An exciting opportunity to be the national lead for a Prostate Cancer UK (PCUK) research study. We are looking for an enthusiastic and highly motivated individual with excellent organisational and communication skills and previous experience in the set-up and delivery of clinical research projects.
This project aims to evaluate and validate the Pancreatic Cancer Reporting Template-UK (PACT-UK) tool and develop the countries first imaging biobank for pancreatic cancer. The PACT-UK structured reporting tool supports clinical decision-making in Regional Specialist Pancreatic Cancer Multidisciplinary Teams (MDTs) for non-metastatic pancreatic cancer.
The is a collaboration between The Institute of Cancer Research, Leeds Teaching Hospitals and The Christie NHS Foundation Trust, along will a network of five participating centres across the UK. This will be a highly collaborative project and is a fantastic opportunity for someone with research experience looking to develop the breadth of their leadership skills.
The post holder may work remotely or work at The Christie NHS Foundation Trust in Manchester or The Institute of Cancer Research in London, they will need to be onsite for an induction at both centres. The post holder will be expected to travel between the five participating centres throughout the year to establish the project and provide training to sites (Leeds, Cambridge, Glasgow, Newcastle, Manchester).

The post holder will be able to show professional qualifications, skills and experience in order to perform the following key duties:

• Provide lead administration for the development of the Image Biobank for validation of the PACT UK Standardised Radiology Reporting tool for Pancreatic Cancer.
• Responsible for preparation and submission of the ethics and HRA application for the imaging biobank.
• Facilitate the implementation of data-sharing agreements between the five participating centres and ensure agreements comply with data protection regulations and biobank standards.
• Ensure that the project meets all legal and regulatory obligations in compliance with the UK Policy Framework for Health and Social Care Research.
• Provide support to the project team in set-up; including organisation of relevant meetings and the production of action logs and minutes.
• Liaise with a wide range of academic, clinical, and administrative staff throughout, and external to, the Trust, including grant funding bodies.

Provide training and support to MDT coordinators across the five participating centres to perform data uploads.
The Christie is one of Europe’s leading cancer centres, treating over 60,000 patients a year. We are based in Manchester and serve a population of 3.2 million across Greater Manchester & Cheshire, but as a national specialist around 15% patients are referred to us from other parts of the country.
We provide radiotherapy through one of the largest radiotherapy departments in the world; chemotherapy on site and through 14 other hospitals; highly specialist surgery for complex and rare cancer; and a wide range of support and diagnostic services. We are also an international leader in research, with world first breakthroughs for over 100 years.
We run one of the largest early clinical trial units in Europe with over 300 trials every year. Cancer research in Manchester, most of which is undertaken on the Christie site, has been officially ranked the best in the UK.

DUTIES AND RESPONSIBILITIES

Research Project Management

• Input into issues of project feasibility from an early stage in grant application process
• Prepare and submit ethics and regulatory authority applications and amendments and ensure all approvals have been gained prior to research commencing
• Assist in the writing and evaluation of research protocols, patient information, questionnaires and other study documentation as applicable
• Good planning and organisational skills – able to plan project and make adjustments if needed
• Assist with management of patient & public involvement & engagement activities
• Advise and negotiate on clinical trial agreements including financial arrangements and material/data transfer agreements
• Develop and implement suitable tracking tools for all aspects of the project
• Take responsibility for site-initiation, data collection and monitoring, and on-going study management
• Identify strategies for increasing usability and uptake for the PACT-UK tool and supporting team members in implementing these strategies.
• Work to ensure patient recruitment targets and other project milestones are achieved
• Develop and manage the risk management strategy
• Maintain and update site files and study databases
• Conduct research activity within the research governance framework
• Maintain and develop a working knowledge of current legislation regarding participation in research, including research and clinical governance and data protection. Attending mandatory and specialist training (e.g. ICH GCP) in accordance with local policy and research governance

Finance/Budget Management

• Identify funding streams for potential grant applications
• Facilitate preparation and submission of research grant applications
• Assist in development of the project budget ensuring finances are well managed throughout the project duration; Working with NHS/University finance systems to raise purchase requisitions, receipt goods and check invoices are paid
• Day-to-day project budget management duties, including administering and monitoring the project budget, acting as budget holder for project
• Develop and maintain excellent working relationship with The Christie NHS Foundation Trust finance department and University Research Finance/Support/Contracts to provide detailed costings for research projects and to troubleshoot any issues that arise

Communications

• Serve as a main point of contact for research teams and study investigators, external funding bodies, pharmaceutical companies etc, as applicable
• Support researchers with internal and external communication so that collaborations are maximized
• Support with training of MDTs in collaborating centres to upload data onto and utilise the biobank
• Liaise with a wide range of academic, clinical, managerial and administrative staff throughout the Trust, and other academic and healthcare institutions, both nationally and internationally
• Communicate persuasively to project boards and staff to the requirements of the project, negotiates with and motivates sites on project delivery, including linking with other initiatives,
• Communicates sensitive information about performance and change, makes routine/complex formal presentations to large groups
• Arrange meetings, prepare agendas, take minutes and distribute as appropriate, following up any action points; includes study team meetings, study initiation visits etc
• Draft abstracts and posters for local, national and international conferences
• Write regular updates or newsletters to keep collaborators up to date with developments
• Prepare and submit interim and annual reports for R&I, ethics committees, funding bodies, etc. as required
• Proofread and edit manuscripts before submission to scientific journals. Coordinate the process from submission to publication
• Where appropriate link with the Manchester Cancer Research Centre (MCRC) and the Manchester Academic Health Science Centre (MAHSC)
• Organise external collaborative and training meetings: invite speakers, book venue, liaise with organisers and attendees, advertise event
• Contribute to research project web site design and content, if required.

Other

• Able to exercise analytical and critical thinking - assimilating complex facts or situations, requiring interpretation, comparison of a range of options to meet project standards
• Contribute to training programmes for R&D and other clinical staff
• Contribute to the development of systems and infrastructure, such as SOP development, business development activities and financial management
• Assist with preparation for and presentation of reviews/audits/inspections (e.g., MHRA, in-house audits etc).
• Contribute to any process improvement initiatives.
• Line management of junior staff
• Contribute to Cancer Research Project Manager Network activities

Training and Personal Development

• Maintain professional development whilst evaluating own specialist knowledge through a process of appraisal and personal development planning to satisfy the NHS Knowledge and Skills Framework requirements relating to the job
• Participate in Trust-wide education programmes and study days, regional and national meetings and research seminars as appropriate
• Acquire and maintain a working knowledge of key research areas
• Develop and maintain effective working relationships with internal and external partners.

The post holder will be able to show professional qualifications, skills and experience in order to perform the following key duties:

• Provide lead administration for the development of the Image Biobank for validation of the PACT UK Standardised Radiology Reporting tool for Pancreatic Cancer.
• Responsible for preparation and submission of the ethics and HRA application for the imaging biobank.
• Facilitate the implementation of data-sharing agreements between the five participating centres and ensure agreements comply with data protection regulations and biobank standards.
• Ensure that the project meets all legal and regulatory obligations in compliance with the UK Policy Framework for Health and Social Care Research.
• Provide support to the project team in set-up; including organisation of relevant meetings and the production of action logs and minutes.
• Liaise with a wide range of academic, clinical, and administrative staff throughout, and external to, the Trust, including grant funding bodies