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Job Reference Number:
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NBC/25/18
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Position:
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Scientific Officer – Quality Assurance (Part-time)
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Group/Department:
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Quality Assurance (QA)
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Salary:
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£25,500 - £29,000 per annum FTE (£12,750-£14,500 pro rata) dependent upon experience
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Duration:
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2 years fixed term (in the first instance)
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PARTICULARS OF APPOINTMENT
Ref: NBC/25/18
Job Title: Scientific Officer - Quality Assurance (Part-time)
- The Centre invites applications for the above post.
- Salary will be within the range of £25,500 - £29,000 per annum FTE (£12,750-
£14,500 pro rata) dependent upon experience.
- For applicants who require assistance with their application please contact the HR Department for further information on:
Tel: +44 (0)161 306 9752
Email: jobs@cruk.manchester.ac.uk
- The Centre will endeavour to contact shortlisted candidates promptly. However, there may be occasions where a high volume of applications are received, therefore an applicant’s patience is appreciated.
- As an equal opportunity employer, we welcome applicants from all sections of the community regardless of age, sex, gender (or gender identity), ethnicity, disability, nationality, religion or belief, sexual orientation, marital or transgender status. All appointments are made on merit.
- As our Scientific Officer you will be a visible presence within the Centre, providing professional and timely services within your role. This role is focused on being a visible and operational support to the Centre.
COPY OF THE ADVERTISEMENT
The Centre will actively foster a culture of inclusion and diversity and will seek to achieve true equality of opportunity for all members of its community.
Scientific Officer - Quality Assurance (Part-time)
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- Salary in the range of £25,500 - £29,000 per annum FTE (£12,750-£14,500 pro rata) dependent upon experience
- Job Ref: NBC/25/18
- Duration of post: 2 years fixed term (in the first instance)
- Part-time role - 0.5 Full Time Equivalent (17.5 hours per week)
About the role:
We are recruiting a motivated part time Scientific Officer – QA to join the Quality Assurance Team within the CRUK National Biomarker Centre (NBC) to contribute to our compliance efforts by assuring our clinical trial activities comply with relevant Good Clinical Practice (GCP) regulations and guidelines for Laboratories.
In this role, you will work alongside multidisciplinary laboratory and support teams and contribute to maintaining and assuring that our Quality Management System (QMS) and associated documents are fit for purpose, that non-conformances are addressed, all regulated documentation and associated records are up to date, and provide guidance in relevant regulations, standards, and procedures. You will have the opportunity to work closely with personnel at all levels of the organisation to assure our regulated GCP activities meet the required standards.
About you:
You should have experience in a QA or compliance role within a GxP regulated laboratory and knowledge of GCP regulations, internal audits, non-conformance (or deviation) and CAPA management. Ideally you will have experience with LIMS and QPulse. You should have a BSc (or equivalent) in Science or related subject or have equivalent relevant experience.
This role will suit a candidate with keen attention to detail and exceptional interpersonal skills, who is able to work collegiately to achieve a common goal.
Why choose Cancer Research UK National Biomarker Centre?
The Cancer Research UK National Biomarker Centre (https://cruknbc.org/) is a leading and highly specialised translational research centre within The University of Manchester (www.manchester.ac.uk), aligned with the Cancer Research UK Manchester Institute (www.cruk.manchester.ac.uk), and core-funded by Cancer Research UK (www.cancerresearchuk.org), the largest independent cancer research organisation in the world. In spring 2023 the Institute moved into the state-of-the-art Paterson Building, a £150 million flagship purpose-built biomedical research centre directly attached to The Christie NHS Foundation Trust in South Manchester (www.christie.nhs.uk), one of the largest cancer treatment centres in Europe. These factors combine to provide an exceptional environment in which to pursue basic, translational and clinical research programmes.
Our Centre discovers, develops, validates and qualifies biomarkers in clinical studies and trials that detect cancer earlier and predict and monitor therapy responses to support optimised treatment of patients with cancer. Our advanced research programmes, agnostic to cancer type, develop biomarkers in tissue and less invasive clinical samples such as blood (liquid biopsy) with sophisticated bioinformatic and artificial intelligence solutions for multi-modal laboratory and clinical biomarker data analysis and interpretation. As a bridge between discovery science and clinical research, we are highly collaborative across Manchester, nationally and internationally.
