Job summary
Lewisham & Greenwich NHS Trust is developing a spoke site for the newly formed South London Commercial Research Delivery Centre (CRDC). Guy's & St Thomas' is the hub site for commercial research within this new partnership. The South London CRDC will act as a regional hub for commercial research delivery to improve recruitment and set-up of clinical trials and facilitate improved access to research for underserved populations by making research more accessible within local communities.
We have an opportunity for an experienced Research Nurse to join the CRDC team. The Senior Clinical Research Nurse will have a key role in supporting the set-up and coordination of LGT as a spoke site in the new CRDC. Based at the Queen Elizabeth Hospital, Woolwich and working across all Trust and CRDC sites as required, this role will be embedded within the Trust's R&D team. The postholder will be responsible for delivering a range of commercial research from the National Institute for Health (NIHR) Research Portfolio, working with study teams, investigators and CRDC colleagues. The post holder will be responsible for the screening, identification and recruitment of patients to clinical research studies in specialities including cancer, haematology, dermatology and HIV.
This is a cross site role and the post holder will be expected to travel across all Trust and South London CRDC sites as a core element of the role.
Main duties of the job
- Assist the Director for Research & Development, Head of Research, R&D Operations Manager and R&D Delivery Managers in the delivery of the Trust research strategy and CRDC objectives.
- Leadership and clinical oversight of LGT CRDC spoke site, research activities and the commercial research portfolio and support with developing performance reports and study updates.
- Promotion of research to build capability and capacity to increase research activity across the trust.
- Deliver NIHR portfolio recruitment targets.
- Ensure robust research governance processes are in place.
- Leadership and clinical oversight of the RRDN clinical research portfolio and support with development of business cases and bids to increase funding for research opportunities.
- To line manage the research delivery team and provide specialist support to the wider body of research-active staff across the Trust.
- To develop interdisciplinary clinical management protocols and work within them.
About us
Our people are our greatest asset. When we feel supported and happy at work, this positivity reaches those very people we are here for, the patients. Engaged employees perform at their best and our Equality, Diversity & Inclusion (EDI) initiatives contribute to cultivate a culture of engagement. We have four staff networks, a corporate EDI Team and a suite of programmes and events which aim to insert the 5 aspirations:
- Improving representation at senior levels of staff with disabilities, from black, Asian, and ethnic minorities background, identify as LGBTQ+ and women, through improved recruitment and leadership development
- Widening access (anchor institution) and employability
- Improving the experience of staff with disability
- Improving the EDI literacy and confidence of trust staff through training and development
- Making equalities mainstream
Job description
Job responsibilities
- Responsible for screening and recruiting participants to a portfolio of NIHR, non-NIHR and industry led research studies. This includes both randomised clinical trials and other high quality research 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 trusts policies and clinical trial protocol.
- Carry out all relevant clinical trial related activities without direct supervision including medication administration, venepuncture, cannulation and blood sample processing, ECGs and vital sign monitoring of clinical trial participants ensuring that they are carried out as per study protocol, within the trusts policies and in accordance with research governance and regulations.
- Conduct trials in accordance with International Conference on Harmonisation of Good Clinical Practice (ICH GCP) and Data Protection Act.
- Ensure that written informed consent is obtained prior to conducting any research related activities.
- 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).
- Act as an ongoing resource and support to patients and their relatives, explaining all aspects of clinical trials and relevant treatments options.
- Provide and receive complex information in the process of explaining study involvement, including discussing alternative treatments, benefits and risks.
- Monitor and assist in the management and reporting of adverse events according to the study protocol and reporting requirements to maintain patient safety.
- Deliver research according to time and target as required by the sponsor, according to the protocol and the CDRC objectives.
- Ensure that research practices comply with trust policies and procedures.
- Maintain accurate records in clinical trial documents and patient notes.
- To act as Principal Investigator for suitable studies when required.
- To be responsible for and manage the portfolio clinical research projects, collaborating with key personnel throughout the network to ensure continued care and support for patients involved in clinical trials.
- To review research protocols and assess feasibility.
- To ensure that all staff involved in research in the Trust adheres to guidelines around informed consent and Good Clinical Practice.
- To consult with principal investigators (PIs), research organisations and industry in the development and execution of research protocol.
- To oversee the administration of clinical research throughout the project life cycle, from study set-up, initiation through to closure and archiving.
- Maintain accurate documentation in clinical trial documents and patient notes.
- Ensure that clinical trials are effectively archived as required.
Job description
Job responsibilities
- Responsible for screening and recruiting participants to a portfolio of NIHR, non-NIHR and industry led research studies. This includes both randomised clinical trials and other high quality research 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 trusts policies and clinical trial protocol.
- Carry out all relevant clinical trial related activities without direct supervision including medication administration, venepuncture, cannulation and blood sample processing, ECGs and vital sign monitoring of clinical trial participants ensuring that they are carried out as per study protocol, within the trusts policies and in accordance with research governance and regulations.
- Conduct trials in accordance with International Conference on Harmonisation of Good Clinical Practice (ICH GCP) and Data Protection Act.
- Ensure that written informed consent is obtained prior to conducting any research related activities.
- 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).
- Act as an ongoing resource and support to patients and their relatives, explaining all aspects of clinical trials and relevant treatments options.
- Provide and receive complex information in the process of explaining study involvement, including discussing alternative treatments, benefits and risks.
- Monitor and assist in the management and reporting of adverse events according to the study protocol and reporting requirements to maintain patient safety.
