Human Tissue Governance Manager

Job Description & Person Specification

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:

• 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.
• 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.

Human Biology Project Support:

• 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.

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