Apprentice Clinical Trials Coordinator

at  The Christie NHS Foundation Trust

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):
Assist with the efficient and timely set up research studies
Manage own workload for daily research activity including data collection, case report form completion and processing amendments to meet internal and external deadlines
Assist with the quality assurance of study related documentation in accordance with relevant legislation and guidelines
Assist with maintenance of research study documentation
Assist with preparation for audits, reviews and monitoring of assigned research studies
General study related communication in accordance with the Data Protection Act
Act as a liaison for the Core Research and Innovation team, study sponsors, clinical research organisations, and specific research teams, handling data queries, monitoring visits, and other research-related inquiries. Liaise with internal and external NHS staff regarding case notes, data collection, and other research activities, and arrange shipping and delivery for research study resources.
Responsible for setting up and initiating allocated research trials under the guidance of senior team members.
Maintain investigator site files and essential documentation in accordance with ICH-GCP and Trust SOPs, ensuring they are inspection-ready.
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, particularly in relation to safety reporting. Assist the Research Project Manager with tracking payments, developing research databases, and preparing for reports, audits, and presentations, while undertaking general administrative duties to ensure smooth running of research studies.
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.

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.