Job summary An exciting opportunity has arisen to make a significant impact to the growing portfolio of advanced therapy clinical trials in the Newcastle Hospitals by leading and supporting the set-up, approvals and delivery of ATIMP studies across several disease areas. Newcastle Hospitals is one of the leading centres in the UK for facilitating advanced therapy research and the implementation of licensed cell and gene therapy products. This post has been enabled by the Northern Alliance Advanced Therapy Treatment Centre (NAATTC), As well as making a significant impact to the patients in Newcastle recruited to advanced therapy trials you will also support the wider aims of the ATTC network in addressing some of the complex local and national barriers that exist.You will be based within the NIHR Clinical Research Facility and will co-ordinate and oversee ATIMP research activity trust wide, bringing together colleagues from different areas to accelerate setup and implementation of these complex and exciting trials. You will have the opportunity to work with clinical, regulatory and scientific teams working together to increase our activity in advanced therapeutics. Interview Date Thursday, 21 November 2024 37 Hours 30 Minutes/Week You will be redirected to Trac to apply for the vacancy. Please expand the job details section and read all of the information before applying for the vacancy Main duties of the job Act as a main point of contact for clinical trials involving Advanced Therapy Investigational Medicinal Products (ATIMPs), providing advice, practical support and guidance during the setup, approvals and implementation process. Responsible for improving delivery, accelerate the setup and increase a broad portfolio of ATIMP studies. Co-ordinate and oversee ATIMP research activity trust wide, bringing together colleagues from different areas to accelerate setup and implementation of trials. Participate in the design and delivery of relevant and specific ATIMP education programs and will identify and meet the training needs of research support staff. Chair an operational group cross-department with the aim of tracking, reporting, and accelerating the setup of ATIMP trials. Will support the delivery of the Northern Alliance Advanced Therapies Treatment Centre (NA-ATTC) by supporting the ATTC network's ATIMP clinical trial programme, providing reporting and data collection as required and participating actively in local and national meetings. About us Newcastle Hospitals NHS Foundation Trust is one of the busiest, largest and most successful teaching NHS foundation trusts in the country, with around 16,000 staff and an annual income of £1 billion. We have a long history of providing high quality care, clinical excellence, and innovation in medical research regionally, nationally and internationally. We're also proud to be the second largest provider of specialised services in the country. This means we support people with a range of rare and complex medical, surgical and neurological conditions, cancers and genetic orders. Our staff oversee around 2 million patients 'contacts' each year, delivering high standards of healthcare. Please see attached information on what Staff Benefits we have to offer at our Trust. We are committed to promoting equality and diversity and recognise the benefit in providing an inclusive environment. We value and respect the diversity of our employees and aim to recruit a workforce which reflects the communities we serve, and is equipped to deliver the best service to our patients. We welcome all applications irrespective of people's race, disability, gender, sexual orientation, religion or belief, age, gender identity, marriage and civil partnership, pregnancy and maternity and in particular those from under- represented groups. Date posted 22 October 2024 Pay scheme Agenda for change Band Band 7 Salary £46,148 to £52,809 a year per annum Contract Fixed term Duration 39 months Working pattern Full-time Reference number 317-2024-41-021 Job locations Royal Victoria Infirmary 317 02 Royal Victoria Infirmary NE1 4LP Job description Job responsibilities Working with the multi-disciplinary team, the post holder will be responsible for the coordination of resource and leading activity to improve delivery, accelerate the setup, and increase a broad portfolio of ATIMP studies. Will co-ordinate and oversee ATIMP research activity trust wide, bringing together colleagues from different areas to accelerate setup and implementation of trials. Will participate in the design and delivery of relevant and specific ATIMP education programs and will identify and meet the training needs of research support staff. This will include the delivery of any education and training programs developed by the NA-ATTC ATIMP clinical trial programme. Provide governance expertise and support, liaising closely with the NJRO, as required. To support in the delivery of agreed performance targets. In conjunction with the multidisciplinary team the post holder will facilitate the delivery of ATIMP clinical research in line with contractual agreements. Work closely with Finance and ensure budgetary management within teams, including appropriate study costing and rigorous recording of all research activity to enable timely invoicing. To lead or contribute to cross-specialty and cross-directorate ATMIP projects to deliver improvement, objectives or the strategic priorities and vision of the Research Directorate and Trust. As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you. Please note it is a requirement of The