Research Support Officer
- Employer
- University Hospitals of Leicester NHS Trust
- Location
- Leicester
- Salary
- £28,407 to £34,581 a year per annum
- Closing date
- 8 Jun 2023
View more
- Profession
- Healthcare scientist
- Grade
- Band 5
- Contract Type
- Permanent
- Hours
- Full Time
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The Research Support Officer will work as part of a team of staff led by the Research Manager in the Hope Clinical Trials Centre.
The Hope Clinical Trials Centre is located at the Leicester Royal Infirmary and is a dedicated area for cancer patients participating in clinical research studies, particularly those at the early stages of development.
The department hosts approximately 40 staff members who hold either administrative or clinical positions but work closely together to provide the best possible care for our patients.
The Research Support Officer will be responsible for supporting researchers and clinical teams in the local set-up of clinical trials and will coordinate the process of Capacity and Capability assessment in order to receive Research & Innovation Authorisation to conduct the research at our centre.
Main duties of the job
The Research Support Officer will work as part of a team of staff led by the Research Manager in the Hope Clinical Trials Centre.
The Research Support Officer will be responsible for ensuring that studies are reviewed, set up and submitted for R& I Authorisation in a timely manner.
Keeping abreast of legislation, the post-holder will also be responsible for implementing national best practice research management processes within the Trust in a streamlined manner.
The post-holder will be the day to day point of contact for investigators and external Sponsors and will be responsible for providing advice and support where necessary.
The post holder should be adaptable, flexible and show initiative. In addition they need to show good communication skills, be able to liaise with all levels of staff, demonstrate good organisational skills and attention to detail, have good time management skills and be flexible as the working hours may not be fixed.
Opportunities to develop expertise in other research specialties will be available. The post-holder may be required to work in other research areas across UHL if service needs arise.
About us
We are one of the biggest and busiest NHS trusts in the country, incorporating the General, Glenfield and Royal Infirmary hospitals. We have our very own Children's Hospital and run one of the country's leading heart centres. Our team is made up of more than 17,000 staff providing a range of services primarily for the one million residents of Leicester, Leicestershire and Rutland. We work with partners at the University of Leicester and De Montfort University providing world-class teaching to nurture and develop the next generation of doctors, nurses and other healthcare professionals, many of whom go on to spend their working lives with us. Our purpose is to provide 'Caring at its best' and our staff have helped us create a set of values that embody who we are and what we're here to do. They are:
We focus on what matters most.
We treat others how we would like to be treated.
We are passionate and creative in our work.
We do what we say we are going to do.
We are one team and we are best when we work together
Our patients are at the heart of all we do and we believe that 'Caring at its best' is not just about the treatments and services we provide, but about giving our patients the best possible experience.
About the University Hospitals of Leicester NHS Trust (leicestershospitals.nhs.uk
Job description
Job responsibilities
Background
This is a unique and exciting opportunity for an individual experienced in research to join the Research & Innovation (R& I) research delivery workforce at University Hospitals of Leicester NHS Trust.
University Hospitals of Leicester hosts the NIHR Leicester Biomedical Research Centre and the NIHR Clinical Research Facilities including the Hope Clinical Trials Facility, a centre of excellence in oncology and haematology research and the Clinical Renal Research Unit, a leading centre in national recruitment of patients in clinical trials.
All research facilities are designed to deliver clinical effectiveness, safety and a positive patient/volunteer experience in a consistent way.
JOB SUMMARY
The Research Support Officer will work as part of a team of staff led by the Research Manager in the Hope Clinical Trials Centre.
The Research Support Officer will be responsible for supporting researchers and clinical teams in the local set-up of clinical trials and will coordinate the process of Capacity and Capability assessment in order to receive R& I Authorisation.
Keeping abreast of legislation, the post-holder will also be responsible for implementing national best practice research management processes within the Trust. They will be responsible for ensuring that local integration of systems and processes are achieved so that individuals can benefit fully from this in a streamlined manner.
The Research Support Officer will be responsible for identifying and addressing Trust specific feasibility issues and ensuring that studies are reviewed, set up and submitted for R& I Authorisation in a timely manner.
