Job summary
The focus for this role is to provide support to the delivery and/or set up of National Institute for Health and Care Research Research Delivery Network (NIHR RDN) Portfolio studies across varied health and care settings. This will require flexible autonomous working across disciplines and the Regional RDN (RRDN) region. This post has a dual function and the post holder will either contribute to research delivery and/or research support for wider care settings dependent upon regional need. Research delivery will involve the correct identification, recruitment, delivery and follow up for research participants according to the appropriate research protocols. Research support will involve engaging with stakeholders to promote research activity, site identification, set up and associated governance. The post holder will need interpersonal and leadership skills to facilitate collaborative working relationships across a breadth of stakeholders to maximise engagement opportunities. The role will work alongside different professions from multiple organisations involved in health and care research and will be an integral part of the Agile Research Delivery Team which sits within the RRDN core team. The post holder will also work closely with the Study Support Service and the Stakeholder and Engagement team. The post holder will be accountable to the Agile Research Delivery Team Clinical Manager.
Main duties of the job
The RDN will support:
- Clinical trials and other well-designed health and social care research studies (including studies that are delivered outside of an NHS setting);
- Public health studies that require the recruitment of individuals within an NHS setting (that is, acute, ambulance, mental health, community or primary care) or an episode of care which involves contact with the NHS.
About us
Guy's and St Thomas' NHS Foundation Trust comprises five of the UK's best-known hospitals - Guy's, St Thomas', Evelina London Children's Hospital, Royal Brompton and Harefield - as well as community services in Lambeth and Southwark, all with a long history of high-quality care,clinical excellence, research and innovation.
We are among the UK's busiest, most successful foundation trusts. We provide specialist care for patients including heart and lung, cancer and renal services as well as a full range of local hospital and community services for people in Lambeth and Southwark.
Organisational Values:
The post holder will be:
Caring - we put patients first
Ambitious - we innovate and strive for excellence
Inclusive - we respect each other and work collaboratively
Our values and behaviours framework describes what it means for every one of us in the Trust to put our values into action.
Job description
Job responsibilities
FOR RESEARCH DELIVERY:
- Accurately perform and record a range of participant assessments and physiological measurements required, according to personal competencies and the study protocol. This may include, but not be limited to; venepuncture, blood pressure, urinalysis, weight and height.
- Appropriately document and report any serious adverse events and incidents according to regulatory requirements.
- Ensure that relevant approvals are in place prior to commencing a study.
- Using appropriate manual and computerised systems, ensure accurate collection and maintenance of all research records and results, ensuring that all data can be verified.
- Provide timely information and reports to reflect recruitment of patients including timely entry to Local Project Management Systems (LPMS).
- Raise awareness of problems relating to IT and software systems, and work with the Senior Agile Research Delivery Nurse/ AHP/ CRP and IT departments to resolve them e.g. problems with online data submission forms.
FOR RESEARCH SUPPORT FOR WIDER CARE SETTINGS:
- Understand complex information and data to support decisions and plans relating to the Agile Research Delivery Team.
- In collaboration with the Study Support Service, facilitate implementation of Information Governance best practice within systems supporting the operation of the Agile Research Delivery Team and wider care settings.
- Ensure data integrity within relevant RDN systems, identifying potential concerns and patterns, and advising RDN customers and partners in resolving issues.
- Undertake the processes required to continually ensure high quality and integrity of data within the portfolio management systems.
- Support the use of digital innovations including data visualisation tools/dashboards and digital recruitment services to inform study and process decision making.
- Actively contribute to activities and service processes that support wider care settings study sponsors, funders and investigators to access data to enable them to effectively manage the delivery of their studies (and enable them to request support from the RDN as required).
- Utilise operational activity data for cost attribution and allocation of studies, ensuring accurate data support for regional wider care organisations.
- In collaboration with the Study Support Service, ensure compliance with the DHSC RDN Portfolio Policy that the process, procedure and monitoring of studies enables sponsors / delegates, research delivery sites and funders to understand and adhere to their roles and responsibilities. For example, this may include satisfying the Eligibility Criteria for NIHR support before they are included on the portfolio and subsequently adhering to the expected actions and requirements set out in the NIHR RDN Portfolio Terms and Conditions.
- Contribute to the oversight of the RDN wider care settings portfolio to proactively identify potential issues and opportunities, working as an active partner to resolve and action follow-up activity.
- Support relevant Study Sponsors and delegates in the utilisation of the Sponsor Engagement Tool to secure visibility of real-time research activity data and help identify capacity in the health and care research system to deliver research quickly and efficiently.
