About this role
Job summary
The post holder supports and coordinates the GCP compliant setup, delivery and close down of a portfolio of research studies across the Diabetes and Endocrine, PAIN, Neurology and Ophthalmology, ensuring teams are supported to setup and deliver studies in a timely manner by providing appropriate governance oversight of the portfolio.
Following supporting the setup of studies, the research nurse will facilitate and aid recruitment of patients. The role will include identifying, consenting and following up suitable patients for clinical research working autonomously within professional practice guidelines and within the Research Governance Framework.
Main duties of the job
The post holder will take responsibility for the safe administration of experimental therapies, and for monitoring the expected and unexpected side effects of drugs and other treatment modalities used in these trials.
The post holder will manage a caseload of participants across Diabetes and Endocrine, PAIN, Neurology and Ophthalmology where needed. They will have duty of care in supporting them and their families throughout their participation in any research activity. They will also act as a patient advocate providing support and oversight as required. In addition, the research nurse will coordinate the portfolio of clinical research studies supporting and have oversight of the study set up, delivery (including data collection and site file maintenance) study close down and archiving.
The post holder will play a key role in ensuring that any research is undertaken within the departments safeguards the wellbeing of the patients and is conducted according to Good Clinical Practice (GCP) and the Medicines for Human Use (Clinical Trial) Regulations 2004 and Amended Regulations 2006.
About us
They will work across Diabetes and Endocrine, PAIN, Neurology and Ophthalmology where needed, to support teams to ensure the successful working of the clinical research projects they are assigned to. Where needed, they will supervise and mentor other staff, acting as line manager, whilst actively contributing to evaluation and improvement of the service.
In conjunction with the other members of the team, they will facilitate the production of good quality of research.
The post holder will work onsite and expected to work across Guy's Hospital, St Thomas' Hospital and in the community clinics as needed.
Job description Job responsibilities
Duties and Responsibilities
Clinical and Communication Responsibilities
Manage a caseload of participants acting as a professional in ensuring a duty of care to the participant and their families. Work within relevant regulations and ICH GCP (International Conference on Harmonisation and Good Clinical Practice), Trusts policies, research governance, Medicines for Human Use (Clinical Trials Regulations) Regulations, Data Protection Act and Human Tissue Act. ensuring that the clinical trial protocol is adhered to at all times. Devise, implement and evaluate strategies for identifying eligible participants for research studies, including by attending clinics, departments, screening notes/consultant referral and Multidisciplinary Team (MDT) meetings. Participate in the informed consent process acting as a resource and support to participants and their families. For appropriate studies take informed consent and ensure on-going consent in accordance with the necessary Trust research governance arrangements and necessary competent regulatory authority Regulations and International Conference on Harmonisation of Good Clinical Practice (ICH GCP)
Person Specification
Education/ Qualifications Essential
Level 1 Registered Nurse NMC (Adult or RSCN) Registration with previous acute NHS experience Educated to degree level or above GCP certificate
Desirable
A Clinical Research qualification ILS certificate
Previous experience Essential
Extensive experience of working within the NHS as a qualified nurse Experience with accessing and managing research data, databases, and Excel Spreadsheets Experience in coordinating the setup and delivery of Clinical Research in NHS
Desirable
Experienced and competent in the management of patients within the speciality Line management experience
Skills/Knowledge/ Ability Essential
Competency in Venepuncture, cannulation, medication administration including IV drugs and IV infusions IT skills including use of email and office packages. Ability to lead, teach, supervise and mentor others in all aspects of clinical research delivery. Excellent written and oral communication skills with ability to deal with complex and sensitive situations
Desirable
Ability to perform clinical activities specific to speciality Proficient with basic laboratory skills and able to mentor others
Physical Requirements Essential
Willingness and ability to travel across sites to work with teams and attend external meetings within the context of this post
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 (Opens in a new tab).
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 (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).
Employer details Employer name Guy's and St Thomas' NHS Foundation Trust
Address Guy's and St Thomas'
London
SE1 9RT
United Kingdom
Employer's website https://www.guysandstthomas.nhs.uk/careers/careers.aspx (Opens in a new tab)