Job summary
Are you looking for a new challenge to progress your career within Transplant, renal and urology nursing? Do you think you could contribute to a busy and dynamic clinical research team? We are looking for an experienced and highly motivated research nurse to join our research team and lead on the delivery and development of our commercial research portfolio. You should have excellent communication and interpersonal skills and have the ability and initiative to work independently. You should be able to manage your workload flexibly across a range of projects and deadlines in a fast-paced and collaborative working environment. This is a role that requires high level of autonomy.
You will be supported by Head of Research workforce, R&D lead and a band 7 team lead and will have opportunity for professional development
Main duties of the job
You will be an essential member of the TRU research team, leading a growing portfolio of commercial clinical trials of investigational medicines & devices within this specialty. The role will include screening and recruiting potential participants, administering study medication, providing follow up care including safety monitoring, collecting and maintaining study records, organising, collecting & processing patient samples and liaising with principal investigators and clinical staff to ensure safe and high-quality care for our patients and service users.
You will work closely with principal investigators, clinicians, the wider research delivery team including the team lead and trial pharmacists to effectively deliver safe research care to eligible patients.
You will maintain oversight of our commercial trial portfolio and in conjunction with R&D lead and Principal Investigators work to grow the portfolio and build capacity.
About us
There are excellent opportunities for further education and research development as part of these roles, with access to CPD funding and revalidation support. Opportunities for developing new research and clinical skills are available and actively encouraged. The normal working hours are Monday to Friday 9am-5pm, although the post holder will need to be flexible to accommodate patient visits and assessments outside of these hours when required.
Job description
Job responsibilities
CLINICAL:
- Work autonomously to manage and coordinate own portfolio of clinical research whilst working as part of a multidisciplinary team. Maintaining effective communication with patients, carers and professionals to ensure service delivery. Assist in selecting, screening and organising the patients and/or volunteers suitable for entry into clinical trials/studies.
- Ensure patients are fully informed prior to entry in any clinical research programme and play a key role in eliciting informed consent to participate, and in randomising and allocating treatments.
- To provide ongoing advice and information to patients/volunteers with regards to their participation in clinical research in order to facilitate effective informed consent.
- Evaluate patient eligibility for clinical trials/studies entry, co-ordinating pre-study tests, obtaining results and arranging appropriate appointments according to the research protocol. Act as a resource and support to patients and their relatives, explaining practical aspects of the trial or study, assisting and supporting local nursing teams.
- Coordinate the collection of any biological samples required as part of the clinical trial/study and ensure safe and appropriate storage of specimens, in conjunction with local nursing teams.
- Ensure the safe administration of trial drugs, have in-depth knowledge of the legal requirements of a clinical trial sponsor regarding pharmacovigilance and of the Trust pharmacovigilance policy. Report any adverse events and reactions in accordance with this policy and the trial protocol.
- At all times to ensure clear, accurate records, developing data collection, case report forms and design of database where required for patient and staff records.
- Implement and adhere to the principles of Good Clinical Practice (GCP) and ensure that all trials are conducted according to the Medicines for Human Use (Clinical Trial) Regulations 2004 and Amended Regulations 2006 where appropriate.
- Liaising with the Joint Clinical Trials Office and Trusts R&D Offices relating to submission of the study for regulatory approval and Trust Management approval. Assist in completing submissions to the Research Ethics Committee as required.
- Perform tasks requiring highly developed clinical skills including phlebotomy, cannulation, etc and the administration of trial drugs, and to keep up to date with current practices for cannulation, phlebotomy etc,
- To oversee the routine maintenance and servicing of clinical equipment
MANAGEMENT:
- To act as clinical supervisor to junior research staff and act as a role model for excellence in clinical research.
- To represent Guys and St Thomas NHS Foundation Trust as an expert research nurse in external situations, for example national and international conferences, committees etc.
- To report any adverse incident/near misses in relation to that activity
- To facilitate and maintain effective communication within the clinical team.
- To responsibly manage the control of equipment, resources and stock through the adherence of research policies and clinical trials budgets.
EDUCATION:
- Ensure mandatory clinical trials training is undertaken and updated as required.
- To be responsible for developing and sustaining own knowledge, clinical skills and professional awareness.
PROFESSIONAL:
- You will be accountable for your own professional actions, and be a lead specialist for defined area acting within clearly defined policies/procedures and codes of conduct including the NMC code and Trust policy.
- To act in accordance with local policies and procedures laid down by Guys and St Thomas NHS Foundation Trust and ensure that all mandatory training for nursing staff within the Trust is attended.
- To work within the NMC Scope of Professional Practice and Code of Conduct.
- To undertake Performance Development Review annually to identify organisational and professional objectives and developmental needs.
- To keep up to date with departmental, Trust, NHS, academic and EU developments for the management of clinical research ensuring timely, effective implementation of changes.
- To attend courses as deemed relevant, including mandatory training, and to attend meetings and conferences as appropriate
Job description
Job responsibilities
CLINICAL:
- Work autonomously to manage and coordinate own portfolio of clinical research whilst working as part of a multidisciplinary team. Maintaining effective communication with patients, carers and professionals to ensure service delivery. Assist in selecting, screening and organising the patients and/or volunteers suitable for entry into clinical trials/studies.