- Actively contribute to the coordination of the National Specialty and Setting Groups (e.g. arranging meetings, taking notes).
- Provide administrative support (e.g. note-taking and action tracking) to facilitate operational and project delivery and to capture learnings and knowledge for national network benefit.
Job description
Job responsibilities
FOR RESEARCH DELIVERY:
- Accurately perform and record a range of participant assessments and physiological measurements required, according to personal competencies and the study protocol. This may include, but not be limited to; venepuncture, blood pressure, urinalysis, weight and height.
- Appropriately document and report any serious adverse events and incidents according to regulatory requirements.
- Ensure that relevant approvals are in place prior to commencing a study.
- Using appropriate manual and computerised systems, ensure accurate collection and maintenance of all research records and results, ensuring that all data can be verified.
- Provide timely information and reports to reflect recruitment of patients including timely entry to Local Project Management Systems (LPMS).
- Raise awareness of problems relating to IT and software systems, and work with the Senior Agile Research Delivery Nurse/ AHP/ CRP and IT departments to resolve them e.g. problems with online data submission forms.
FOR RESEARCH SUPPORT FOR WIDER CARE SETTINGS:
- Understand complex information and data to support decisions and plans relating to the Agile Research Delivery Team.
- In collaboration with the Study Support Service, facilitate implementation of Information Governance best practice within systems supporting the operation of the Agile Research Delivery Team and wider care settings.
- Ensure data integrity within relevant RDN systems, identifying potential concerns and patterns, and advising RDN customers and partners in resolving issues.
- Undertake the processes required to continually ensure high quality and integrity of data within the portfolio management systems.
- Support the use of digital innovations including data visualisation tools/dashboards and digital recruitment services to inform study and process decision making.
- Actively contribute to activities and service processes that support wider care settings study sponsors, funders and investigators to access data to enable them to effectively manage the delivery of their studies (and enable them to request support from the RDN as required).
- Utilise operational activity data for cost attribution and allocation of studies, ensuring accurate data support for regional wider care organisations.
- In collaboration with the Study Support Service, ensure compliance with the DHSC RDN Portfolio Policy that the process, procedure and monitoring of studies enables sponsors / delegates, research delivery sites and funders to understand and adhere to their roles and responsibilities. For example, this may include satisfying the Eligibility Criteria for NIHR support before they are included on the portfolio and subsequently adhering to the expected actions and requirements set out in the NIHR RDN Portfolio Terms and Conditions.
- Contribute to the oversight of the RDN wider care settings portfolio to proactively identify potential issues and opportunities, working as an active partner to resolve and action follow-up activity.
- Support relevant Study Sponsors and delegates in the utilisation of the Sponsor Engagement Tool to secure visibility of real-time research activity data and help identify capacity in the health and care research system to deliver research quickly and efficiently.
- Actively contribute to the coordination of the National Specialty and Setting Groups (e.g. arranging meetings, taking notes).
- Provide administrative support (e.g. note-taking and action tracking) to facilitate operational and project delivery and to capture learnings and knowledge for national network benefit.
Person Specification
Education and Qualification
Essential
- Educated to degree level
- CRPs should be on, or working towards accredited registration with the AHCS
Knowledge and Experience
Essential
- Knowledge of the governance and legislative framework for conducting clinical research studies, including ICH Good Clinical Practice.
- Knowledge of the clinical trial and health and care research lifecycle including experience of the set up and delivery of research studies in a health and care setting.
- Experience of the care of patients/participants enrolled in research studies or a customer focussed role.
Skills and Abilities
Essential
- Good IT skills, particularly in the use of Web applications, MS Office and/or Google Hub applications.
- Ability to plan and coordinate multidisciplinary activities associated with the management and delivery of research study(ies)
Person Specification
Education and Qualification
Essential
- Educated to degree level
- CRPs should be on, or working towards accredited registration with the AHCS
Knowledge and Experience
Essential
- Knowledge of the governance and legislative framework for conducting clinical research studies, including ICH Good Clinical Practice.
- Knowledge of the clinical trial and health and care research lifecycle including experience of the set up and delivery of research studies in a health and care setting.
- Experience of the care of patients/participants enrolled in research studies or a customer focussed role.
Skills and Abilities
Essential
- Good IT skills, particularly in the use of Web applications, MS Office and/or Google Hub applications.
- Ability to plan and coordinate multidisciplinary activities associated with the management and delivery of research study(ies)
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).
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).
