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Background

The post will be based within the Institute of Head and Neck Studies and Education (InHANSE) which is part of the Institute of Cancer and Genomic Sciences (ICGS). InHANSE forms a research group of 10 members that work on various aspects of head and neck cancer research activities under the direction of Professor Hisham Mehanna. It is a multidisciplinary team and is one of the leading research groups internationally in head and neck cancer.

Its research portfolio includes molecular and translational research (such as biomarker discovery and development), multinational, multi-centre clinical trials, and international collaborations. As a member of the InHANSE team, the post holder will help coordinate research projects involving large datasets, oversee human sample collections resulting from clinical trials, perform technical and/or scientific investigations, and assist with other research duties as needed.

Summary of Role

The post holder will provide a high level of expertise in a range of technical skills and scientific administrative/management tasks to support the research activities within InHANSE. This includes curating and maintaining large databases and ensuring that research involving clinical trial sample collections is compliant within the current regulatory clinical trial framework. Critically, the post holder is responsible for working with both clinical samples and clinical data, and ensuring compliance to current legislation and regulations, including knowledge of Ethics, GDPR, MHRA, HTA, GCP and GCP in Laboratory standards.

The technical aspects of the post may include tissue culture (establishment and expansion of primary cell culture and maintenance of cell lines), functional assays to assess drug efficacy (Alamar Blue, clonogenic and Annexin V assays), xeonograft animal studies, immunohistochemistry (sectioning and staining of samples) and molecular biology techniques (DNA/RNA extraction, library preparation for DNA/RNA sequencing), flow cytometry, isolation of circulating tumour cells. The post holder will also be involved in data collection and analyses of multiple projects.

The post will include oversight of trial sample collections (blood, tissue and oral fluid) and clinical datasets held by InHANSE for its clinical trials and research studies. The post holder will be expected to manage and organise research data including curating and maintaining large databases in a GDPR compliant way. He or she will also be expected to implement and ensure compliance with GCP/GCLP when receiving, processing and storing clinical samples. In addition, he or she will be expected to liaise with clinical trials teams, participating centres, and internal and external collaborators, and to provide fortnightly progress updates to the Research Team Leader and/or Chief Investigator.

Experience in maintaining databases and processing of human samples and working under Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) is essential. The postholder will be expected to work in-person on campus 5 days a week.

Main Duties / Responsibilities

Head and Neck Cancer Trials

The role holder will be required to:

• Manage sample collections and clinical datasets held by InHANSE for its clinical trials and research studies, implementing and ensuring compliance with GCP/GCLP and GDPR
• Administer appropriate protocols/standard operating procedures (SOPs)/Data Management Plans
• Ensure appropriate collection, processing, and storage of clinical samples and datasets and/or other research materials
• Co-ordinate the effective collection of important trial samples from UK trial sites by establishing close working ties with the trial centres
• Maintain necessary internal records and perform regular quality checks, including vertical and horizontal audits, of sample collections and datasets
• Liaise and maintain records for samples and datasets
• Monitor the availability and appropriate use of samples and datasets across various research studies for various projects
• Keep accurate records of all experiments, results evaluations and summaries
• Develop or adapt techniques, models and methods, as required
• Contribute to and present key points of research outputs to a wide audience, as required
• Provide expert technical guidance, as required, to staff and students within the research group

Laboratory Based Research

The role holder will also provide a high level of expertise in a range of technical skills to support the research within InHANSE. The role holder will have the ability to develop, optimise, validate and implement techniques and analyse research data as appropriate. These techniques may include, but will not be limited to:

• Culture and use of primary cells and cell lines in vitro
• Liaise effectively with clinical staff to ensure the timely collection and transfer of primary tissue to InHANSE research labs
• Isolation and enrichment of cell subsets from primary tissue
• Perform in vitro experiments such as alamar blue and clonogenic assays
• Multi-colour flow cytometry including part analysis of the data
• Assist with in vivo experiments including xenograft models
• Protein, DNA and RNA extraction
• Western blotting techniques
• PCR techniques
• Preparation of DNA/RNA libraries for sequencing
• Sectioning FFPE tissue
• Immunohistochemistry
• Processing and storage of clinical trial samples (blood, tissue and oral fluid)

Management of Laboratories

In addition, the post holder will contribute to general administrative tasks relevant to their role. This includes:

• Maintaining stocks of consumables, creating purchase order requisitions and using a web-based ordering system
• Ensuring that the facilities are maintained in a clean, functional and safe condition, reporting any problems through the appropriate channels
• Dealing with/referring as appropriate any problems with equipment or services
• Ensuring all relevant group members comply with all basic health & safety policies
• Reporting any breaches or non-compliance with H&S procedures to the technology hub manager or college safety adviser
• Upholding the correct waste disposal stream as governed by college and local policy for laboratory, recycled and general waste
• Adopt a proactive attitude to assisting with and implementing carbon reduction and energy saving measures
• Any other duties commensurate with the grade and skill base of the role holder as directed by the line manager

Person Specification

• Degree or equivalent in relevant subject area
• Practical experience of applying the relevant skills and techniques
• Experience in primary cell and tissue culture
• Experience dealing with patient samples
• Experience working with datasets and maintaining databases
• Knowledge of the Animals Scientific Procedures Act (1986)
• Practical experience and certified formal training of Good Clinical Practice and Good Clinical Laboratory Practice
• Knowledge of the Human Tissue Act (2004)
• Ability to analyse information and communicate effectively
• Attend and contribute to team meetings
• Help prepare regular reports to complete analyses
• Ability to access and organise resources successfully
• Knowledge of safe working practices
• Work to agreed specifications, time, and quality standards
• Ability to deal with problems that may affect the achievement of research objectives and deadlines and the ability to suggest solutions in their own area, whilst having regard to the local and wider interests
• Proven ability to organise and manage own work load and demonstrate flexibility in terms of work practices/requirements
• Undertake those management/administration tasks that are related directly to the delivery of the research
• Positive service attitude and shows courtesy in dealing with others
• Proven ability to work independently but function as part of a team
• Knowledge of current relevant health & safety policies
• Proficiency in commonly used software packages and in-depth knowledge of analysis software
• Knowledge of the protected characteristics of the Equality Act 2010, and how to actively ensure in day to day activity in own area that those with protected characteristics are treated equally and fairly.