About the Quality Assurance (QA) Team
Please visit our website to view information about Quality Assurance (QA) Team:
https://cruknbc.org/
Disabilities and alternative formats
The University of Manchester is a disability confident Leader and is committed to supporting disabled people in recruitment, employment, and career development. We will make reasonable adjustments to enable applicants to
compete to the best of their ability wherever it is reasonable to do so. Therefore, if you have any additional support needs throughout the recruitment process or require documentation in alternative formats, please do not hesitate to contact the HR Department, for further information, on:
Tel: +44 (0)161 306 9752
Email: jobs@cruk.manchester.ac.uk
The Disability Confident scheme, accredited by the Department for Work and Pensions (DWP), helps employers recruit, retain and train great people. Disability Confident organisations play a leading role in changing attitudes about, and increasing understanding of, disability. There are three levels of the scheme with Leader being the highest.
CANCER RESEARCH UK NATIONAL BIOMARKER CENTRE JOB DESCRIPTION
JOB DETAILS
Job Title: Scientific Officer - Quality Assurance (Part-time)
Grade: MI2
Team: Quality Assurance (QA) Team
Division: Cancer Research UK National Biomarker Centre (NBC)
ORGANISATIONAL ARRANGEMENTS
Accountable to: 1. NBC Head of Quality Assurance
2. NBC Director
JOB PURPOSE
To strengthen the existing and expanding activities of the NBC QA team which are focused on:
- GCP compliance,
- ensuring that patient sample analysis is performed in accordance with the Clinical Trials Regulations,
- maintaining the highest level of achievable quality.
To support the efficient and effective day-to-day running and organisation of QA activities.
DUTIES AND RESPONSIBILITIES
Using a range of Quality Management System (QMS) procedures and after relevant training and discussion with the Head of QA, the post holder will be competent to carry out the 4 main duties and responsibilities as detailed below:
- Contributing fully to the day-to-day activities of the NBC QA Team
- Conducting document reviews on the behalf of QA
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- Performing project reviews and
activation within the Laboratory Information Management System (LIMS).
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- Conducting scheduled internal audits
- Supporting the completion of Non-Conformances (NCs) and Corrective and Preventative Actions (CAPA)
- Supporting the timely delivery of QA activities by participating in the assignment and monitoring of QA work requests
- Ensuring all QA documentation is completed and up to date
- Prioritise own workload and keep the Head of QA always informed of developments in the progress of projects
- Interacting with specialist teams and core NBC groups on all matters of GCP compliance
- Participating in the further development of the NBC Quality Management System (QMS)
- Identification of opportunities for harmonisation and/or efficiency improvements for controlled processes
- Reviewing Standard Operating Procedures (SOPs) and associated documentation, providing relevant feedback regarding compliance issues
- Writing new SOPs where required and associated documentation
- Providing training in relevant regulations, standards and procedures
- Providing specialist QA/Compliance advice and guidance to colleagues
- Shares knowledge of techniques and procedures for the benefit of others
- Maintaining an awareness of current regulatory requirements and developments
- Keeping abreast of current regulatory requirements and developments for GCP and communicating these to NBC project managers and analysts
- Attending relevant conferences and training courses
- Maintaining or working toward a professional quality related qualification/affiliation
- Other Duties and Responsibilities
- Supports preparations for external audits and regulatory inspections.
- Makes contributions to the overall success of Centre.
- Assists with maintaining laboratory health and safety requirements.
- Undertakes any other duties, as requested by the Head of QA and/or NBC Director.
STANDARDS OF PERFORMANCE
- Work efficiently, cost-effectively and in a flexible manner
- To meet objectives within pre-determined timescales
- Effective communications to be maintained with staff at all levels
- Strict adherence to QMS procedures, protocols and Institute policies
- To comply with Health & Safety requirements, including having an awareness of personal responsibilities to maintain a safe working environment
- To contribute to the University’s agenda for social responsibility, including sustainability
- To maintain confidentiality of information in line with data protection requirements and University policy
- Familiarise themselves with the University’s Equality and Diversity policies and to actively support these wherever possible
- Be a team player
- To strive to accomplish a high quality of work
PERSON SPECIFICATION
The person specification should set out the qualifications, experience, skills, knowledge, personal attributes, competencies and other requirements which the post holder requires to perform the job to a satisfactory level.