- Ensure patients are fully informed prior to entry in any clinical research programme and play a key role in eliciting informed consent to participate, and in randomising and allocating treatments.
- To provide ongoing advice and information to patients/volunteers with regards to their participation in clinical research in order to facilitate effective informed consent.
- Evaluate patient eligibility for clinical trials/studies entry, co-ordinating pre-study tests, obtaining results and arranging appropriate appointments according to the research protocol. Act as a resource and support to patients and their relatives, explaining practical aspects of the trial or study, assisting and supporting local nursing teams.
- Coordinate the collection of any biological samples required as part of the clinical trial/study and ensure safe and appropriate storage of specimens, in conjunction with local nursing teams.
- Ensure the safe administration of trial drugs, have in-depth knowledge of the legal requirements of a clinical trial sponsor regarding pharmacovigilance and of the Trust pharmacovigilance policy. Report any adverse events and reactions in accordance with this policy and the trial protocol.
- At all times to ensure clear, accurate records, developing data collection, case report forms and design of database where required for patient and staff records.
- Implement and adhere to the principles of Good Clinical Practice (GCP) and ensure that all trials are conducted according to the Medicines for Human Use (Clinical Trial) Regulations 2004 and Amended Regulations 2006 where appropriate.
- Liaising with the Joint Clinical Trials Office and Trusts R&D Offices relating to submission of the study for regulatory approval and Trust Management approval. Assist in completing submissions to the Research Ethics Committee as required.
- Perform tasks requiring highly developed clinical skills including phlebotomy, cannulation, etc and the administration of trial drugs, and to keep up to date with current practices for cannulation, phlebotomy etc,
- To oversee the routine maintenance and servicing of clinical equipment
MANAGEMENT:
- To act as clinical supervisor to junior research staff and act as a role model for excellence in clinical research.
- To represent Guys and St Thomas NHS Foundation Trust as an expert research nurse in external situations, for example national and international conferences, committees etc.
- To report any adverse incident/near misses in relation to that activity
- To facilitate and maintain effective communication within the clinical team.
- To responsibly manage the control of equipment, resources and stock through the adherence of research policies and clinical trials budgets.
EDUCATION:
- Ensure mandatory clinical trials training is undertaken and updated as required.
- To be responsible for developing and sustaining own knowledge, clinical skills and professional awareness.
PROFESSIONAL:
- You will be accountable for your own professional actions, and be a lead specialist for defined area acting within clearly defined policies/procedures and codes of conduct including the NMC code and Trust policy.
- To act in accordance with local policies and procedures laid down by Guys and St Thomas NHS Foundation Trust and ensure that all mandatory training for nursing staff within the Trust is attended.
- To work within the NMC Scope of Professional Practice and Code of Conduct.
- To undertake Performance Development Review annually to identify organisational and professional objectives and developmental needs.
- To keep up to date with departmental, Trust, NHS, academic and EU developments for the management of clinical research ensuring timely, effective implementation of changes.
- To attend courses as deemed relevant, including mandatory training, and to attend meetings and conferences as appropriate
Person Specification
Education/ Qualifications
Essential
- NMC level one registration with previous NHS experience
- Degree level (Bsc)
- CPD at masters level or equivalent
Previous experience
Essential
- Considerable experience in clinical trials
- Experience in teaching and mentoring
- In depth knowledge of early phase clinical trials and the drug development process
- Experience to deliver specialised programmes of care, and provide highly specialised advice for patients and healthy volunteers who are participating in clinical trials
- Experience to deliver R&D activities as major component of job
Skills , knowledge and ability
Essential
- Excellent communication skills
- Able to provide and receive complex information in a sensitive manner
- Able to manage complex facts or situations, requiring analysis, interpretation and comparison in relation to research trials/studies
- able to plan and organise complex activities and programmes, requiring formulation and adjustment as necessitated
- able to develop specialist procedure protocols and adhere to all Trust policies and standard operating procedures
- able to teach/deliver core training of individual clinical trial/study protocols
- able to deal with distressed patients and/ or relatives relating to the potential / real outcomes of their health and deal with the emotional consequences of patients coming to terms with long term conditions
Person Specification
Education/ Qualifications
Essential
- NMC level one registration with previous NHS experience
- Degree level (Bsc)
- CPD at masters level or equivalent
Previous experience
Essential
- Considerable experience in clinical trials
- Experience in teaching and mentoring
- In depth knowledge of early phase clinical trials and the drug development process
- Experience to deliver specialised programmes of care, and provide highly specialised advice for patients and healthy volunteers who are participating in clinical trials
- Experience to deliver R&D activities as major component of job
Skills , knowledge and ability
Essential
- Excellent communication skills
- Able to provide and receive complex information in a sensitive manner
- Able to manage complex facts or situations, requiring analysis, interpretation and comparison in relation to research trials/studies
- able to plan and organise complex activities and programmes, requiring formulation and adjustment as necessitated
- able to develop specialist procedure protocols and adhere to all Trust policies and standard operating procedures
- able to teach/deliver core training of individual clinical trial/study protocols
- able to deal with distressed patients and/ or relatives relating to the potential / real outcomes of their health and deal with the emotional consequences of patients coming to terms with long term conditions
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).
