Job summary
The Clinical Research Nurse will play a key role in ensuring that any research undertaken within the department 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. In conjunction with the other members of the team, you'll facilitate the delivery of high quality research. This will be a challenging and varied position involving extensive coordination and communication within internal and external stakeholders. The post holder will provide strong administration and clinical skills within the team. In addition to recruitment and delivery of trial interventions, the post holder will be responsible for proactively managing trials as determined by the team, reporting on trial progress and building relationships and communications as required. This post is currently a 12 month, fixed term contract due to short term funding.
Main duties of the job
The post holder will facilitate and aid in the recruitment of patients to ensure high quality clinical studies and trials which will require them 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. The post holder will actively participate in any development relating to the departmental objectives.
About us
Our Research team support studies across the Surgical Oncology Directorate which comprises breast, head and neck, thoracic surgery, ear, nose and throat, audiology, and gynae-oncology. You will be based in a team that primarily support the delivery of commercial and non-commercial research studies in Head and Neck (H&N) services; Ears, Nose and Throat (ENT) services and Audiology services.
The core ENT research team, that you will be central to and line managed within is by our lead research nurse and based in our ENT outpatient's department at Guy's Hospital, where you will be primarily based. You'll be working together with the team to support our research colleagues across ENT, H&N, Audiology and sometimes more broadly should this be required, so travel to St Thomas' Hospital might also be necessary. Our teams deliver an exciting and varied research portfolio involving both commercial and non commercial research studies and hosted and sponsored studies. The studies range from first in man and novel implantable device studies to observational and data collection studies offering lots of opportunities to learn new skills and be at the cutting edge of new techniques being trialled within the NHS.
Job description
Job responsibilities
Clinical Provide excellent customer care skills to ensure patients and participants come first. Work within relevant regulations and ICH GCP (International Conference on Harmonisation and Good Clinical Practice) ensuring that the clinical trial protocol is adhered to at all times. Devise, implement and evaluate strategies for recruiting participants into clinical studies and identify individuals potentially eligible for research studies. For specific studies post holder may be delegated to obtain consent from participants in line with Trust policy and research protocol. Organise and facilitate participant appointments and follow-up phone calls. Accurately perform and record observations of clinical activities required according to personal competencies and the study protocol and obtain the results including blood pressure, temperature, respirations, questionnaires, urinalysis, weight and height, and report abnormalities or changes appropriately. Report any adverse events or health concerns which occur whilst the participant is taking part in the study to the appropriate doctor or nurse in a timely manner, and to the appropriate principal or coinvestigator. Liaise with pharmacy to co-ordinate the availability and dispensing of study drugs if appropriate. Perform tasks requiring clinical and laboratory skills, including phlebotomy, venepuncture, tissue and blood sample preparation within clinic and laboratory in line with personal competencies and approved study protocol. Process biological samples according to personal competencies and the study-specific protocol and laboratory manual and organise the storage, shipment and documentation of samples. Provide ongoing support to the participant and carer whilst participating in the clinical study. Communicate study related information effectively with the research team and study participants and their family members. This information may be complex or sensitive, and there may be barriers to understanding. Engage effectively with other departments and wards at the site/s, in order to promote a good working environment, integration of research and open channels of communication. Communicate with internal and external study coordinators and sponsor representatives, nationally and internationally. Attend and participate in multidisciplinary team meetings. Arrange, attend and record minutes for research and other relevant departmental meeting. Attend national and international study specific meetings and disseminate information to members of the multi-disciplinary team as required. 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. Undertake clinical tasks such as drug administration and clinical observation. Have responsibility, under supervision, for the correct administration and custody of medicines according to Trust policy. Deals with telephone queries from patients, relatives and their carers. Refer queries to other members of the multidisciplinary team as required and act in accordance with team practices. Complies with the informed consent process as described in the approved protocol, including use of approved versions of the patient information sheet, 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) Recognises that informed consent is an ongoing process and demonstrates awareness of the factors contributing to a participants autonomous decision making during the consent process. Recognises own learning needs and takes responsibility for maintaining up to date knowledge. Facilitate a high quality, cost effective specialist service through monitoring and audit and other quality initiatives agreed by the trust. 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 senior team members e.g. lead research nurse, research manager or CRF Nurse Manager. Administration Ensure that clinical 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 Manager in managing incidents, accidents and complaints in accordance with Trust policies and procedures. Ensure equipment is in good working order, and report appropriately when defective Participate in audits/inspections, e.g. 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 Ensure the safe custody of patient/volunteers property in accordance with Trust policies. Actively participate in and support the development of the research environment. 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); when required. To ensure compliance within the team is adhered to with regards to the Trusts policy on data protection, confidentiality and security. To ensure that all data added to the electronic database is accurate and complete. 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. 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 Research Manager and team in orientating all new staff and students to the unit or department; where appropriate. Contribute and assist the team to foster a learning environment within the clinical area; where appropriate. Act as a role model, mentor and preceptor to the research 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 Undertaking any other duties that may be required from time to time as are consistent with the responsibilities of the grade and the needs of the service.
