Job summary
Are you dynamic, patient-centred and looking for an exciting challenge?

Why not consider joining the NIHR Clinical Research Facility (CRF) at Guy's and St. Thomas' NHS Foundation Trust?

We have a fantastic opportunity for two Band 6 nurses to start or continue developing their clinical research skills. Previous experience of clinical research projects and SACT competency is desirable. You will need to be a team player and effective at managing your own time.

The role is a combination of clinical and research responsibilities delivered within a diverse research portfolio. You will be a point of contact for study principal investigators, sponsors and patients. This means effective communication and team working skills are essential.

To meet the needs of the service you will be required to work at two of our Units - the Guy's Phase I Unit and the St. Thomas' Research Facility.

Your work patterns will be agreed with your Line Manager. You will be expected to work the shift patterns necessary to ensure patient safety and delivery of clinical trials. Work patterns will include mostly day shifts, with occasional early/late shifts, and some nights and weekends as required.

Main duties of the job
Assess, plan, implement, and evaluate expert research nursing care and provide support to patients attending the Department who have been or have the potential to be recruited onto a clinical trial programme. The Research Nurse will play a key role in ensuring that any research undertaken within the department safeguards the well being 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. In conjunction with the other members of the team, facilitate the production of good quality of research.

The research nurse will facilitate and aid in the recruitment of patients to ensure high quality clinical studies and trials which will require the nurse to work flexibly across the disciplines to ensure the successful working of the clinical research facility. They will also act as a patient advocate providing support and assistance as required and assist in the co-ordination and management of a portfolio of early phase translational clinical research.

The post holder will take responsibility for supervising 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.

About us
The National Institute of Health Research (NIHR) Clinical Research Facility (CRF) for Experimental Medicine at Guy's and St Thomas' NHS Foundation Trust provides state of the art facilitates and world-leading expertise to support the NHS, universities and industry in conducting groundbreaking experimental medicine studies.

The R&D Department employs a range of senior managers, technical managers, researchers, research support staff, research nurses and administrative staff. Based in the Tower Wing at Guy's Hospital, this diverse department has the breadth of knowledge and skills to ensure that this high level of research activity and associated research processes are managed smoothly, efficiently and collaboratively.

The Clinical Research Facility is comprised of five units located at our sites at Guys, St. Thomas' and the Royal Brompton.

With MHRA Phase I accreditation for our Guy's CRF unit, we are uniquely placed to deliver Phase I commercial and non-commercial patient focused studies. Our CRF is the only one in the UK with embedded Advanced Therapies Manufacturing (GMP) and immune monitoring platforms.

Job responsibilities
Clinical

• Carry out planned care required by the clinical trials protocol for a group of volunteers without direct supervision.
• Ensure the assessment, planning, implementation and evaluation of evidence based, individualized patient/volunteer care.
• Responsible for recruiting to, and following up, patients within studies. This includes both randomized clinical trials and other high quality clinical studies. The role will involve working closely with multidisciplinary clinical teams
• Act as a patient advocate enabling patients to make informed choices concerning their involvement in the clinical trials and ensuring advice and information is provided.
• Ensure there is sufficient skill mix of staff for patient safety during clinical trials and ensuring that they are carried out within the Trust and Centre's policies and clinical trial protocol.
• Assist in clinical trials including venepuncture and cannulation of volunteers when necessary ensuring that they are carried out within the Trusts policies, research governance , Medicines for Human Use ( Clinical Trials Regulations ) Incorporating International Conference on Harmonisation of Good Clinical Practice (ICH GCP) and Data Protection Act.
• Undertake clinical tasks such as phlebotomy, analysis of blood specimens, drug administration and clinical observation etc. Assist and advise staff, both registered and unregistered in the delivery of care to the volunteer.
• Ensure that written informed consent has always been obtained for any treatment provided for, or any sample or data taken from a Volunteer which will form part of a research study , in accordance with the Trust research governance arrangements and Medicines for Human Use ( Clinical Trials Regulations ) Incorporating International Conference on Harmonisation of Good Clinical Practice (ICH GCP).
• Have responsibility for the correct administration and custody of medicines according to Trust policy.
• Maintain all data and case report forms relating to clinical trials in accordance with the Medicines for Human Use ( Clinical Trials Regulations ) Incorporating International Conference on Harmonisation of Good Clinical Practice (ICH GCP). Report any deviation from normal practice to senior staff and implement agreed changes in care programme.
• Deal with concerns raised by volunteers and visitors in a proactive manner and take remedial action as necessary.
• Act as the volunteers advocate

Administration

• Plan, organize and deploy staff according to ability and workload in order to meet participant needs.
• Ensure that nursing practices comply with Trust policies and procedures
• Communicate effectively at all times and maintain a harmonious working environment.
• Maintain a safe environment in accordance with the Health and Safety at Work Act.
• Assist the Nurse Manager in managing incidents, accidents and complaints in accordance with Trust policies and procedures. Assist in ensuring the availability of resources for volunteer care. Ensure equipment is in good working order, and report appropriately when defective
• Participate in audits, Eg. those undertaken by the Medicines and Health Care Regulatory Authority ( MHRA ), nursing audits and clinical benchmarking exercises, and suggest any change to improve standards
• Ensure the economical use of resources
• Contribute to the overall control of the ward or departmental budget and identify areas where cost improvements can be made.
• Ensure the safe custody of volunteers property in accordance with Trust policies.
• Actively participate in and support the development of the clinical research facility.
• Promote and participate in the implementation of policies within the Centre and to ensure compliance with Trust, Government and EU Directives.
• Maintain accurate documentation in clinical trial documents and patient notes.
• Ensure that clinical trials are effectively archived as required. Assist in the process of gaining local regulatory committee approval (ethics and R&D approval).

Education and Training

• Assist in the education and support of health care professionals to enable them to care for clinical trial patients and recruit to clinical trials where appropriate.
• Maintain an up to date knowledge of research related topics particularly related to clinical trials.
• Attend local and national meetings as appropriate and as agreed with the local coordination centre.
• Attend regular update sessions at GSTT.
• Assess the needs of volunteers, relatives and carers and provide them with information as requested
• Educate and counsel volunteers, family and those who volunteer for clinical trials before, during and after clinical studies and investigations
• Assist the Charge Nurse in orientating all new staff and students to the ward or department
• Provide teaching and development to the nursing team and students helping them to achieve their learning outcomes
• Act as a role model, mentor and preceptor to the nursing team

Other

• Understand and adhere to Trust policies and procedures. To maintain patient confidentiality and standards of Good Clinical
• Practice (GCP) at all times
• Maintain NMC registration

Person Specification
Knowledge/Qualifications
Essential

• Level 1 NMC Registered Nurse
• Educated to degree Level or above

Desirable

• Specific Clinical Research qualification
• Relevant specialist course or equivalent experience (eg. SACT)

Previous Experience
Essential

• Extensive experience of working within a ward environment as a qualified nurse
• Experience with data management including Excel Spreadsheets, eCRF and patient database systems
• Experience of effective multidisciplinary team working
• Familiar with Good Clinical Practice & Certification

Desirable

• Post registration experience in a relevant specialty (SACT, oncology, research delivery)

Skills
Essential

• Knowledge of research methodologies
• Knowledge of quality, standard setting, benchmarking and audit
• Competency in medication administration including IV drugs
• Organisation, problem solving and management skills
• Ability to perform clinical activities specific to speciality
• Competency in phlebotomy and cannulation

Additional Information
Essential

• Flexible approach towards teamwork and patient/family involvement
• Enthusiastic, professional and accountable

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.

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).

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).