Job Description
We are recruiting a Band 4 Research Practitioner to join the Experimental Cancer Medicine Team (ECMT) covering a portfolio of early phase oncology clinical trials in all solid tumour types. ECMT works to deliver the next generation of cancer treatments including, Chemotherapy, Immunotherapy, targeted therapies, and other novel agents.
The post holder will work alongside a team of Consultants, Senior Clinical Research Nurses, Clinical Research Nurses, and Clinical Trial Administrators to deliver a range of complex treatments to a high standard of care.
Research at the Christie is supported through the R&I division and provides opportunities to develop research skills and knowledge with educational packages and support.
The post holder will be involved in the administrative coordination of a number of clinical research projects, including translational studies, and will be responsible for collecting, processing, shipping and tracking of biological samples, ensuring all tasks are undertaken in line with relevant legislation and governance requirements. This role will involve both office-based and clinical tasks such as venepuncture, cannulation and ECG’s as required. Experience within the clinical setting is desirable but not essential as full training can be provided.
The Band 4 Research Practitioner must have excellent communication and interpersonal skills as well as possessing a strong motivation to work in clinical research.
Flexibility in working is essential.
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.
Clinical
- Provide clinical care for research participants, as delegated by PIs and research nurses, within the boundaries of own knowledge, competence and skill level.
- Ensure that all research is undertaken according to Good Clinical Practice (GCP), standard operating procedures (SOPs) and Trust policies.
- Planning and organising day- to-day research and other activities
- Conduct delegated data collection with participants, such as questionnaires and interviews.
- Collection of biological samples as required for the clinical protocol, this may include blood, urine, sputum etc.
- Preparation of sampling kits as described in study laboratory manuals, maintaining laboratory stock and shipping & tracking of research samples.
- Undertake research-related activities as required such as clinical observations and NEWS2 appropriately escalating unwell patients to senior nursing and medical staff. Blood glucose monitoring, blood sampling (venepuncture and other venous access), PK sampling, cannulation and ECGs.
- Attend individual project meetings as required.
- Contribute to clinical and research governance processes, including adverse event and incident reporting, supporting any investigations.
- Understand and deliver care in accordance with regulatory approved clinical research protocols.
- Ensure all clinical activities are recorded in appropriate systems in a timely manner.
- Evening and weekend shifts may occasionally be required to meet the clinical needs of the service
- Lead and co-ordinate Clinics. Ensure documentation is prepared and ready for use by clinicians. Ensure tasks delegated appropriately.
Research
- 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 trial set up and general trial conduct.
- 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.
- 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.
- 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.
- Undertake general administrative tasks related to clinical trials as delegated by your line manager.
- Assist with preparation for audit and inspections within assigned teams.
- Facilitating team projects, internal studies and audits.
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 Senior Clinical Trials Coordinators/ Research Nurses as necessary.
Personal Education, Training and Development
- Undertake continuous professional development, seeking opportunities to enhance skills via a personal development plan.
- Participation in trust-wide education programmes and study days.
- To keep up to date with departmental, Trust, UK and EU developments for the management of clinical research ensuring timely, effective implementation of changes.
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