The main purpose of the role is to support the Observational and Supportive, Pan Tumour and Endocrine Research Team clinical research team with all aspects of clinical trials administration, 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 Level 2 qualification in Medical Terminology, and receive one day for off-the-job learning per week.
Duties are separated into those the postholder can do from Day 1 (in green) and those they will progress into over time (in yellow).
The post holder will assist with the administration of clinical trials from feasibility to archiving including (but not limited to):
- Assist with the efficient and timely set up of clinical trials.
- Assist with the tracking and raising of invoices.
- Manage own workload for daily trial activity including case report form completion and amendment processing to meet internal and external deadlines.
- Assist with quality assurance of all trial related documentation in accordance with relevant legislation and guidelines.
- Assist with preparation for audit and inspections within assigned teams.
- General trial-related communication in accordance with the Data Protection Act.
Assist with maintenance of clinical trial documentation.
Act as a point of contact for the core Research and Development team, study sponsors, clinical research organisations and specific research teams, communicating directly with them.
- Maintain investigator site files and essential documentation in accordance with ICH-GCP and Trust SOPs.
- Complete case report forms as per sponsor requirements, and liaise with clinical trial monitors to ensure the data sent is valid and their requirements are met.
- Liaise with internal and external NHS staff regarding case notes, data collection, archival tumour blocks, mortality data, and other general trial activities.
- Undertake general administrative tasks as delegated by managerial representatives from the Research Division to contribute to the smooth running of the patient recruitment teams.
WORKING PRACTICE
- Work closely with the Research Division’s management team to ensure adherence to new SOPs and working procedures
- The post holder is expected to use initiative and be able to work independently without close supervision.
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.
PHYSICAL, MENTAL AND EMOTIONAL EFFORT
- Long periods of time spent using keyboard to input information and use of VDU for electronic
communication.
- Occasional exposure to distressing circumstances as trial patients are commonly suffering from terminal illnesses
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
The specific responsibilities will depend on the requirements of each team, but may include:
- Act as a point of contact for the core Research and Development team, study sponsors, clinical research organisations and specific research teams, communicating directly with them regarding data queries, monitoring visits and other enquiries relevant to trial set up and general trial conduct.
- Set up and initiation of allocated trials within an assigned team, under the guidance of an experienced team member.
- Track all payments throughout each clinical trial including completion of activity logs and requesting invoices to be raised.
- Maintain investigator site files and essential documentation in accordance with ICH-GCP and Trust SOPs to ensure they are kept inspection ready at all times.
- Process trial amendment submissions in accordance with ICH-GCP and Trust SOPs and timelines.
- Provide administrative support to the Clinical Research Nurses and Principal Investigators for safety reporting in accordance with protocol requirements.
- Complete team reporting mechanisms (i.e. recruitment activity logs, patient visit logs, costing spreadsheets, case report form trackers and electronic proformas).
- Produce trial workbooks for review by the lead Clinical Research Nurse and Principal Investigator for assigned studies and ensure version control is maintained.
- Ensure collection of clinical case notes for all patients, so that these are available as needed, for monitoring and audit purposes.
- Complete case report forms as per sponsor requirements, and liaise with clinical trial monitors to ensure the data sent is valid and their requirements are met at site monitoring visits.
- Cross check, confirm data and complete query resolution with sponsors and third parties in a timely manner.
- Completion of clinical trial specific databases with data from various sources such as questionnaires, hospital records and other electronic and paper sources.
- Liaise with internal and external NHS staff regarding case notes, data collection, archival tumour blocks, mortality data, and other general trial activities, which may be confidential and sensitive in nature.
- Arrange shipping and delivery of relevant trial data and documents including import/ export of tumour blocks, ECGs and copy scans.
- Arrange team and trial related meetings as required, producing minutes in a timely manner.
- Ensure that data is available and up to date for any meetings related to a clinical trial.
- If required attend project related meetings, investigator meetings (abroad or teleconferences, as necessary) to convey the relevant information to the study team.
- Assist with preparation for audit and inspections within assigned teams.
- Assist with trial document archiving by following the Trust’s archiving guidelines.
- Ensure that office/ trial related supplies are adequate and assist with the ordering process.
- Undertake general administrative tasks as delegated by managerial
representatives from the Research Division to contribute to the smooth running of the patient recruitment teams.
- Demonstrates the agreed set of values and accountable for own attitude and behaviour
WORKING PRACTICE
- Work closely with the Research Division’s management team to ensure adherence to new SOPs and working procedures rolled out divisionally.
- 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 Portfolio Support Manager as necessary.
- The post holder is guided by relevant protocols and SOPs, and expected to exercise judgement outside these areas. However, the Research Division’s managerial team members are available as point of reference for any queries and will meet regularly with staff.
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 post holders under the direction of the Research Division’s management team.
PHYSICAL, MENTAL AND EMOTIONAL EFFORT
- Long periods of time spent using keyboard to input information and use of VDU for electronic communication.
- Prolonged concentration is regularly required (e.g. when checking through trial documentation and entering data into spreadsheets).
- Occasional exposure to distressing circumstances as trial patients are commonly suffering from terminal illnesses.
