Clinical Research Practitioner
Job summary
Please note that these posts are permanent contracts at 37.5 hours per week.
We are looking to appoint a Research Practitioner (Band 4) in the Melanoma Research team within The Christie NHS Foundation Trust. The research teams form part of the Research and Innovation division and are made up of a multi-disciplinary group of staff who are dedicated to cancer research and treatment.
We are seeking an enthusiastic, motivated, and experienced individual who will be responsible for assisting the research nurses, consultants and trial management team with the delivery of clinical research projects and clinical trials. We are looking for an individual who is able to demonstrate work experience in data management involving clinical trials, good understanding of clinical research, GCP and clinical trial governance. Strong candidates will have excellent organisation and communication skills, work well both in a team and using their own initiative.
Applicants should meet all the essential criteria on the job description as a minimum. We are looking for a candidate with good organisational and communication skills, with the ability to multi-task. Due to the vital nature of our work and the impact on patients and the research community, attention to detail is an essential skill.
An informal conversation to discuss the post is highly recommended.
Main duties of the job
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.
About us
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.
Job description
Job responsibilities
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.
RESEARCHAct 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 VALUESDemonstrates the agreed set of values and accountable for own attitude and behaviour.
Person Specification
Qualifications
- Diploma or relevant experience
- A research qualification / clinical research training
- Degree in science or health-related discipline
- National Care certificate (Christie Care Certificate)
Experience
- Experience of working in a research environment Or Experience working in a healthcare environment
- Data management experience
- Clinical research experience
- phlebotomy skills
Skills
- IT skills. Experience of using Email, Excel, Word and Outlook
- Evidence of IT training
- Intra-venous access training, or a willingness to undertake this
Knowledge
- Awareness of ICH "Good Clinical Practice"
- Knowledge and understanding of patient observations
- Knowledge of the clinical trial process
- Understanding of medical terminology and cancer
- Knowledge of patient information systems
Vaues
- Ability to demonstrate the organisational values and behaviours
Other
- 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
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Certificate of Sponsorship
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website.
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants.
Employer details
Employer name
The Christie NHS FT
Address
Melanoma - Q01060
Manchester
M20 4BX
United Kingdom
Employer's website
https://www.christie.nhs.uk/