- To further develop, implement and review the Crick's Quality Management System to ensure regulatory and compliance requirements are met. To ensure that the procurement, receipt, storage, use and disposal of human material is carried out in a safe, sensitive and ethical manner, in compliance with the requirements of the Human Tissue Act. Maintain a register of all projects involving relevant human tissues, and tissues being stored under Health Research Authority approval. To lead audit and assurance activities relating to human tissues. Monitor compliance through regular risk-based audits. Writing audit reports, issuing corrective actions, and monitoring their implementation and effectiveness. Reporting on audit findings to relevant committees and performing appropriate analysis to identify areas for improvement at an institutional level. Developing and monitoring Key Performance Indicators (KPIs) and the provision of reports on compliance, escalating compliance matters as appropriate.
- Co-ordinate, mentor and support a network of Person's Designate, including organizing and chairing meetings. Ensure regulatory compliance through training, advice and audit; hosting inspectors and compiling reports. Coordinate the Crick's preparation for HTA regulatory & inspection activities. Ensure that the Crick remains inspection ready. Lead on the investigation and reporting of adverse events relating to human tissues, and the oversight of corrective and preventative actions. Monitor the regulatory framework relating to Human Tissues, and sector best practice, and lead on the development of plans to respond to changes. Actively participate in the formulation of policies and processes Develop and deliver training to facilitate compliance Assist with the configuration and administration of any associated sample tracking databases Build and maintain a network of external sources of human tissues for research, such as biobanks. Develop resources and provide advice to help signpost researchers towards appropriate routes to accessing tissues. Undertake other duties as required by the Head of Human Research governance, including leading or contributing to project work.
- Support science staff working within the scope of Human Biology, including compliance, governance and ethical requirements. Providing guidance and signposting to relevant services (internally and externally) and helping to navigate barriers. Support the development and implementation of processes that enable human biology research, seeking opportunities for continuous improvement. Provide project management support for a number of human biology projects. Contribute to the management of a human biology enquiries inbox. Record project/compliance specific information in databases and maintaining contemporaneous records.
- A background either in the pharmaceutical industry, medicine, or life sciences Good knowledge in regulatory and ethical guidelines for undertaking research on human participants and their tissue, particularly the Human Tissue Act 2004 and the requirements set out in the relevant Codes of Practice Experience in developing quality-based management systems, writing and implementing policies and guidance and a sound understanding of quality assurance. Experience in designing and delivering audits, writing audit reports and monitoring of audit actions Ability to review and advise on research proposals involving human biological samples Demonstrable experience of setting up and managing quality procedures and writing policies and SOPs (Standard Operating Procedures) Excellent organisational, analytical, and problem-solving skills. An ability to listen to and synthetise complex information (including scientific/technical details) and identify key actions. Effective verbal communication skills, with an ability to communicate well with different stakeholders within the Crick and with external contacts Strong written communication skills with experience of writing reports, audit documents policies and procedures Excellent interpersonal skills, with an ability to manage expectations and persuade others. Ability to work with both a high degree of autonomy with a broad range of researchers, and as part of a small team. A learning mindset and commitment to continuous improvement
- A willingness to act as the Crick's Designated Individual Qualified to act as a lead auditor Experience of managing sample tracking databases (e.g., Freezer Pro, Item Tracker) Working knowledge of the broader governance landscape including Human Fertilisation and Embryology, research ethics, GDPR (General Data Protection Regulation) and research contracting Experience of accessing samples from Biobanks or existing trials
Human Tissue Governance Manager - Central London, United Kingdom - The Francis Crick Institute
Description
Reports to: Head of Human Research Governance
This is a full-time permanent position on Crick terms and conditions of employment.
About Us
The Francis Crick Institute is an independent charity established to be a UK flagship for discovery research in biomedicine.
Join us as we work to explore biology at all levels, from molecules through cells to entire organisms.
Our mission is to understand more about how living things work to help improve treatment, diagnosis and prevention of human disease and achieve economic opportunities for the UK.
In our Institute, more than 1,500 staff and students use their wide-ranging knowledge and expertise to work across disciplines.
We combine this rigour with an open and interactive culture. We are committed to bringing together people with varied research interests and expertise, including clinicians, physical scientists, and applied scientists from our pharmaceutical partners, to achieve our increasingly ambitious goals.
The Human Biology Facility provides support and expertise to enable research utilising human materials and data, and to develop capability in core areas relating to stem cells, genetic modification and human model systems. We provide support to Crick researchers, including our growing number of clinical scientists, throughout the study lifecycle including sourcing human materials, navigating governance frameworks, evidencing compliance, and providing expert technical advice. We foster interactions between our scientists, support teams and external networks to facilitate our research to benefit human health. The Facility has two core functions, a Human Research Governance Team, and Models Laboratory Group.
Summary
The Human Tissue Governance Manager will be a key member of the Human Research Governance Team, working closely with both operation teams and with science colleagues at all levels. The team is the central point of contact for all matters relating to research involving human materials or data. It leads on our compliance and governance obligations, including the ethical use of human samples and data, Human Tissue Act (HTA) requirements, and provides support to researchers to navigate the necessary requirements. The team help source samples by building a network of resources and external collaborators and relationships.
The post holder will be responsible for leading our programme of activities to ensure compliance with the Human Tissue Act and associated frameworks. You will play a key role in developing and maintaining our quality management system and leading our associated programme of assurance activities. The post-holder will provide expert and accessible guidance to the Crick community on human tissue requirements and mechanisms to access human tissues. They will play an important role in driving a culture of continuous improvement and ensuring the Crick remains HTA-inspection ready.
This role has no budget responsibilities and no direct reports.
Key Responsibilities
To include but not limited to:
Human Biology Project Support
Knowledge, skills and experience(essential)
Knowledge,skills and experience(desirable)