- Deliver research according to time and target as required by the sponsor, according to the protocol and the CDRC objectives.
- Ensure that research practices comply with trust policies and procedures.
- Maintain accurate records in clinical trial documents and patient notes.
- To act as Principal Investigator for suitable studies when required.
- To be responsible for and manage the portfolio clinical research projects, collaborating with key personnel throughout the network to ensure continued care and support for patients involved in clinical trials.
- To review research protocols and assess feasibility.
- To ensure that all staff involved in research in the Trust adheres to guidelines around informed consent and Good Clinical Practice.
- To consult with principal investigators (PIs), research organisations and industry in the development and execution of research protocol.
- To oversee the administration of clinical research throughout the project life cycle, from study set-up, initiation through to closure and archiving.
- Maintain accurate documentation in clinical trial documents and patient notes.
- Ensure that clinical trials are effectively archived as required.
Person Specification
Qualifications
Essential
- Registered Nurse
- GCP
- Masters level or equivalent experience
- Post-graduate qualification in clinical research or equivalent
Experience
Essential
- Significant post registration clinical experience
- Extensive experience working within the NHS
- Experience of working within the UK regulatory landscape including IRA, NRES, MHRA, HTA
- Significant experience of clinical trials delivery and management (industry or NHS).
- Experience of leading commercial clinical trials
- Experience of working with academic institutions, industry sponsors and research teams
- Experience of explaining complex concepts to service users in a clear and simplified manner
- Experience of delivering training around R&D
- Experience of staff development and line management responsibilities
- Experience in liaising with a variety of stakeholders - service users and carers, researchers, clinical and non-clinical staff at all levels with varying levels of research expertise
- An understanding of the needs of service users who may wish to be involved in research
- Experience of effective MDT working
- Significant experience of working with service users in a patient facing role
- Experience of financial managment and forecasting trials
Desirable
- Project management experience
- Lead an audit or research study
- Presentation and publishing experience
- Caseload management
- Leading a service
Knowledge
Essential
- Knowledge of research practices, methodologies, clinical trials delivery and the overall research agenda in the NHS.
- Understanding of the National Institute for Health Research, its funding programmes and the national research landscape
- Understanding of Research Governance standards and relevant statutory policy and regulations, eg. EU Directive on Clinical Trials, Good Clinical Practice, Human Tissue Act, Mental Capacity Act
- A comprehensive understanding of the legal, ethical and professional issues surrounding consent to trials.
- Understanding of R&D performance measures within an NHS context.
- Demonstrable ability to work effectively within a complex regulatory environment.
- Demonstratable ability to manage staff performance and disciplinary issues effectively
- Excellent organisation, communication, writing and presentation skills
- Ability to work to agreed deadlines, with strong organisational and time management skills.
- Ability to construct and maintain databases and analyse electronic information.
- Highly proficient in all major MS Office applications and bespoke research data management software applications.
- Interpersonal skills
- Highly developed clinical skills including venepuncture, ECG and vital sign monitoring
- Specialist knowledge of research techniques, analysis and use of information; specialist knowledge of specific clinical conditions underpinned by degree and post-graduate level training, experience to master's level equivalent.
Desirable
- Change management
- Statistics and report writing
Person Specification
Qualifications
Essential
- Registered Nurse
- GCP
- Masters level or equivalent experience
- Post-graduate qualification in clinical research or equivalent
Experience
Essential
- Significant post registration clinical experience
- Extensive experience working within the NHS
- Experience of working within the UK regulatory landscape including IRA, NRES, MHRA, HTA
- Significant experience of clinical trials delivery and management (industry or NHS).
- Experience of leading commercial clinical trials
- Experience of working with academic institutions, industry sponsors and research teams
- Experience of explaining complex concepts to service users in a clear and simplified manner
- Experience of delivering training around R&D
- Experience of staff development and line management responsibilities
- Experience in liaising with a variety of stakeholders - service users and carers, researchers, clinical and non-clinical staff at all levels with varying levels of research expertise
- An understanding of the needs of service users who may wish to be involved in research
- Experience of effective MDT working
- Significant experience of working with service users in a patient facing role
- Experience of financial managment and forecasting trials
Desirable
- Project management experience
- Lead an audit or research study
- Presentation and publishing experience
- Caseload management
- Leading a service
Knowledge
Essential
- Knowledge of research practices, methodologies, clinical trials delivery and the overall research agenda in the NHS.
- Understanding of the National Institute for Health Research, its funding programmes and the national research landscape
- Understanding of Research Governance standards and relevant statutory policy and regulations, eg. EU Directive on Clinical Trials, Good Clinical Practice, Human Tissue Act, Mental Capacity Act
- A comprehensive understanding of the legal, ethical and professional issues surrounding consent to trials.
- Understanding of R&D performance measures within an NHS context.
- Demonstrable ability to work effectively within a complex regulatory environment.
- Demonstratable ability to manage staff performance and disciplinary issues effectively
- Excellent organisation, communication, writing and presentation skills
- Ability to work to agreed deadlines, with strong organisational and time management skills.
- Ability to construct and maintain databases and analyse electronic information.
- Highly proficient in all major MS Office applications and bespoke research data management software applications.
- Interpersonal skills
- Highly developed clinical skills including venepuncture, ECG and vital sign monitoring
- Specialist knowledge of research techniques, analysis and use of information; specialist knowledge of specific clinical conditions underpinned by degree and post-graduate level training, experience to master's level equivalent.
Desirable
- Change management
- Statistics and report writing
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).
