Main Purpose of the Job

The Microbiome and Health Human Studies Lead plays a central role in advancing the Quadram Institute’s mission to deliver healthier lives through innovation in gut health, microbiology, and food. This position is responsible for overseeing the design, implementation, and management of human studies focused on the gut microbiome, ensuring their delivery to the highest ethical and regulatory standards.

Reporting directly to the Head of Human Studies, the role requires a proactive and organised individual with a deep understanding of human research processes, strong leadership skills, and the ability to navigate complex regulatory landscapes.

This role will work in collaboration with the Food and Health Human Studies Lead to deliver a diverse portfolio of research studies, supported by a dedicated team of Human Studies Facilitators. The post holder will provide direction and management to these facilitators, fostering their professional growth and ensuring they have the resources and support necessary to effectively deliver human studies.

The Microbiome and Health Human Studies Lead will work closely with the Human Research Governance Lead to ensure all studies comply with ethical and regulatory requirements. This includes maintaining high standards of governance and integrity in research involving human participants and any relevant human tissue.

This is a unique opportunity to contribute to world-leading microbiome research while shaping the future of human studies at the Quadram Institute.

Key Relationships

Success in this role requires building and maintaining relationships with key stakeholders, including:
•    Human Studies Team members
•    QIB FMH ISP Project and Programme Managers
•    QIB FMH ISP leads
•    QIB FMH ISP Group Leaders and Researchers
•    NIHR Norfolk Clinical Research Facility Team
•    NHS Research and Development Teams
•    NRP Biorepository Team
•    NNUH Clinical Teams
•    Other NHS sites (primary and secondary care)
 

Main Activities & Responsibilities

Percentage

Responsible for the planning, initiation, oversight and management for assigned human studies and projects involving the use of human tissue samples, ensuring ethical, regulatory and local policy compliance 

20

Planning, scheduling and tracking of project timelines, milestones and deliverables including maintenance of reporting systems and preparation of progress reports for internal and external bodies/committees to ensure safe delivery of studies on time 

20

Ensuring data management and maintenance of the Trial Master File for assigned projects ensuring compliance with Good Clinical Practice and GDPR

10

Promotes a culture advocating the adherence to highest standards and ethical integrity, always ensuring human subject protection and reliability of trial results 

5

Supports inspection readiness for internal/external audits as required ensuring implementation of corrective actions within specified timelines 

5

Training and mentoring staff and students of the Food, Microbiome and Health Programme, as needed to support Human Study delivery at the Quadram Institute 

5

Contributing to associated publications stemming from studies (methods, ethics information, etc.) 

5

Responsible for providing supervisory/leadership role of other team members (including some line management) 

5

Responsible for creating and maintaining effective working relationships and communication streams between stakeholders both internal and external to QIB 

5

Managing quality and continuous improvement of human research delivered by the Food, Microbiome and Health Programme

5

Undertaking horizon scanning activities to mitigate any future potential risks to the effective delivery of the projects, proposing and implementing corrective actions where appropriate 

5

Assist in the conception and design of human studies and projects involving human tissue samples in collaboration with researchers and support teams at the Quadram Institute

5

Drafting, revising and submitting ethics applications/amendments for assigned studies 

5

As agreed with the line manager, any other duties commensurate with the nature of the post, for example, contributing to the work of Institute committees.

Education & Qualifications

Requirement

Importance

BSc in a relevant discipline

Essential

Current certification in Good Clinical Practice (GCP) training

Essential

PhD in a relevant discipline or equivalent level of experience

Desirable

Project management training

Desirable

Formal Management and Leadership training

Desirable

Specialist Knowledge & Skills

Requirement

Importance

Significant experience of managing research studies involving recruitment of human participants or human tissue (public health, industry and/or academic)

Essential

Understanding and experience of clinical microbiome-based studies

Essential

Strong knowledge of ICH-Good Clinical Practice, the Human Tissue Act, and GDPR/data protection legislation

Essential

Proven track record of delivery of projects/ programmes of work to time and budget

Essential

Previous experience of managing people/teams

Essential

Skills in data management using Laboratory Information Management Systems/ Clinical trial management software

Desirable

Publications and other relevant outputs

Desirable

Ability to design and implement experiments to investigate microbiome-related hypotheses.

Desirable

Understanding of the interactions between microbiomes and their hosts, including the impact on health

Desirable

Relevant Experience

Requirement

Importance

Knowledge of research ethics and preparing/amending applications for the permission and approval for health research using IRAS

Essential

Experience of writing reports for regulatory bodies, funders, ethics committees and research participants

Essential

Specialist knowledge of laboratory based activities for microbiology and microbiome studies and associated Health and Safety implications

Essential

Experience of cross-organisational working (with Industry, NHS and academic partners)

Essential

Experience of managing/mentoring/training of junior staff/researchers

Essential

Experience of collecting, handling, and processing biological samples for microbiome analysis

Desirable

Experience of managing regulated research studies (CTIMP)

Desirable

Experience in registering study protocols in publicly available databases

Desirable

Proven relevant experience in undertaking research in the NHS, public health or HEI setting

Desirable

Experience of working in a Clinical Research Facility

Desirable

Experience of working in a research facility licensed by the Human Tissue Authority

Desirable

Interpersonal & Communication Skills

Requirement

Importance

Excellent communication skills, both written and verbal

Essential

Reliable and conscientious

Essential

Excellent interpersonal skills, with the ability to work well as part of a team

Essential

Ability to follow instructions/Standard Operating Procedures

Essential

Additional Requirements

Requirement

Importance

Attention to detail

Essential

Promotes equality and values diversity

Essential

Strong IT skills, including use of Microsoft Windows applications, email and the internet

Essential

Excellent organisational and time management skills

Essential

Able to work on own initiative and with minimal supervision

Essential

Willingness to participate in public engagement activities to promote human studies

Essential

Willingness to embrace the expected values and behaviours of all staff at the Institute, ensuring it is a great place to work

Essential

Willingness to work outside of normal working hours as and when required

Essential

Quadram Institute Bioscience

The Quadram Institute is at the forefront of a new interface between food science, gut biology and health, developing solutions to worldwide challenges in food-related disease and human health.