The post-holder will be the day to day point of contact for investigators and external Sponsors and will be responsible for providing advice and support where necessary.
The post holder should be adaptable, flexible and show initiative. In addition they need to show good communication skills, be able to liaise with all levels of staff, demonstrate good organisational skills and attention to detail, have good time management skills and be flexible as the working hours may not be fixed.
Opportunities to develop expertise in other research specialties will be available. The post-holder may be required to work in other research areas across UHL if service needs arise.
INFORMATION MANAGEMENT
Ensure databases are completed accurately and maintained appropriately.
To work autonomously
Is organised and able to manage and prioritise own workload in order to meet specific deadlines.
Budget: Not applicable for role.Staff: Not applicable for role.Policy: Trust wide policies to be implemented.Communications: Good communication skills will be paramount to this position with the involvement of working across clinical business units to include physicians, MDT, research scientists, patients and carers.
KEY WORKING RELATIONSHIPS
Director of the HOPE Clinical Trials Centre Other senior Managers within the HOPE Clinical Trials Centre Finance and Contracts Manager Quality Assurance Manager All staff within the Clinical Trials Facility Investigators/Clinicians Other research associates/departments within the University of Leicester NHS Trust Other partners e.g NIHR Research Networks, ECMC Research active personnel & support services at UHL, University of Leicester, DeMontfort University UHL Research & Innovation Office Health Research Authority Research Ethics Committees External Organisations e.g. commercial companies Other Universities Other NHS Trusts
WORKING RELATIONSHIPSTo develop and maintain a good working relationship with multi-professional teams within the speciality.
Be responsibility for ensuring effective communication between all service providers within the speciality.Actively participate in local and national networking groups to develop an expert level of knowledge in the speciality.
KEY RESULT AREAS
Research Management & Governance Work closely with colleagues in the Research Team to support implementation of research management processes within the Trust. Maintain a standard of conduct in accordance with trust policies Be accountable for actions and aware of limitations. Conduct financial reviews of clinical trials to ensure that they are adequately resourced. Contribute to the implementation of quality systems providing assurance to researchers that processes operate in accordance with the law, national and best practice. Support the Research Manager in providing assurances and evidence that research management processes are compliant with Governance Frameworks, relevant legislation including but not limited to the EU Directive, HRA, , REC, MHRA, ARSAC , Human Tissue Act, GTAC, CAG,MCA and the Department of Health. Provide specialist expert regulatory and governance advice and support by actively promoting the research management and governance process to deliver a smooth operation to researchers in all aspects of preparing study documentation for NHS authorisation, including but not limited to IRAS, the application process, ethics application process, finance and contracts, NHS indemnity, and highlighting where necessary requirements for Research Passports and Honorary Research Contracts. Assist researchers with applications that do not require NHS Ethics opinion or are exempt from HRA review, to ensure a smooth and streamlined approach to obtaining NHS Trust authorisation. Ensure that all projects have the necessary checks in place: e.g. HRA Approval, REC FIFO letter, MHRA, CAG, G-TAC, CMG approval, financial approval, relevant support services approvals etc. and that the required documentation is provided for review. Ensure all research applications/amendments are reviewed as appropriate in accordance with tight national deadlines, maintaining the Trusts reputation for expediency. Determine impact on Capacity and Capability and adopt a proactive approach in identifying and rectifying issues at an early stage, communicating with points of contact for individual research studies then facilitating best outcome. Signpost and highlight as appropriate when contracts are required to the Research Contracts Manager in order to ensure that all relevant contracts are in place prior to approval of a new research study or amendment at the Trust. Support the Research Manager to ensure that all research studies are and continue to be properly resourced and conducted according to applicable regulations Support the Research Manager, Quality Assurance Manager within the wider Hope Team in implementing Standard Operating Procedures, local guidance and other procedures based on national operating guidelines and current legislation by effectively communicating the purpose of the procedures and any changes to all staff involved with the Capacity and Capability Assessment processes for studies based in the Trust.