Job Title: Scientific Officer - Quality Assurance (Part-time)
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ESSENTIAL
The qualities without which a post holder could not be appointed
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DESIRABLE
Extra qualities which can be used to choose between candidates who meet all the essential criteria
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METHOD OF ASSESSMENT
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QUALIFICATIONS
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- BSc (or equivalent) in Science or related subject or (equivalent relevant experience)
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- MSc (or equivalent) in Science or related subject or (equivalent relevant experience)
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Presentation of Certificates and CV
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EXPERIENCE
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- Relevant QA or compliance experience working in a regulated academic research or industrial laboratory setting.
- Working to GxP standards
- Experience of internal audits, non-conformances and CAPA management
- Track record of delivering high quality work within agreed deadlines
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- Experience with LIMS
- Experience with Q-Pulse software or equivalent electronic QMS
- Experience in training staff
- Experience of working in a translational/clinical environment
- Experience of working to GCP, GLP or GCLP
standards
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Interview, CV and references
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SKILLS
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- Accurate, comprehensive record-keeping
- Strong attention to detail
- Excellent communication skills, written and verbal
- Effective organisational skills and good multi- tasking ability
- Ability to work under
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- Root cause analysis skills
- Presentation skills
- Ability to handle pressurised scenarios including MHRA inspection conditions
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Interview, CV and references
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SKILLS
Continued
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minimal supervision
- Problem solving capabilities
- Proficient at using computer software
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Interview, CV and references
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KNOWLEDGE
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- Familiar with basic computing software (e.g. MS office)
- Knowledge of GCP (Good Clinical Practice), GLP (Good Laboratory Practice), or GCLP (Good Clinical Laboratory Practice) requirements.
- Knowledge of audit and non-conformance management
- Knowledge of root cause analysis techniques
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- Working knowledge of “Health and Safety at Work” requirements
- A general knowledge of cancer and/or knowledge in the field of biological sciences
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Interview, CV and references
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OTHER
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- Self-motivated
- Meticulous
- Interactive
- Organised
- Ability to work to strict deadlines
- Ability to work well within a team framework as well as on an individual project
- Technically focused
- Willingness to learn and implement new practices
- Ability to maintain confidentiality
- To show commitment to equality and fairness and integrity in dealing with others
- To be willing to work across organisational
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- Membership of RQA or other relevant professional society
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Interview, application form and references
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OTHER
Continued
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boundaries
- To seek new knowledge and share ideas
- To be open and responsive to change and
innovation
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Interview, application form and references
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THE CITY OF MANCHESTER AND THE REGION
Manchester is one of the great European cities and the Cancer Research UK National Biomarker Centre is located a short distance from the city centre and is serviced by regular public transport to the city centre. The city’s architecture represents one of the high points of Victorian achievement. The modern city is a major centre of banking, commerce and manufacturing.
It is consistently ranked as the best liveable city in the UK by the Economist Intelligence Unit. In 2021, Manchester was ranked in the top 3 of the TimeOut World’s Best Cities list with the comment, “the friendliest city with the best community spirit and top-notch nightlife including its Gay Village and Northern Quarter in the heart of the city.” It has a highly cosmopolitan atmosphere, and its cultural life is internationally renowned.
Manchester offers extensive provision for research. Library facilities include the John Rylands University Library (the major library in the North West and the third largest in the country) and the Manchester Central Reference Library.
Housing is varied, plentiful and the price ranges can start moderately priced and are as varied as the requirements. Schooling ranges from world-famous private schools to excellent sixth-form colleges and comprehensives.
Manchester is well served by a major international airport, with direct scheduled flights to many destinations in Europe as
well as North America and Asia. Some of the most beautiful countryside in Europe is just short of an hour’s drive from the Centre in the Peak District National Park, while the Lake District and Snowdonia in Wales are also within easy reach.
Manchester Piccadilly railway station has
been refurbished and is served by inter-city and other train services – with a direct link to Manchester Airport. The network of Metrolink tram services offers an alternative mode of public transport from certain parts of the conurbation and includes connections near to the Centre.
