Clinical Research Practitioner

The post holder will work across both the clinical and administrative functions of the Melanoma Research Team, supporting the delivery of a diverse portfolio of research studies. Clinical duties, undertaken under the supervision of clinical research nurses, will include providing patient support within agreed competencies, collecting biological samples, recording observations, gathering study data, and administering quality of life questionnaires. Administrative responsibilities, supported by the Research Manager, will include managing aspects of clinical research projects, entering patient visit data, responding to study queries, maintaining trial records, filing essential documents, supporting invoicing processes, liaising with pharmaceutical companies, collaborating with the wider R&I team, and assisting with general administrative activities.

Post holders will actively participate in their personal development and appraisal process to achieve role objectives and should hold, or be working towards, the National Care Certificate.

The Melanoma Research Team has a strong collaborative ethos, requiring close working relationships with a wide range of staff. Full training and ongoing development opportunities are provided to support career progression within the Trust. This is a challenging but rewarding role within a supportive, dedicated team committed to excellence in research and patient care.

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 activitiesConduct 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, 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.

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.

KEY VALUES Demonstrates the agreed set of values and accountable for own attitude and behaviour.

The Christie is one of Europe's leading cancer centres, looking after more than 64,000 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 25% patients are referred to us from other parts of the country.

We are the largest radiotherapy provider in the NHS with one in 20 treatments delivered at The Christie. We have up to 15 linear accelerators operating across our network of sites. We operate the largest chemotherapy unit in the UK on our main site and treatments are also provided at 13 other networked sites, and in patients homes. And as a specialist tertiary surgical centre, we focus on rare cancers, complex procedures, and multidisciplinary approaches to cancer surgery, specialising in colorectal, peritoneal, gynaecological, urological and plastic surgery.

We are also an international leader in research, with world first breakthroughs for over 100 years. We have been named by the UK's National Institute for Health Research (NIHR), as one of the best hospitals providing opportunities for patients to participate in clinical research studies, with more than 800 studies open at any time, caring for over 3,000 patients.

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