Information ManagementEnsure that spreadsheets and databases are completed accurately and maintained appropriately.Work autonomously to manage and prioritise own workload in order to meet specific internal and external deadlines.
Monitoring / Audit & Performance ManagementAssist in undertaking the administrative processes involved in preparing for, hosting and responding to inspections or audits by internal and external regulatory bodies, agencies and other organisations.
Ensure that researchers are familiar with and understand their responsibilities in respect of the delivery of recruitment targets with timelines.
Communication & Relationship SkillsDevelop and maintain constructive relationships with staff across the Trust as part of the review process, communicate directly with researchers, dealing with telephone or email queries and provide one to one advice or meetings, referring to agreed guidelines and using own initiative to action responses when appropriate.
Communicate directly with staff and agencies such as HRA assessors, research ethics committees, Universities, commercial companies, and Research Networks, as part of the capacity and capability review process and to raise overall awarenessAdapt appropriate methods of communication and persuasion skills to overcome strong resistance to bureaucratic processes.
Training & EducationTo assist the Research Manager & Quality Assurance Manager in identifying the learning needs of oneself and colleagues by seeking appropriate training that is relevant to the role.
R& I Directorate1. Identify personal educational needs associated with participation in current clinical trials and ensure these are effectively communicated to the Research Nurse. Participates in the development of an agreed personal development plan to meet identified needs.
2. Ensure safe standards of practice through identification of areas of risk associated with participation in clinical trials. Ensure clinical trial protocols and appropriate professional guidelines are adhered to.
3. Participate in the implementation of research practice standards.
4. Responsible for remaining adequately informed of clinical trials, R& I activity and the Trust by attendance at team brief and using other appropriate forms of communication.
GENERAL
This job description indicates the main functions and responsibilities of the post. It is not intended to be a complete list. You may be required to undertake other duties from time to time as we may reasonably require.
You will be required to maintain compliance with all statutory and mandatory training requirements.
The link to the Trusts policies and procedures is:
https://secure.library.leicestershospitals.nhs.uk/PAGL/SitePages/Home.aspx
Person Specification
Commitment to Trust Values and Behaviours
Essential
Training & Qualifications
Essential
358-5293120-CHU
The Hope Clinical Trials Centre is located at the Leicester Royal Infirmary and is a dedicated area for cancer patients participating in clinical research studies, particularly those at the early stages of development.
The department hosts approximately 40 staff members who hold either administrative or clinical positions but work closely together to provide the best possible care for our patients.
The Research Support Officer will be responsible for supporting researchers and clinical teams in the local set-up of clinical trials and will coordinate the process of Capacity and Capability assessment in order to receive Research & Innovation Authorisation to conduct the research at our centre.
Main duties of the job
The Research Support Officer will work as part of a team of staff led by the Research Manager in the Hope Clinical Trials Centre.
The Research Support Officer will be responsible for ensuring that studies are reviewed, set up and submitted for R& I Authorisation in a timely manner.
Keeping abreast of legislation, the post-holder will also be responsible for implementing national best practice research management processes within the Trust in a streamlined manner.
The post-holder will be the day to day point of contact for investigators and external Sponsors and will be responsible for providing advice and support where necessary.
The post holder should be adaptable, flexible and show initiative. In addition they need to show good communication skills, be able to liaise with all levels of staff, demonstrate good organisational skills and attention to detail, have good time management skills and be flexible as the working hours may not be fixed.
Opportunities to develop expertise in other research specialties will be available. The post-holder may be required to work in other research areas across UHL if service needs arise.
About us
We are one of the biggest and busiest NHS trusts in the country, incorporating the General, Glenfield and Royal Infirmary hospitals. We have our very own Children's Hospital and run one of the country's leading heart centres. Our team is made up of more than 17,000 staff providing a range of services primarily for the one million residents of Leicester, Leicestershire and Rutland. We work with partners at the University of Leicester and De Montfort University providing world-class teaching to nurture and develop the next generation of doctors, nurses and other healthcare professionals, many of whom go on to spend their working lives with us. Our purpose is to provide 'Caring at its best' and our staff have helped us create a set of values that embody who we are and what we're here to do. They are:
We focus on what matters most.
