CRF Laboratory Technician

The Christie NHS Foundation Trust; Manchester; On-site; GBP 21,000 - 28,000; Full time

Job summary

The Christie NHS Foundation Trust in Manchester invites applications for a full-time CRF Laboratory Technician role. You will perform pre-analytical preparation of biological samples and support trial management, with a balance of hands-on work and documentation in a fast-paced environment.

You will handle PBMC isolation and sample processing to SOPs, maintain source documents, and ensure regulatory compliance with GDPR, HTA/MHRA, and GLP/GCP while contributing to a collaborative clinical

Qualifications

• Evidence of core skills in literacy, numeracy, ICT and English.
• Suitable qualifications or experience in a Scientific discipline e.g. ECDL.
• A level or equivalent in science NVQ level 3 or apprenticeship.

Responsibilities

• Maintain high level communication with Trust, CRF staff and external sponsor companies.
• Accurately represent the Clinical Research Facility Laboratory at events and with potential partners.
• Quality control of all biological samples and documentation for sample processing.
• Notify senior staff of non-compliance issues and critical incidents.
• Adhere to HTA, MHRA, GDPR guidelines and ensure patient anonymity.
• Maintain Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).
• Assist in trial setup and capacity questions.
• Assist in allocation of space and stock management.

Skills

Pre-analytical procedures

PBMC isolation

Sample handling

Communication skills

Attention to detail

Education

Scientific discipline qualification or experience

A level or equivalent in science

Tools

Microsoft Excel

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.

Main duties of the job

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.

Working for our organisation

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.

Detailed job description and main responsibilities

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.

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 exclusive to:

a. Whole blood, serum, and plasma,

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

c. Preparation of platelet-rich plasma (PRP),

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

e. Weighing, and stabilising urines

f. Identification of stool samples

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:

d. Precision pipettes,

e. Weighing scales,

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.

Person specification

Qualifications

• Evidence of core skills in literacy, numeracy, ICT and English Language
• Suitable qualifications or experience in a Scientific discipline e.g. ECDL
• A level or equivalent in science NVQ level 3 or apprenticeship

Experience

• Previous experience of working in a laboratory

Skills

• Excellent communication skills, both verbal and written
• Effective team working
• Ability to work methodically and accurately, paying attention to detail
• Willingness to learn and ability to retain information
• Ability to use initiative
• Ability to multi-task

Knowledge

• Knowledge of Health and Safety legislation
• Understanding of the Data Protection Act
• Knowledge of Human Tissue Act and Medicines and Healthcare Products Regulatory Agency regulations

Values

• Ability to demonstrate the organisational values and behaviours

Other

• Effective and enthusiastic team member
• Well presented
• Able to practice flexible working hours

The closing date for this post may be extended if there are insufficient applicants or brought forward if there is a high volume of applicants.

Sponsorship Information - We are an approved sponsoring organisation. Applications will be considered from applicants requiring sponsorship alongside all other applications. Please be aware, not all roles are eligible for sponsorship. You can review the list of eligible role and requirements on thegovernment website.

Pre-Employment Checks - To confirm your suitability for the role, we will carry out pre-employment checks in line withNHS Employment Check Standards . These include:

• Identity verification
• Right to work check
• Disclosure and barring service (DBS)/Criminal record check (dependent on role, payment of this will be the applicants responsibility)
• Professional registration and/or qualification check
• Occupational health assessment
• Employment history and reference validation

All applicants external to The Christie NHS Foundation Trust will be required to provide theirHMRC employment history to cover the most recent three years employment. This information will used to validate employment history andreferences.

If you require sponsorship, we will assess your eligibility based on currentgovernment guidance. If the role is not eligible and you cannot demonstrate your right to work, your conditional offer may be withdrawn.

If You're Offered the Role - you will be agreeing to The Christie NHS Foundation Trust transferring the information contained in this application to its preferred applicant management system. If you are offered a job information will also be transferred into the national NHS Electronic Staff Records system. Please note, all communication regarding your application will be made via email, please ensure you check your junk/spam folders as emails are sometimes filtered there.

The Inter-Authority Transfer (IAT) process is a critical and beneficial component of ESR and will form part of the recruitment process. In the event that you are successful following interview your previous NHS employment data, if applicable will be transferred from your current / most recent employer.

Sponsorship Information - We are an approved sponsoring organisation. Applications will be considered from applicants requiring sponsorship alongside all other applications. Please be aware, not all roles are eligible for sponsorship. You can review the list of eligible role and requirements on thegovernment website.

No Smoking Policy - You should be aware the Trust operates a No Smoking Policy and therefore employees are not permitted to smoke at work.

Additional Information - We want to ensure that everyone who works at the Christie or uses our services is welcomed, valued and treated with dignity and respect.The Christie values diversity and is committed to ensuring equal opportunities for all and fair representation across the organisation at all levels. In support of these commitments, we particularly welcome applications from Black, Asian and other ethnic minority people and people with disabilities for this post. Appointment will be only on merit.

We are committed to creating a balanced and diverse workforce. As such we welcome and encourage applications from people of all backgrounds. Together we will foster inclusion and tackle inequity and health inequalities in cancer care.

As users of the disability confident scheme, we guarantee to interview all disabled applicants who meet the minimum criteria for the vacancy.

The Christie NHS Foundation Trust is committed to the highest standards of ethical conduct and integrity in all our activities. We have a zero-tolerance approach to modern slavery in any of its forms, including slavery, servitude, forced or compulsory labour, and human trafficking. We are fully committed to acting ethically and with transparency in all our business dealings and relationships, and to implementing and enforcing effective systems and controls to ensure modern slavery is not taking place anywhere in our organisation or supply chains.