There are three outstanding professional theatre companies, the halls of the Hallé and BBC Philharmonic orchestras, the Cornerhouse as well as other cinemas, and Europe’s fastest-growing Chinatown.
Amongst the developments enriching the area’s cultural life have been the opening of the Lowry Centre and Media City at Salford Quays; the opening of the Bridgewater Concert Hall; the refurbishment of the City Art Gallery; the opening of Urbis in the centre of Manchester and of the Imperial War Museum North, designed by Daniel Libeskind, in Trafford.
Trafford, specifically Old Trafford, is known internationally for sport, it is a venue for Test cricket and the home of Manchester United FC. The Commonwealth Games were held in Manchester in 2002 and were highly acclaimed. The Commonwealth Stadium became the home of Manchester City FC in 2003.
OUR BENEFITS PACKAGE
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Facilities and General Discounts
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We have a wide range of fantastic facilities for you including coffee shops, cafes, and restaurants in various buildings on Oxford Road, library, museum, art gallery, theatre (providing music and drama) and the world-famous radio telescope at Jodrell Bank. You can attend a varied programme of events at these, many of which are free to staff. Staff also have a plethora of discounts available to them on fitness, entertainment, restaurants, hotels, supermarkets, and online retailers.
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Health and Fitness
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We have a fantastic range of sports and fitness programmes across three of the best sports facilities in the city of Manchester. Each of our facilities provides something for everyone and are in convenient locations across Oxford Road, Fallowfield and all the way into the City Centre. Staff have a discounted membership to these facilities.
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Wellbeing
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The Centre is committed to supporting staff wellbeing and have a range of resources available. This includes a free 24/7 helpline through our Employee Assistance Programme which allows staff to talk in confidence to trained counsellors and advisers on areas like emotional, physical, and mental health.
The University’s counselling service offers confidential help with any personal issues affecting work, self-esteem, relationships, sexuality, mental health and general well-being. It is accessible to all staff and is part of a wider network of help and support; and can advise on where else to seek help and make referrals to NHS mental health services.
The University’s Occupational Health service provides confidential services to protect the health of staff and ensures that all health issues are effectively managed. Additionally, the Centre/Institute has wellbeing working groups and employee champions to support staff.
We offer a generous annual leave allowance of 32 days per year, (pro rata for part time staff) plus bank holidays for England. The Centre/Institute gifts an additional day’s leave on Christmas Eve.
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Travel
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The Centre is committed to reducing its environmental impact and actively supports and promotes travel by sustainable means. We work closely with The Christie NHS Foundation Hospital to have a green travel plan that aims to provide a package of measures that increase the travel options available to staff. These options include as a Cycle to Work Scheme and annual interest- free travel loans with Northern Rail, Stagecoach and Metrolink.
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Family Friendly Support
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If you have childcare responsibilities the Centre can provide you with a range of support to assist you in balancing your work and home life commitments. Information is available on the government’s Tax Free Childcare Scheme and The University’s Workplace Nursery Scheme. We also have a range of family friendly policies and staff have the right to request to work flexibly.
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Equality, Diversity, and Inclusion (EDI)
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The Centre is committed to creating an environment where diversity is celebrated and everyone is treated fairly, regardless of gender, gender identity, disability, ethnicity, religion or belief, sexual orientation, marital or transgender status, age, or nationality. The Institute/Centre has an EDI committee which provides leadership, drive and strategic direction on equality, diversity, and inclusion across all parts of the Institute/Centre. The committee will seek to promote cultural change and ensure that the EDI action plan is embedded across all functions of the Institute/ Centre.
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Personal Development
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Whether you are a research scientist, technical or operational staff, you will receive excellent on the job training and an opportunity to share skills experience and expertise in a collaborative environment. The Centre has a range of training available for support and professional development.
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Disability
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The Centre/Institute is committed to providing a positive working environment free from discrimination, harassment, or victimisation due to a disability where all staff are treated with respect and dignity. The Centre/Institute has access to a Disability Advisory and Support Service (DASS) which has a dedicated disability adviser for staff to provide advice, guidance and support about a range of practical adjustments in the workplace.