Newcastle upon Tyne Hospitals NHS Foundation Trust that all successful candidates who require a DBS for the post they have been offered pay for their DBS certificate. The method of payment is a salary deduction from your first months pay. Job description Job responsibilities Working with the multi-disciplinary team, the post holder will be responsible for the coordination of resource and leading activity to improve delivery, accelerate the setup, and increase a broad portfolio of ATIMP studies. Will co-ordinate and oversee ATIMP research activity trust wide, bringing together colleagues from different areas to accelerate setup and implementation of trials. Will participate in the design and delivery of relevant and specific ATIMP education programs and will identify and meet the training needs of research support staff. This will include the delivery of any education and training programs developed by the NA-ATTC ATIMP clinical trial programme. Provide governance expertise and support, liaising closely with the NJRO, as required. To support in the delivery of agreed performance targets. In conjunction with the multidisciplinary team the post holder will facilitate the delivery of ATIMP clinical research in line with contractual agreements. Work closely with Finance and ensure budgetary management within teams, including appropriate study costing and rigorous recording of all research activity to enable timely invoicing. To lead or contribute to cross-specialty and cross-directorate ATMIP projects to deliver improvement, objectives or the strategic priorities and vision of the Research Directorate and Trust. As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you. Please note it is a requirement of The Newcastle upon Tyne Hospitals NHS Foundation Trust that all successful candidates who require a DBS for the post they have been offered pay for their DBS certificate. The method of payment is a salary deduction from your first months pay. Person Specification Qualifications & Education Essential Educated to degree level in a relevant subject Desirable Educated to degree level in a relevant subject Management qualification Leadership qualification Knowledge & Experience Essential Knowledge and understanding of UK research regulations Significant experience of conducting and managing clinical trials, including setup and delivery Knowledge and understanding of relevant local, regional and national NHS policies and frameworks relevant to the role Experience of clinical research study budgetary oversight, costing and financial trials management Management experience with developed skills including change management, team leadership and team development to master's level equivalent Ability to demonstrate extensive knowledge and experience of working to ICH GCP standards Desirable Advanced therapies research specific knowledge and experience Experience of the setup and management of Advanced Therapy Investigational Medicinal Product (ATIMP) clinical trials Experience of working with research funders, including industry and NHS Skills & Abilities Essential Excellent communication skills and ability to facilitate collaborative working relationships Highly skilled negotiator IT skills including competence in standard PC packages (e.g. word, Excel, Outlook Ability to work as part of the multi-disciplinary team to facilitate successful study delivery through all stages of the research process Person Specification Qualifications & Education Essential Educated to degree level in a relevant subject Desirable Educated to degree level in a relevant subject Management qualification Leadership qualification Knowledge & Experience Essential Knowledge and understanding of UK research regulations Significant experience of conducting and managing clinical trials, including setup and delivery Knowledge and understanding of relevant local, regional and national NHS policies and frameworks relevant to the role Experience of clinical research study budgetary oversight, costing and financial trials management Management experience with developed skills including change management, team leadership and team development to master's level equivalent Ability to demonstrate extensive knowledge and experience of working to ICH GCP standards Desirable Advanced therapies research specific knowledge and experience Experience of the setup and management of Advanced Therapy Investigational Medicinal Product (ATIMP) clinical trials Experience of working with research funders, including industry and NHS Skills & Abilities Essential Excellent communication skills and ability to facilitate collaborative working relationships Highly skilled negotiator IT skills including competence in standard PC packages (e.g. word, Excel, Outlook Ability to work as part of the multi-disciplinary team to facilitate successful study delivery through all stages of the research process Disclosure and Barring Service Check This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions. Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab). From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab). Additional information Disclosure and Barring Service Check This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions. Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab). From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab). Employer details Employer name The Newcastle upon Tyne Hospitals NHS Foundation Trust Address Royal Victoria Infirmary 317 02 Royal Victoria Infirmary NE1 4LP Employer's website https://careers.nuth.nhs.uk/why-us (Opens in a new tab)