We are engaged in fundamental and translational food and health research, alongside clinical studies, endoscopy and industry, working together to become a leading international hub for food and health research, combining scientific excellence and clinical expertise, delivering impacts on patient care and accelerating innovation.

The Quadram Institute is a diverse and multicultural scientific community. We thrive on our international and European links, appointing staff from across the world. Any candidate who would like further information on current or anticipated immigration requirements can contact the HR Team on +44 (0)1603 450888 or nbi.recruitment@nbi.ac.uk.

For more information about working at Quadram Institute Bioscience, please click here.

Department

Food, Microbiome and Health

Group Details

Our Food, Microbiome and Health research programme focuses on the relationships between plant-based foods and human health, through integration of nutrition and agri-food science, and understanding the microbiome within and beyond the gastrointestinal tract. Our research is developing and trailing new plant-based food and microbiome-based intervention strategies to increase healthy human lifespans. We study interactions between plant-based foods, the gut and our health both in our state-of-the-art laboratories and through clinical studies.

The Human Studies team are key to planning, delivering and analysing studies involving human participants as part of our Food, Microbiome and Health research programme. Studies are often based at our purpose-built NIHR Clinical Research Facility and can involve our partners the Norfolk and Norwich University Hospital and University of East Anglia. We manage Patient and Public Involvement (PPI) groups which give members of the public the opportunity to inform and inspire our scientists to make sure research is relevant and inclusive.

Our expert team helps and trains scientists to secure ethical approval, conduct study visits, collect samples and engage with participants.

Living in Norfolk

• Visit Norfolk
• Schools in Norfolk
• Childcare in Norfolk

Microbiome and Health Human Studies Lead

Applications are invited for a Microbiome and Health Human Studies Lead to join the Food, Microbiome and Health programme at Quadram Institute Bioscience (QIB), based in Norwich, UK.

Background:

Our Food, Microbiome and Health research programme focuses on the relationships between plant-based foods and human health, through integration of nutrition and agri-food science, and understanding the microbiome within and beyond the gastrointestinal tract. Our research is developing and trailing new plant-based food and microbiome-based intervention strategies to increase healthy human lifespans. We study interactions between plant-based foods, the gut and our health both in our state-of-the-art laboratories and through clinical studies.

The Human Studies team are key to planning, delivering and analysing studies involving human participants as part of our Food, Microbiome and Health research programme. Studies are often based at our purpose-built NIHR Clinical Research Facility and can involve our partners the Norfolk and Norwich University Hospital and University of East Anglia. We manage Patient and Public Involvement (PPI) groups which give members of the public the opportunity to inform and inspire our scientists to make sure research is relevant and inclusive.

The role:

The Microbiome and Health Human Studies Lead will oversee the design, implementation, and management of gut microbiome-based human studies delivered by the Food, Microbiome and Health Programme (FMH ISP). This post will ensure the highest ethical and regulatory standards are met while advancing our mission. They will work closely with the FMH ISP Food and Health Human Studies Lead and QIB Human Research Governance Lead, and they will manage and support a team of Human Studies Facilitators.

The ideal candidate:

The successful candidate will have a BSc in a relevant discipline, with significant experience of managing research studies involving recruitment of human participants or human tissue (public health, industry and/or academic). It is advantageous that you have experience of collecting, handling, and processing biological samples for microbiome analysis.

Candidates should be proactive and organised with strong leadership skills, and with a deep understanding of human research processes. Ability to navigate complex regulatory landscapes is required.

This is a great opportunity for individuals who are particularly interested in contributing to world-leading microbiome research and shape the future of human studies at the Quadram Institute. 

Additional information:

Salary on appointment will be within the range £44,500 to £55,000 per annum depending on qualifications and experience. This is a full-time post for a contract of 36 months.

This role meets the criteria for a visa application, and we encourage all qualified candidates to apply.  Please contact the Human Resources Team if you have any questions regarding your application or visa options.

Interviews will be held on 25 March 2025.

We are committed to equal opportunities and welcome applications from all sectors of society.  The Institute supports equality of opportunity within the workplace and expects all employees to share and display these values.  To support our commitment, we have a range of family, faith and diversity friendly working arrangements to help all staff achieve excellence in their area of work.

As a Disability Confident employer, we guarantee to offer an interview to all disabled applicants who meet the essential criteria for this vacancy.

About the Quadram Institute:

The Quadram Institute is a new interdisciplinary research institute dedicated to understanding how food and microbes interact to promote health and prevent disease. Its mission is to deliver healthier lives through innovation in gut health, microbiology and food. A partnership between Quadram Institute Bioscience, the University of East Anglia, the Norfolk and Norwich University Hospital and BBSRC, it brings together scientists and clinicians in a state-of-the-art building on the Norwich Research Park. This is one of Europe’s largest centres of life sciences and home of the John Innes Centre and The Earlham Institute. (https://quadram.ac.uk/).

The closing date for applications will be 21 February 2025. 

The Quadram Institute Bioscience is a registered charity (No. 1058499) and is an Equal Opportunities Employer.