We treat others how we would like to be treated.
We are passionate and creative in our work.
We do what we say we are going to do.
We are one team and we are best when we work together
Our patients are at the heart of all we do and we believe that 'Caring at its best' is not just about the treatments and services we provide, but about giving our patients the best possible experience.
About the University Hospitals of Leicester NHS Trust (leicestershospitals.nhs.uk
Job description
Job responsibilities
Background
This is a unique and exciting opportunity for an individual experienced in research to join the Research & Innovation (R& I) research delivery workforce at University Hospitals of Leicester NHS Trust.
University Hospitals of Leicester hosts the NIHR Leicester Biomedical Research Centre and the NIHR Clinical Research Facilities including the Hope Clinical Trials Facility, a centre of excellence in oncology and haematology research and the Clinical Renal Research Unit, a leading centre in national recruitment of patients in clinical trials.
All research facilities are designed to deliver clinical effectiveness, safety and a positive patient/volunteer experience in a consistent way.
JOB SUMMARY
The Research Support Officer will work as part of a team of staff led by the Research Manager in the Hope Clinical Trials Centre.
The Research Support Officer will be responsible for supporting researchers and clinical teams in the local set-up of clinical trials and will coordinate the process of Capacity and Capability assessment in order to receive R& I Authorisation.
Keeping abreast of legislation, the post-holder will also be responsible for implementing national best practice research management processes within the Trust. They will be responsible for ensuring that local integration of systems and processes are achieved so that individuals can benefit fully from this in a streamlined manner.
The Research Support Officer will be responsible for identifying and addressing Trust specific feasibility issues and ensuring that studies are reviewed, set up and submitted for R& I Authorisation in a timely manner.
The post-holder will be the day to day point of contact for investigators and external Sponsors and will be responsible for providing advice and support where necessary.
The post holder should be adaptable, flexible and show initiative. In addition they need to show good communication skills, be able to liaise with all levels of staff, demonstrate good organisational skills and attention to detail, have good time management skills and be flexible as the working hours may not be fixed.
Opportunities to develop expertise in other research specialties will be available. The post-holder may be required to work in other research areas across UHL if service needs arise.
INFORMATION MANAGEMENT
Ensure databases are completed accurately and maintained appropriately.
To work autonomously
Is organised and able to manage and prioritise own workload in order to meet specific deadlines.
Budget: Not applicable for role.Staff: Not applicable for role.Policy: Trust wide policies to be implemented.Communications: Good communication skills will be paramount to this position with the involvement of working across clinical business units to include physicians, MDT, research scientists, patients and carers.
KEY WORKING RELATIONSHIPS
Director of the HOPE Clinical Trials Centre Other senior Managers within the HOPE Clinical Trials Centre Finance and Contracts Manager Quality Assurance Manager All staff within the Clinical Trials Facility Investigators/Clinicians Other research associates/departments within the University of Leicester NHS Trust Other partners e.g NIHR Research Networks, ECMC Research active personnel & support services at UHL, University of Leicester, DeMontfort University UHL Research & Innovation Office Health Research Authority Research Ethics Committees External Organisations e.g. commercial companies Other Universities Other NHS Trusts
WORKING RELATIONSHIPSTo develop and maintain a good working relationship with multi-professional teams within the speciality.
Be responsibility for ensuring effective communication between all service providers within the speciality.Actively participate in local and national networking groups to develop an expert level of knowledge in the speciality.
