The main purpose of the role is to support the Surgical and Anaesthetic research team with all aspects of surgical and anaesthetic research study administration including clinical research trials, according to Good Clinical Practice (GCP), standard operating procedures (SOPs) and Trust policies.
The post holder will be supported to undertake the Level 3 Business Administrator apprenticeship qualification alongside the AMSPAR Level 2 in Medical Terminology qualification.
The post holder will support the Research Team in the administration of research studies from feasibility to archiving including (but not limited to):
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.
Job description
Job responsibilities
DUTIES AND RESPONSIBILITIES
The specific responsibilities will depend on the requirements of the surgical and anaesthetic research team, but may include:
Act as a point of contact for the Core Research and Innovation team, study sponsors, clinical research organisations and specific research teams. Communicating directly with them regarding data queries, monitoring visits and other enquiries relevant to research study set up, study activity and progress.
Responsible for study set up and initiation of allocated research trials within the research team, under the guidance of the Research Project Manager, Senior Research Nurse and named experienced team members.
Maintain investigator site files, associated research study files and essential documentation in accordance with ICH-GCP and Trust SOPs to ensure they are kept inspection ready at all times.
Process study amendments for allocated research studies in line with ICH-GCP and Research and Innovation SOPs and timelines.
Provide administrative support to the Principal Investigator, Research Project Manager and Research Nurses in relation to safety reporting in accordance with study protocol requirements.
Help maintain and complete team reporting mechanism, for example but not limited to recruitment logs, patient visit logs, costing spreadsheets, case report trackers and electronic pro-formas.
Produce research trial work-booklets for assigned studies, to be reviewed by the Research Project Manager, Research Nurse and Principal Investigator to help support the research team with the collection of study data. This will include ensuring version control and amending when necessary.
To prepare for monitoring visits which will include the collection of clinical case notes for patients on research trials and other documentation for monitoring and audit purposes.
Complete paper CRF and eCRFs as per sponsor and study requirements, liaising with trial monitors and Research Project Manager to ensure data submitted is valid and requirements for audits and monitoring visits are met.
Cross check, confirm data and complete query resolutions for allocated studies with relevant personnel i.e. sponsor representatives, Research Project Manager, Research Nurse, Chief and Principal Investigators and third parties.
Completion of research databases with data from various sources such as questionnaires, hospital records, electronic and paper sources.
Liaise with internal and external NHS staff regarding case notes, data collection, archival tumour blocks, mortality data and other general research study activity, which maybe confidential and sensitive in nature.
Arrange the shipping and delivery for allocated research study resources including but not limited to medical devices, study documentation and data and study samples.
Assist the Research Project Manager with the tracking of payments for research trials and surgical research biopsy activity including completion of any necessary documentation and logs
Liaise with the MCRC BioBank in relation to allocated research studies in respect of tissue study sample collection and dispatch.
Assist the Research Project Manager and Chief Investigators with the development of Research Databases.
Assist the Research Project Manager with surgical research biopsy data and administration in preparation for reports, audits and presentations.
Support the Research Project Manager with allocated tasks to assist them with the smooth running of surgical research biopsy services.
Undertake general administrative duties as delegated by Research Project Manager to contribute to the smooth running of research studies for the research team.
Demonstrate the agreed set of values and accountable for own attitude and behaviour.
WORKING PRACTICE
Work closely with the Research Project Manager to assist with the adherence of new research team and the Research and Innovation Divisions SOPs and new procedures are rolled out within the research team.
Be pro-active in providing feedback on working practices within the research team and suggest new ways of working.
The post holder is expected to use initiative and be able to work independently without close supervision. They are also expected to plan and organise their own time and workload activity with prioritisation, referring to the Research Project Manager as necessary.
The post holder is guided by relevant protocols and SOPs and expected to exercise judgment outside of these areas.
The post holder is expected to attend regular meetings with the Research Project Manager and other Research and Innovation staff who will also be available as point of reference for queries.
PERSONAL AND PEOPLE DEVELOPMENT
Maintain professional development whilst evaluating own specialist knowledge with assistance from the assigned line manager, to satisfy the NHS Knowledge and Skills Framework.
Participate in Trust-wide education programmes and study days, regional and national meetings and research seminars as appropriate
Support with induction, for new holders under the direction of the Research and Innovation Division
PHYSICAL, MENTAL AND EMOTIONAL EFFORT
Long periods of time spent using a keyboard to input information and use of VDU for electronic communication
Prolonged concentration is regularly required e.g. when checking through research documentation and entering data into case report forms and spreadsheets
Occasional exposure to distressing information as research patients may be treated with life limited conditions
