Are you interested in Research?
Lewisham and Greenwich NHS Trust is a research-active organisation with a proven track-record in clinical research. We are committed to developing our research portfolio and to enable this we are strengthening our research infrastructure.
This role involves working cross-site at University Hospital Lewisham and Queen Elizabeth Hospital, Woolwich and the successful candidate would be managed jointly between the Paediatric and R& D teams.
We are currently looking for a nurse with an interest in Children's research to be part of our team in Children's Services to coordinate the multiple research studies that we have enrolled in alongside the Consultant with an interest in research and the research department.
You will be a part of a friendly, passionate and supportive Research and Development team working together to support the delivery of NIHR portfolio studies and Commercial research studies. It is important that the applicant is self-motivated and has a keen interest in clinical research. Prior experience of working in paediatrics is essential for this role but having research experience is desirable.
Previous applicants need not apply.
The role involves working closely alongside the multi-disciplinary team and the research participants and their families. Central to the role is recruitment- undertaking all aspects of a clinical research trial including screening and assessing patient eligibility for the trial, obtaining informed consent, carrying out study procedures, entering study data, undertaking study follow ups in accordance with study protocol. The successful applicant will be responsible for ensuring that any research undertaken within the department safeguards the well-being of the patients and is conducted within ICH Good Clinical Practice Guidelines for Research.
The post holder will: be responsible for the day to day management of a portfolio of studies at the Trust, work with colleagues to promote and facilitate research activity within the trust support the R&D Delivery Manager in achieving the team objectives to develop and extend the range of research undertaken support and supervise the trust Clinical Trial Co-ordinators and work with the network delivery staff Work with colleagues to implement the recruitment plans
Key Result Area 1 Service Management:
Support the R&D Delivery Manager in delivery of recruitment into clinical trials, including assisting investigators to determine recruitment targets during study set-up and feasibility assessment
Evaluate clinical trial protocols in close liaison with Principal Investigators and research managers, identifying implications for service support, changes in treatment and completing feasibility assessments
Develop and maintain relationships with the trust staff in Service Support departments ( e.g. Pharmacy, Radiology and Laboratory services)
Ensure a study site master file is set up and properly maintained for each trial
Identify patients suitable for entry into trials by attending clinics, screening notes, attending multi-disciplinary team meetings and using clinical databases
Ensure patients are fully informed prior to entry in any clinical trial and provide them with reassurance and support
Assist in consenting, randomising and allocating of treatment of patients
Collect biological samples e.g. blood required as part of the protocol and ensure safe and appropriate storage and shipment of specimens
Co-ordinate the accurate completion of Case Report Forms (CRFs) in conjunction with the Clinical Trial Co-ordinators
Assisting investigators in the timely completion of clinical research files and resolution of data queries
Ensure the study recruitment figures are reported weekly onto the EDGE database in accordance with local and national requirements
To supervise the patient follow-up process and provide supportive care
Support the trust in meeting national R&D standards including the Research Governance Framework, Good Clinical Practice (GCP), Information Governance, Data Protection Act etc;
Prioritise patient safety and the well-being of clinical trial participants at all times
Represent Research & Development and the trust at meetings with external organisations including sponsors and monitors as required
Develop plans and monitor trial recruitment and develop suitable interventions for under-recruiting studies;
Ensure that patient data is protected according to the Data Protection Act 1998
Support the R&D Delivery Manager in investigating any concerns around the conduct of clinical trials and escalating within the Senior Management team, Clinical Director and sponsor as appropriate