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Job summary

Main area
Melanoma - Q01060
Grade
Band 4
Contract
24 months (Fixed Term 2 Years)
Hours
Full time - 37.5 hours per week
Job ref
413-84863-RI-AK
Employer
The Christie NHS Foundation Trust
Employer type
NHS
Site
Melanoma - Q01060
Town
Manchester
Salary
£25,147 - £27,596 pro rota, per annum
Salary period
Yearly
Closing
30/07/2024 23:59

Employer heading

The Christie NHS Foundation Trust logo

Clinical Research Practitioner

Band 4

Job overview

Please note that this post is offered as a fixed term contract at 37.5 h/week for 2 years.

 

An exciting opportunity has arisen within the Research and Innovation Division at The Christie NHS Foundation Trust. We are looking to appoint a Clinical Research Practitioner to the Melanoma research delivery team within The Christie. We are seeking enthusiastic and highly motivated individuals to join an established research team with a varied portfolio of clinical trials as a Clinical Research Practitioner (CRP).

Key responsibilities of this role will be to support the melanoma team investigator-led and translational research portfolio. You will be involved in exciting cutting-edge trials using circulating tumour DNA to inform clinical decisions and will support translational sample collection, which feeds into novel laboratory research. In addition, you will assist with research into late effects of immune therapy through administering questionnaires to patients and performing (following training) cognitive assessments. The

This role is patient facing and as such the successful candidate will need to demonstrate excellent communication skills and the ability to work alongside clinical colleagues. Clinical skills training will be required for this role so a willingness to work towards these or demonstration that the candidate have these is essential.

Main duties of the job

Candidates must have excellent organisation and communication skills, who can work well both in a team and using their own initiative. The individuals must demonstrate skills that will promote an environment of quality and learning.

Applicants should meet all the essential criteria described in the job description as a minimum.

The CRP will be involved in varied portfolio activities including; patient recruitment and management, sample collection & supporting team with data query resolution, reviewing protocol amendments, providing patient-centred insights to the research delivery team by supporting both the patients and the team through all aspects of the translational research portfolio in the melanoma research team. 

 

With support from the team the CRP will ensure that the safety and well being of the patients is maintained within the requirement of the multi-regulatory frameworks for clinical research ensuring compliance with ICH/GCP standards and Trust SOPs.

 

The successful candidate will be involved in raising the profile of the clinical research within the trust by engaging in promotional events relating to clinical research with attendance and contributions at local, national and international meetings.

 

Demonstrate awareness and contribution to divisional, Trust and national objectives and strategies.

Working for our organisation

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.

Detailed job description and main responsibilities

DUTIES AND RESPONSIBILITIES

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.

KEY VALUES

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

Person specification

Qualifications

Essential criteria
  • Diploma or relevant experience
Desirable criteria
  • A research qualification / clinical research training
  • Degree in science or health-related discipline
  • National Care certificate (Christie Care Certificate)

Experience

Essential criteria
  • Experience of working in a research environment Or At least 12 months working in a healthcare environment
Desirable criteria
  • Data management experience Clinical research experience, phlebotomy skills

Skills

Essential criteria
  • IT skills. Experience of using Email, Excel, Word and Outlook
Desirable criteria
  • Evidence of IT training Intra-venous access training, or a willingness to undertake this

Knowledge

Essential criteria
  • Awareness of ICH “Good Clinical Practice”.
  • Knowledge and understanding of patient observations
Desirable criteria
  • Knowledge of the clinical trial process.
  • Understanding of medical terminology and cancer
  • Knowledge of patient information systems

Values

Essential criteria
  • Ability to demonstrate the organisational values and behaviours

Other

Essential criteria
  • 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

Employer certification / accreditation badges

Veteran AwareApprenticeships logoNo smoking policyAge positiveMindful employer.  Being positive about mental health.Disability confident employer

Applicant requirements

This post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service.

Documents to download

Apply online now

Further details / informal visits contact

Name
Sharon Woolley
Job title
Research Team Leader
Email address
[email protected]
Telephone number
0161 918 7478
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