Job description
Job responsibilities
Clinical Provide excellent customer care skills to ensure patients and participants come first. Work within relevant regulations and ICH GCP (International Conference on Harmonisation and Good Clinical Practice) ensuring that the clinical trial protocol is adhered to at all times. Devise, implement and evaluate strategies for recruiting participants into clinical studies and identify individuals potentially eligible for research studies. For specific studies post holder may be delegated to obtain consent from participants in line with Trust policy and research protocol. Organise and facilitate participant appointments and follow-up phone calls. Accurately perform and record observations of clinical activities required according to personal competencies and the study protocol and obtain the results including blood pressure, temperature, respirations, questionnaires, urinalysis, weight and height, and report abnormalities or changes appropriately. Report any adverse events or health concerns which occur whilst the participant is taking part in the study to the appropriate doctor or nurse in a timely manner, and to the appropriate principal or coinvestigator. Liaise with pharmacy to co-ordinate the availability and dispensing of study drugs if appropriate. Perform tasks requiring clinical and laboratory skills, including phlebotomy, venepuncture, tissue and blood sample preparation within clinic and laboratory in line with personal competencies and approved study protocol. Process biological samples according to personal competencies and the study-specific protocol and laboratory manual and organise the storage, shipment and documentation of samples. Provide ongoing support to the participant and carer whilst participating in the clinical study. Communicate study related information effectively with the research team and study participants and their family members. This information may be complex or sensitive, and there may be barriers to understanding. Engage effectively with other departments and wards at the site/s, in order to promote a good working environment, integration of research and open channels of communication. Communicate with internal and external study coordinators and sponsor representatives, nationally and internationally. Attend and participate in multidisciplinary team meetings. Arrange, attend and record minutes for research and other relevant departmental meeting. Attend national and international study specific meetings and disseminate information to members of the multi-disciplinary team as required. 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. Undertake clinical tasks such as drug administration and clinical observation. Have responsibility, under supervision, for the correct administration and custody of medicines according to Trust policy. Deals with telephone queries from patients, relatives and their carers. Refer queries to other members of the multidisciplinary team as required and act in accordance with team practices. Complies with the informed consent process as described in the approved protocol, including use of approved versions of the patient information sheet, 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) Recognises that informed consent is an ongoing process and demonstrates awareness of the factors contributing to a participants autonomous decision making during the consent process. Recognises own learning needs and takes responsibility for maintaining up to date knowledge. Facilitate a high quality, cost effective specialist service through monitoring and audit and other quality initiatives agreed by the trust. 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 senior team members e.g. lead research nurse, research manager or CRF Nurse Manager. Administration Ensure that clinical 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 Manager in managing incidents, accidents and complaints in accordance with Trust policies and procedures. Ensure equipment is in good working order, and report appropriately when defective Participate in audits/inspections, e.g. 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 Ensure the safe custody of patient/volunteers property in accordance with Trust policies. Actively participate in and support the development of the research environment. 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); when required. To ensure compliance within the team is adhered to with regards to the Trusts policy on data protection, confidentiality and security. To ensure that all data added to the electronic database is accurate and complete. 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. 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 Research Manager and team in orientating all new staff and students to the unit or department; where appropriate. Contribute and assist the team to foster a learning environment within the clinical area; where appropriate. Act as a role model, mentor and preceptor to the research 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 Undertaking any other duties that may be required from time to time as are consistent with the responsibilities of the grade and the needs of the service.
Person Specification
Professional/Statutory Registration, Qualifications and Education
Essential
- NMC Level One Registration - RN Adult
- Evidence of continued personal, professional and academic development
Desirable
- Relevant post registration qualification
- Basic knowledge of recent NHS Legislation and recommendations
Previous experience
Essential
- Introductory experience in relevant setting
- Knowledge of clinical pathways and systems
- Excellent computer literacy (microsoft word and excel, databases, email)
Desirable
- Experience in research methodologies
Skills/Knowledge/Ability
Essential
- Excellent communication and interpersonal skills
- Accuracy and attention to detail in data collection
- Ability to work autonomously and as a member of a small team as well as wider multidisciplinary team
- Ability to work across boundaries, integrating with multidisciplinary staff in relation to clinical trials
Desirable
- Word processing, report writing and presentation skills
Additional information
Essential
- Ability to organise, prioritise and coordinate work of self and others
- Commitment to achieving objectives of the research team
- Strong motivation to work within the field of research
Desirable
- Innovative and responsive to change
Physical Requirements
Essential
Person Specification
Professional/Statutory Registration, Qualifications and Education
Essential
- NMC Level One Registration - RN Adult
- Evidence of continued personal, professional and academic development
Desirable
- Relevant post registration qualification
- Basic knowledge of recent NHS Legislation and recommendations
Previous experience
Essential
- Introductory experience in relevant setting
- Knowledge of clinical pathways and systems
- Excellent computer literacy (microsoft word and excel, databases, email)
Desirable
- Experience in research methodologies
Skills/Knowledge/Ability
Essential
- Excellent communication and interpersonal skills
- Accuracy and attention to detail in data collection
- Ability to work autonomously and as a member of a small team as well as wider multidisciplinary team
- Ability to work across boundaries, integrating with multidisciplinary staff in relation to clinical trials
Desirable
- Word processing, report writing and presentation skills
Additional information
Essential
- Ability to organise, prioritise and coordinate work of self and others
- Commitment to achieving objectives of the research team
- Strong motivation to work within the field of research
Desirable
- Innovative and responsive to change
Physical Requirements
Essential
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.
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).
Additional information
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.
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).