KEY RESULT AREAS
Research Management & Governance Work closely with colleagues in the Research Team to support implementation of research management processes within the Trust. Maintain a standard of conduct in accordance with trust policies Be accountable for actions and aware of limitations. Conduct financial reviews of clinical trials to ensure that they are adequately resourced. Contribute to the implementation of quality systems providing assurance to researchers that processes operate in accordance with the law, national and best practice. Support the Research Manager in providing assurances and evidence that research management processes are compliant with Governance Frameworks, relevant legislation including but not limited to the EU Directive, HRA, , REC, MHRA, ARSAC , Human Tissue Act, GTAC, CAG,MCA and the Department of Health. Provide specialist expert regulatory and governance advice and support by actively promoting the research management and governance process to deliver a smooth operation to researchers in all aspects of preparing study documentation for NHS authorisation, including but not limited to IRAS, the application process, ethics application process, finance and contracts, NHS indemnity, and highlighting where necessary requirements for Research Passports and Honorary Research Contracts. Assist researchers with applications that do not require NHS Ethics opinion or are exempt from HRA review, to ensure a smooth and streamlined approach to obtaining NHS Trust authorisation. Ensure that all projects have the necessary checks in place: e.g. HRA Approval, REC FIFO letter, MHRA, CAG, G-TAC, CMG approval, financial approval, relevant support services approvals etc. and that the required documentation is provided for review. Ensure all research applications/amendments are reviewed as appropriate in accordance with tight national deadlines, maintaining the Trusts reputation for expediency. Determine impact on Capacity and Capability and adopt a proactive approach in identifying and rectifying issues at an early stage, communicating with points of contact for individual research studies then facilitating best outcome. Signpost and highlight as appropriate when contracts are required to the Research Contracts Manager in order to ensure that all relevant contracts are in place prior to approval of a new research study or amendment at the Trust. Support the Research Manager to ensure that all research studies are and continue to be properly resourced and conducted according to applicable regulations Support the Research Manager, Quality Assurance Manager within the wider Hope Team in implementing Standard Operating Procedures, local guidance and other procedures based on national operating guidelines and current legislation by effectively communicating the purpose of the procedures and any changes to all staff involved with the Capacity and Capability Assessment processes for studies based in the Trust.
Information ManagementEnsure that spreadsheets and databases are completed accurately and maintained appropriately.Work autonomously to manage and prioritise own workload in order to meet specific internal and external deadlines.
Monitoring / Audit & Performance ManagementAssist in undertaking the administrative processes involved in preparing for, hosting and responding to inspections or audits by internal and external regulatory bodies, agencies and other organisations.
Ensure that researchers are familiar with and understand their responsibilities in respect of the delivery of recruitment targets with timelines.
Communication & Relationship SkillsDevelop and maintain constructive relationships with staff across the Trust as part of the review process, communicate directly with researchers, dealing with telephone or email queries and provide one to one advice or meetings, referring to agreed guidelines and using own initiative to action responses when appropriate.
Communicate directly with staff and agencies such as HRA assessors, research ethics committees, Universities, commercial companies, and Research Networks, as part of the capacity and capability review process and to raise overall awarenessAdapt appropriate methods of communication and persuasion skills to overcome strong resistance to bureaucratic processes.
Training & EducationTo assist the Research Manager & Quality Assurance Manager in identifying the learning needs of oneself and colleagues by seeking appropriate training that is relevant to the role.
R& I Directorate1. Identify personal educational needs associated with participation in current clinical trials and ensure these are effectively communicated to the Research Nurse. Participates in the development of an agreed personal development plan to meet identified needs.
2. Ensure safe standards of practice through identification of areas of risk associated with participation in clinical trials. Ensure clinical trial protocols and appropriate professional guidelines are adhered to.
3. Participate in the implementation of research practice standards.
4. Responsible for remaining adequately informed of clinical trials, R& I activity and the Trust by attendance at team brief and using other appropriate forms of communication.
GENERAL
This job description indicates the main functions and responsibilities of the post. It is not intended to be a complete list. You may be required to undertake other duties from time to time as we may reasonably require.
You will be required to maintain compliance with all statutory and mandatory training requirements.
The link to the Trusts policies and procedures is:
https://secure.library.leicestershospitals.nhs.uk/PAGL/SitePages/Home.aspx
Person Specification
Commitment to Trust Values and Behaviours
Essential
- Must be able to demonstrate behaviours consistent with the Trust's Values and Behaviours
Training & Qualifications
Essential
- Educated to degree level or equivalent in related area (e.g. Science, Social Services, healthcare) or relevant experience ECDL or equivalent IT Skills
358-5293120-CHU
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