Salary for this Role:
From £46,500 per annum
Clinical Translation Manager - Translation
Reports to: Head of Translational Science
Closing date: 14 June 2021 at 23:59
This is a full time, permanent position on Crick terms and conditions of employment.
The Francis Crick Institute is a biomedical discovery institute dedicated to understanding the fundamental biology underlying health and disease. Its work is helping to understand why disease develops and to translate discoveries into new ways to prevent, diagnose and treat illnesses such as cancer, heart disease, stroke, infections, and neurodegenerative diseases.
An independent organisation, its founding partners are the Medical Research Council (MRC), Cancer Research UK, Wellcome, UCL (University College London), Imperial College London and King’s College London.
The institute is a leading centre of biomedical research and innovation. It promotes connections between researchers and disciplines and between academic institutions, healthcare organisations and businesses. Dedicated to research excellence, the institute has the scale, vision and expertise to tackle the most challenging scientific questions underpinning health and disease. It has a strong national role — training scientists and developing ideas for public good.
The Crick has placed an emphasis on promoting an openness to translation within the institute, supported by a small embedded translation team who are fully integrated with the day to day scientific life of the institute, and who provide easy access to expertise and mechanisms to convert discoveries toward applications. The focus of the translation team is on speed and the reduction of barriers to maximise the uptake and exploitation of ideas to real-world impact. By 2030, the Crick aims to have multiple examples of applications based on its science being tested in human trials as well as technology developed at the Crick being adopted to advance biomedical research.
A significant proportion of the Crick’s research involves the use of samples from human donors. The post-holder will be expected to provide scientists with expert support and guidance in navigating the ethical and regulatory requirements for obtaining human samples and ensuring that Crick research complies with all appropriate legislation. In addition, they will be expected to provide effective support to the Translation team in improving access to samples and developing networks with other organisations involved in clinical and translational research. They will also be involved in the development of clinical protocols and regulatory documents required for the establishment of clinical studies associated with Crick translation projects.
These include but are not limited to:
- Working with and educating researchers in the use of human biological samples and be a champion for their use in research.
- Sourcing and providing guidance to researchers in obtaining human samples
- Producing relevant clinical protocols and patient information relevant to the projects
- Reviewing translational projects to identify potential need for human tissues and proactively work with researchers to procure routes to obtain them.
- Work with the Crick’s HTA Designated Individual in ensuring all translational projects involving human samples or subjects fulfil the appropriate regulatory requirements, where applicable e.g. HTA, GDPR and GCP, etc.
- Supporting and guiding researchers through the ethical review process (eg IRAS, biobank project applications)
- Ensure researchers are aware of their ethical, regulatory and data protection obligations.
- Assisting with the preparation of Participant Information Sheets and Consent forms
- Liaising with commercial organisations, universities, teaching hospitals, biobanks and BRCs
- Sign-posting interest between the Crick and the BRCs to nurture clinical research collaboration
- Providing training and workshops on Ethics approval processes and Regulatory requirements in relation to clinical translational science, as required
- Actively participating in the formulation of policies and processes, and the sharing of information
Key experience and competencies
The post holder should embody and demonstrate our core Crick values: bold, imaginative, open, dynamic and collegial, in addition to the following:
Knowledge, skills and experience
- A background either in the pharmaceutical industry, CRO, biotech, medicine or life sciences
- Solid experience in managing clinical regulation and trials
- Good knowledge in regulatory and ethical guidelines for undertaking research on human subjects and their tissue
- Experience of managing projects with a number of cross-functional teams
- Working knowledge of the Human Tissue Act 2004
- Working knowledge of GDPR requirements
- Ability to review and advise on research proposal involving human biological samples
- Experience of accessing samples from Biobanks or existing trials
- A sound knowledge of Good Research Practice
- Demonstrable experience of setting up and managing quality procedures and writing policies and SOPs
- Self-starter with the ability to offer sound advice to scientists around the use of human biological samples in their research
- Good influencing and negotiating skills
- Good communication skills, including the ability to understand, interpret and convey complex documents and issues
- Computer literacy, including a working knowledge of MS Office
Qualifications, experience and competencies:
- Post-graduate qualification
- Industry experience
- Awareness of sample tracking databases
- Positive attitude and work ethic
- Attention to detail
- Ability to work without supervision
- Flexibility and a willingness to learn
- Honesty and a respect for confidentiality
- Commitment to continuous improvement of service delivery