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Pension
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We have two generous pension schemes to provide benefits for you and your family. For more details, please contact the HR department.
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ADDITIONAL RECRUITMENT AND SELECTION PARTICULARS
Shortlisted Candidates:
- We will reimburse reasonable travel expenses. You need to retain all your receipts, as you will need to submit these with your expense claim form. This form will be given to you when you attend your interview.
- If candidates require accommodation the Centre can arrange this for you. Please notify the HR Department as soon as possible so that this can be arranged on:
Tel: +44 (0)161 306 9752
Email: jobs@cruk.manchester.ac.uk.
Please note that reimbursement for accommodation may not apply.
- If candidates have any additional support needs to enable them to attend an interview, they will be able to request/discuss this with the HR department when arranging the interview.
- Shortlisted candidates may be expected to complete a presentation as part of the selection process. Information regarding the duration and title of the presentation will be provided in the invitation to interview correspondence. We supply both laptop and projector for presentations.
- All dates and times stated in correspondence from the Centre/Institute refer to BST (British Summer Time).
- Candidates need to bring along their passport to interview, a copy of which will be taken for our records, when you visit the Centre/Institute. If candidates have difficulty in producing their passport, please contact the HR Department prior to the interview on:
Tel: +44 (0)161 306 9752
Email: jobs@cruk.manchester.ac.uk
- MS Teams or Zoom interview with or without presentation:
Instances may arise where we propose to hold an online interview as a (first stage) selection process. If this is the preferred method of interview, this will be stated on your invite to interview email. You will be provided with a link and password to attend the interview at a specified time on a specified date. This
link will redirect you to your MS
Teams/Zoom interview. 24 hours prior to interview we will require:
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along with a scanned copy of passport for ID purposes
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- Where applicable, a copy of your presentation emailed to:
Please note:
You do not have to have a Zoom account to attend a Zoom interview. You will be prompted to download the software, once you have clicked on the link that you have been provided. You do, however, need to have a working microphone and camera connected to your electronic device, for this interview to go ahead.
The criteria will be consistent with all other candidates.
STANDARD CRUK MANCHESTER INSTITUTE TERMS AND CONDITIONS
The following is a basic summary of the standard terms and conditions applicable to the post you have applied for:
- The post of Scientific Officer - Quality Assurance (Part-time), is on a Cancer Research UK pay scale. It’s on an MI2 grade with a salary range of £25,500 -
£29,000 per annum FTE (£12,750-£14,500 pro rata) dependent upon experience.
- Your employment will be with The University of Manchester appointed under the Cancer Research UK Manchester Institute terms and conditions.
- Salary is paid monthly on the penultimate last working day of the month.
- There are 32 days holiday per year full-time equivalent plus Bank Holidays for England. This will be calculated on a pro rata basis depending on your working pattern.
- Duration of contract is: 2 years fixed term (in the first instance)
- Working hours are 17.5 hours per week.
- There is a probationary period attached to this post of 6 months. It’s standard for many organisations now and consists of two 3-monthly reviews with your line manager.
- You are eligible to join USS (https://www.uss.co.uk/) pension scheme.
- Any offer made by the Cancer Research UK National Biomarker Centre would require the successful candidate to undergo a medical clearance. This is arranged with Occupational Health department at The University of Manchester prior to starting employment and consists of a basic medical. This is to address and gain clearance for any potential hazards identified for the role on offer.
- Offer is subject to receipt of satisfactory references and proof of your highest qualification.
- Offer is subject to documented evidence of your right to work in the UK under the Home Office UK Border Agency Regulations.
- Please note this role is not eligible for sponsorship under the Skilled Worker route of the Points Based System. Candidates will need to be able to demonstrate their right to work in the UK in order to be eligible to take up the post.
- The successful candidate is required to complete a Rehabilitation of Offenders/Criminal Records declaration form at the offer stage of the process. Please note a criminal record will not necessarily be a bar to obtaining a
position.
- The Centre is promoting a green travel plan and there are staff benefits promoting this including a cycle to work scheme and the use of public transport. There are strong links to bus routes and trains to the Centre’s location. More information about this can be found on our ‘Our Benefits Package’ page or by contacting the HR Department.
Please note there are car parking restrictions imposed around these sites.