Clinical Research Nurse - Cancer Research UK Clinical Trials Unit

University of Birmingham

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Town/City:

Birmingham


Position type:

Full time


Salary:

£30,942 - £42,792

16 Mar 2020
30 Mar 2020

Full details:

Reference number: BIR-200001F7

Position Details

Cancer Research UK Clinical Trials Unit

Location: University of Birmingham, Edgbaston, Birmingham UK

Full time starting salary is normally in the range £30,942 to £40,322, with potential progression once in post to £42,792.

Grade 7

Full Time / Fixed Term Contract to 31 December 2022

Closing date 30 March 2020

 

Role Summary

This specialist research nurse role is to support the delivery of clinical trials within the early phase oncology and haematology trials teams.

The post holder will be responsible for the delivery of direct and indirect care and safe nursing practices for a specific group of patients taking part in predominantly phase I/II clinical trials but may at times involve phase III clinical trials. The post holder will be required to administer novel immunotherapy and cytotoxic agents and for the collection of pharmacokinetic and pharmacodynamics samples. The role will require an expanded practice of clinical research process knowledge. The post holder will work both as a clinical site team member and, as a senior member of staff, contribute to the conduct and coordination of Cancer Research UK Clinical Trials Unit (CRCTU) early phase clinical trials.

The post holder will work alongside an existing team of Clinical Research Nurses within the CRCTU and at times provide cross cover between the oncology and haematology nursing teams.

 

Main Duties and Responsibilities

Clinical Duties

  • Practice at all times within the Nursing and Midwifery Code of Professional Conduct – maintaining registration and post registration education and practice (PREP) requirements and accountable for professional actions, identify on-going personal and professional development needs and maintaining up-to-date clinical skills and knowledge required for delivering care to research patients
  • Take on duties delegated by the site Principal Investigator (PI) as applicable to the job role and training received ensuring junior members of the nursing team fulfil their appropriate roles
  • Conduct and lead on the planning of clinical study assessments and treat the patient as delegated and in accordance with the protocol as the lead designated nurse for the identified clinical trial
  • To cannulate and administer intravenous novel cytotoxic or immunotherapy agents and/or intravenous, intramuscular and sub cutaneous drugs or administer oral/topical agents according to protocol
  • Develop specialist expanded practice skills within the University Hospital Birmingham NHS Foundation Trust and act as a senior member of the nursing team to ensure junior nursing staff are trained and signed onto the expanded practice register to fulfil skills such as cannulation, phlebotomy, IV therapy and ECG’s
  • To collect blood samples as required for pharmacokinetic, pharmacogenetics, pharmacogenomics, proteomics, metabolics and pharmacodynamics studies
  • Subsequent preparation, processing and storage of the above samples meeting the necessary requirements required by study protocols ensuring the clinical area is compliant with good laboratory practice for sample preparation as guided by the National Institute of Health Research Wellcome Clinical Research Facility (NIHR WTCRF) at the UHBFT
  • Co-ordinate and maintain adequate records of all clinic visits, admissions and investigations required by study protocols and assist junior members of the nursing team when allocated as a second nurse to mentor on allocated clinical trials
  • Instruct patients and their carer’s in any specialised procedures, safety requirements and responsibilities of trial participation acting as a role model on patient advocacy for the nursing team
  • Work alongside the other Senior Clinical Research Nurses within the CRCTU to prioritise own workload and to ensure that the interests of the research subjects are met
  • Day to day supervision of junior clinical research nursing team members, assist in the induction and orientation of new staff
  • Identify areas affecting the delivery of recruitment, compliance, safety and timely data return etc and work with CR UK Senior Research Nurse to provide solutions
  • Provide out of hours nursing cover when required and on an ad hoc basis

 

