical Research Facility Laboratory, including students on work experience.
6. Maintain up to date knowledge of necessary legislation and regulations to help prepare for external audits.

Communication and Professional Responsibilities

1. 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.
2. To be able to accurately represent the Clinical Research Facility (CRF) Laboratory:
   • a. At open days/ Patient and Public Involvement and Engagement (PPIE) events,
   • b. To potential companies looking to work with the CRF.

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 is one of Europe's leading cancer centres, looking after more than 64,000 patients a year. We are based in Manchester and serve a population of 3.2 million across Greater Manchester & Cheshire, but as a national specialist around 25% patients are referred to us from other parts of the country.

We are the largest radiotherapy provider in the NHS with one in 20 treatments delivered at The Christie. We have up to 15 linear accelerators operating across our network of sites. We operate the largest chemotherapy unit in the UK on our main site and treatments are also provided at 13 other networked sites, and in patients homes. And as a specialist tertiary surgical centre, we focus on rare cancers, complex procedures, and multidisciplinary approaches to cancer surgery, specialising in colorectal, peritoneal, gynaecological, urological and plastic surgery.

We are also an international leader in research, with world first breakthroughs for over 100 years. We have been named by the UK's National Institute for Health Research (NIHR), as one of the best hospitals providing opportunities for patients to participate in clinical research studies, with more than 800 studies open at any time, caring for over 3,000 patients.