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Clinical Research Nurse
4 months ago
Job overview
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 be responsible for research studies conducted within the Diabetes & Endocrine and Adult Inherited Metabolic Disease, and sometimes, required to support studies in Nutrition and Dietetics and Neurology.
Main duties of the job
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 projects they are assigned to. 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 clinical research studies.
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.
Working for our organisation
Diabetes & Endocrine and Adult Inherited Metabolic Disease department sits within the Medical Specialties. The research team is integrated into the unit and we have the opportunity to recruit patients directly from the clinic. The research team is made up of Principal Investigators, research nurses, clinical research practitioners and clinical research dietitians. The team works across both Guy’s and St Thomas’ hospitals including the community sites.
Detailed job description and main responsibilities
Duties and ResponsibilitiesClinical and Patient care
Ensure the assessment, planning, implementation and evaluation of evidence based, individualised patient/volunteer care. Ensure that patients receive high quality clinical care and a good patient experience, having regard for their customs, religious beliefs and doctrines. Carry out planned care as required by the clinical trial/study protocol without direct supervision. Responsible for setting up and recruiting to, and following up, patients within studies. This includes both randomised clinical trials and other high quality clinical studies. The role will involve working closely with multidisciplinary clinical teams. Act as a patient/volunteer 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/volunteer safety during clinical trials and ensuring that they are carried out within the Trust and Centre's policies and clinical trial protocols. Assist in all clinical aspects of clinical trials including venepuncture, cannulation blood sample processing, drug administration and clinical observation when necessary ensuring that they are carried out within the Trust’s policies, research governance, Medicines for Human Use (Clinical Trials Regulations) Regulations 2004 and Amended Regulations 2006 Incorporating International Conference on Harmonisation of Good Clinical Practice (ICH GCP) Data Protection Act and Human Tissue Act. Assist and advise research and clinical staff, both registered and unregistered in the delivery of care to the volunteer. Ensure that written informed consent is obtained from every study subject before any study related procedure/s are carried out; including sample or data collection, administration of treatment or clinical observation, drug administration and clinical observation. This is in accordance with the Trust research governance arrangements and Medicines for Human Use (Clinical Trials Regulations) Regulations 2004 and Amended Regulations 2006 incorporating International Conference on Harmonisation of Good Clinical Practice (ICH GCP) Is wholly accountable for his / her practice in line with the NMC code of professional conduct and takes every reasonable opportunity to sustain and improve his / her knowledge and professional competence related to their specific part of the NMC register. Have responsibility for the correct administration and custody of medicines according to Trust policy. Record accurately all data obtained throughout a research study and maintain all data and case report forms, both paper and electronic, relating to clinical trials in accordance with the Medicines for Human Use (Clinical Trials Regulations) Regulations 2004 and Amended Regulations 2006 Incorporating International Conference on Harmonisation of Good Clinical Practice (ICH GCP) and the Research Governance Framework. 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. To be an effective communicator with patients/carers/families regarding receiving treatment and management (CLINICAL JD) as part of a research study.Quality
Facilitate a high quality, cost effective specialist service through monitoring and audit and other quality initiatives agreed by the trust. Lead on and participate in key developments relating to the speciality so that high quality patient focused care is promoted. Provide support to set, monitor and review standards of care on a regular basis and initiate corrective action plans where required. Identify and intervene where circumstances contribute to an unsafe environment for patients and staff. To bring such instances to the attention of the Lead Clinical Research Nurse/ Research, Senior Clinical Nurse or Research nursing team.Administration
Plan, organise and deploy staff according to ability and workload in order to meet patient/volunteer 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 Lead Clinical Research Nurse 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/inspections, those undertaken by the Medicines and Health Care Regulatory Authority (MHRA), quality control, 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 unit or departmental budget and identify areas where cost improvements can be made Ensure the safe custody of patient/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 department and to ensure compliance with Trust, Government and EU Directives. Maintain accurate documentation in clinical trial documents and patient notes. Ensure that clinical trial/research study data 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. Be responsible for maintaining a Training folder and for keeping all mandatory training and research specific training up to date to support ongoing professional development and compliance with NMC revalidation requirements. 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 co-ordinating centre. Attend regular update sessions at GSTT including the Clinical Research Nurse and Midwife Forum. 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 Lead Clinical Research Nurse/ Research Team in orientating all new staff and students to the unit or department Provide teaching and development to the nursing team and students helping them to achieve their learning outcomes. Contribute and assist the Lead Clinical Research Nurse/ Research Staff / Research Matron to foster a learning environment within the clinical area. 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 registrationNature and Scope of Job
Post holders will assist in recruiting patients to studies which have been adopted by the National Institute for Health Research (NIHR). They will work closely with the Lead Clinicians in the individual centres to which they are assigned, and with the coordinating centres and Principal Investigators across South London. They will attend co-ordinating centre meetings on a regular basis for study updates and meetings with the coordinating staff.
The post holder is required to follow Trust policies and procedures which are regularly updated including:
Person specification
Education/ Qualifications
Essential criteria
RN1 / RN2 Registered Nurse on the NMC Register Educated to degree level or above
Desirable criteria
Good Clinical Practice certificate Immediate Life Support Certificate
Previous experience
Essential criteria
Extensive experience of working within an acute adult patient setting as a qualified nurse with previous acute NHS experience Evidence of professional clinical or research knowledge in adult nursing Experience with a variety of computer programmes, including Access, Excel, Microsoft office, Outlook and databases
Desirable criteria
Experience in Clinical Research Experience of electronic data capture
Skills/Knowledge/ Ability
Essential criteria
Competency in medication administration including IV drugs. Proficient to conduct clinical tasks such as blood pressure, venepuncture and cannulation, serial sampling, temperature, pulse, respiratory observations and ECG Organisation and management skills.
Desirable criteria
Knowledge of research methodologiesGuy’s and St Thomas’ celebrates, respects and values the diversity of its staff and patients. We review our policies, procedures and practices to ensure that all employees, patients and carers are treated equitable according to their needs. We are actively committed to ensuring that no one who applies for a job, works or study’s at the Trust, or accesses our services is discriminated against on the grounds of race, ethnicity, nationality, disability, religion or belief, age, gender identity , gender reassignment, sexual orientation, pregnancy and maternity/paternity, or marital/civil partnership.