Research Duties

  • Conduct clinical research in accordance with Good Clinical Practice (GCP), the Declaration of Helsinki, applicable regulations (including the Medicines for Human Use Clinical Trials Regulations, Data Protection Act 1998, Human Tissue Act etc) the Research Governance Framework for Health and Social Care and Caldicott principals in order to protect the research subject and the quality of each study
  • As a senior member of the CRCTU nursing team provide specialist nursing advice and review CRCTU research protocols, patient information sheets etc as and when required act as a clinical research nurse advisor to the CRCTU on existing clinical trial protocols to examine and discuss possible recruitment strategies to aid other local sites and share best practice
  • Highlight research opportunities for independent research or for collaborative nurse led research projects
  • Identify, screen and participate in valid informed consent process of subjects into research studies according to the protocol defined inclusion and exclusion criteria, leading on the informed consent process with the clinical team
  • Participate in clinical trial monitoring internally and externally as required in order to meet the governance requirements of each study, working closely with the monitoring team within the CRCTU to maintain an up-to date knowledge on requirements
  • Participate in existing teaching programmes within the clinical area and the CRCTU as appropriate, identifying gaps to develop education sessions for staff
  • Demonstrate a high level of accuracy in general administration and management of data being transcribed into case report forms, UHBFT patient record systems, pharmaceutical industry representatives and other research institutions
  • As appropriate assist in organisation of (and attend) investigator meetings for studies within the team’s portfolio

Governance Duties

  • Provide advice and support to other members of the multidisciplinary research and clinical teams with regard to GCP and research governance requirements, project development, implementation and completion for each study in order to ensure the safe and accurate conduct of clinical research
  • On behalf of the PI report adverse events and serious adverse events in accordance with the approved protocol, in a timely and effective manner. Report at a local level in accordance with relevant University Hospital NHS Foundation Trust (UHBFT) procedure
  • Ensure that clinical trials are undertaken in accordance with the approved protocol and in accordance with CRCTU, NHS Research and Development (R&D) Office approval
  • Participate and maintain up-to date records within the UHBFT mandatory training programme, University of Birmingham Mandatory Training and the CRCTU Quality Management System

 

Person Specification

  • First level Registered General Nurse with relevant extensive oncology or haematology experience and able to demonstrate the appropriate competencies and skills for the job and clinical setting
  • Agenda for change at band 6 or relevant experience demonstrating the appropriate competencies and skills for the job within a clinical setting
  • A relevant qualification in the administration of Anti-Cancer Drug Therapies (or equivalent), ENB998 or equivalent , relevant oncology or haematology nursing qualification – demonstrated at a degree level or willing to obtain at degree level
  • Excellent skills (or willing to train) in the following: cannulation, phlebotomy, ECG, ability to assess the patient and refer onto relevant agencies, administration of cytotoxic medicines, preparation, processing and storage of blood samples according to study protocol
  • Demonstrable experience in mentoring and motivating junior members of a team, ensuring a strong team working ethic
  • Ability to communicate with patients, family and friends to assess needs and act as patient advocate to provide relevant support, information, education and advice where and when necessary, with easy access to support and supervision from Senior Clinical Research Nurses and associated medical staff
  • Demonstrable negotiation skills and the ability to work independently and unsupervised within a multi-disciplinary team, this will include effective listening and interpersonal skills, time management skills and the ability to prioritise own workload and ability to work using own initiative
  • Computer literate with a critical and intelligent attention to detail and high standards of accuracy
  • Flexible approach to time management, being able to plan ahead and deal with emergencies as they arise the study protocol

The University is committed to safeguarding and we promote safe recruitment practice, therefore all associated pre-employment checks will be undertaken before any appointment is confirmed. Due to the nature of the work undertaken in this role all successful applicants will be subject to a satisfactory Occupational Health and/or DBS clearance prior to appointment.

Further particulars can be found here: http://www.download.bham.ac.uk/vacancies/jd/MDSFPs.pdf

Informal enquiries can be made to Karen Turner at K.Turner.1@bham.ac.uk

 

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