Clinical Research Practitioner

The post-holder will work across the clinical and administrative areas of the Lung Research Team. In clinical areas, they will work under the supervision and delegation of clinical research nurses and investigators, providing patient support within the limits of their competence.

Duties may include collecting biological samples, recording observations and data, and completing quality-of-life questionnaires with trial participants. In administrative areas, they will work with trial coordinators and research managers to support a portfolio of clinical projects. Responsibilities include entering visit data, responding to trial queries, maintaining trial records and essential documents, supporting invoicing, liaising with Research and Innovation colleagues and pharmaceutical contacts, and assisting with wider administrative tasks.

The post-holder will participate fully in personal development and review and should hold, or be working towards, the National Care Certificate.

Full training and further development opportunities are provided. The Lung team delivers early-phase, biomarker, real-world data, radiotherapy and biobanking studies.

This challenging and rewarding role offers the opportunity to join a friendly, hard-working team committed to research, high-quality patient care and improved cancer outcomes.

The specific responsibilities will depend on the requirements of each team, but may include:

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, 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.

WORKING PRACTICE

Work closely with the Research Divisions 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 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.

Essential: - Minimum GCSE or equivalent Math and English. NVQ level 3 or relevant experience

Desirable: - A research qualification / clinical research training; - Degree in science or health-related discipline; - National Care certificate (Christie Care Certificate)

Essential: - Experience of working in a research environment Or Experience working in a healthcare environment

Desirable: - Data management experience; - Clinical research experience; - Phlebotomy skills

Essential: - IT skills. Experience of using Email, Excel, Word and Outlook

Desirable: - Evidence of IT training; - Intra-venous access training, or a willingness to undertake this

Essential: - Awareness of ICH "Good Clinical Practice"; - Knowledge and understanding of patient observations

Desirable: - Knowledge of the clinical trial process; - Understanding of medical terminology and cancer; - Knowledge of patient information systems

Essential: - Ability to demonstrate the organisational values and behaviours

Essential: - Ability to work on own initiative; - Ability to organise and prioritise own workload; - Ability to work as part of a multi-disciplinary team; - Able to work flexibly and to tight deadlines; - Ability to communicate effectively at all levels