Job summary
An opportunity has arisen for a highly motivated and enthusiastic individual to join the Research & Development Department (R&D) as a Research Sponsorship Facilitator to support the development and delivery of our home-grown research studies portfolio at RCHT. The successful candidate will provide a complete and comprehensive administration and coordination service across the Trust, to determine best practice and inform policy, planning and service development which will contribute to the home-grown research knowledge base and support the development of ideas that would improve the quality of care for patients.
To enable comprehensive support to researchers across the Trust, candidates should have excellent knowledge of the UK Policy Framework for Health and Social Care, the principles of Good Clinical Practice and the statutory instruments relating to the investigation of medicines, plus extensive knowledge of research processes within the NHS.
We are seeking a flexible, proactive, team player who is a self-starter with excellent written and verbal communication skills. The successful candidate will be expected to work autonomously, be IT literate; organised; be able to work to a high standard of detail and accuracy; ideally have experience with NHS clinical care systems; have previous data management and clinical research experience.
Main duties of the job
To create and maintain a database of RCHT sponsored research in order to manage the RCHT sponsored studies portfolio.
Support potential researchers in the development of research projects by sign posting to appropriate organisations and individuals for help and support.
Signposting researchers in sourcing relevant funding opportunities from multiple agencies.
Provide guidance and support researchers on the documentation that should be completed and submitted to the appropriate authority before and during the delivery of the study. This includes the IRAS application form, research database registration, annual reports and the end of study report.
Complete or prepare the documentation on behalf of the sponsor for appropriate authorisation. This includes the Schedule of Event Cost Attribution Tool (SoECAT)
Support and advise researchers on processing amendments; this includes preparing the documentation, liaising with the Study Set-up team and assisting the Senior Management Team with the classification of amendments.
Liaising with Patients and Public Involvement Engagement (PPIE) groups to ensure the community is consulted and involved in RCHT sponsored research. This may include undertaking surveys of public and patient involvement in research at RCHT.
About us
The Royal Cornwall Hospitals NHS Trust (RCHT) is the main provider of acute and specialist care services in Cornwall and the Isles of Scilly. We serve a population of around 500,000 people - a figure that can increase significantly with
visitors during the busiest times of the year. We employ approximately 6,700 staff and have a budget of approximately £580 million.
We are a teaching hospital in partnership with the University of Exeter Medical School, University of Plymouth School of Nursing and Midwifery, and Peninsula Dental School.
The Knowledge Spa on the Royal Cornwall Hospital site is the base for medical and nursing as well as ongoing education for health professions in clinical and non-clinical roles.
Keeping at the forefront of medical advances, we are continually developing our clinical services as well as our facilities and are committed to maximising the range of specialist care that can be offered locally. Allied to this is a growing reputation for research and innovation.
Royal Cornwall Hospitals NHS Trust is a research active organisation.
It's established South West Clinical School in Cornwall exists to promote clinical academic career opportunities for nurses, midwives and allied health professionals interested in research and evidence-based activities. Read their research paper to find out more.
Website: https://www.plymouth.ac.uk/research/clinical-schools/royal-cornwall-hospitals-nhs-trust-clinical-school
https://doi.org/10.1177/17449871231209037
Job description
Job responsibilities
To represent the sponsor at meetings with internal and external organisations and other trusts hosting RCHT sponsored research and advising the group of the sponsor requirements.
Support the Research Governance Manager in running the Sponsor Oversight Committee (SOC); keeping the members up to date with the status of existing research projects and new projects in the pipeline.
Maintain the sponsor e-mail account, responding to enquiries, filing documents, compiling safety alerts for governance review and escalating or alerting senior staff to emails requiring action as applicable.
Ensure the Trial Master Files are maintained. This includes liaising with the Study Set-up team and R&D Governance Officer to ensure good version control and all RCHT sponsored research is filed appropriately.
Oversee the sponsor research process. Compiling a manual of work instructions detailing the processes undertaken by the sponsor in the development and delivery of a research project
Prepare and provide appropriate training sessions on research processes for individuals or groups as required.
To be responsible for planning, organising and prioritising own workload to meet the demands from all stake holders.
To maintain regular contact with researchers for the duration of the research project to ensure a successful and timely completion of each study and all milestones are reached, recorded and appropriately reported.
To provide and receive highly complex data and information and recognise and understand the sensitivity of different types of research data and communicate these when necessary.
Responsibility for updating and maintaining various research databases and spreadsheets in line with national research governance requirements.
To understand the principles of research governance, and good clinical practice to ensure research work generated complies with these legal and regulatory requirements.
Job description
Job responsibilities
To represent the sponsor at meetings with internal and external organisations and other trusts hosting RCHT sponsored research and advising the group of the sponsor requirements.
Support the Research Governance Manager in running the Sponsor Oversight Committee (SOC); keeping the members up to date with the status of existing research projects and new projects in the pipeline.
Maintain the sponsor e-mail account, responding to enquiries, filing documents, compiling safety alerts for governance review and escalating or alerting senior staff to emails requiring action as applicable.
Ensure the Trial Master Files are maintained. This includes liaising with the Study Set-up team and R&D Governance Officer to ensure good version control and all RCHT sponsored research is filed appropriately.
Oversee the sponsor research process. Compiling a manual of work instructions detailing the processes undertaken by the sponsor in the development and delivery of a research project
Prepare and provide appropriate training sessions on research processes for individuals or groups as required.
To be responsible for planning, organising and prioritising own workload to meet the demands from all stake holders.
To maintain regular contact with researchers for the duration of the research project to ensure a successful and timely completion of each study and all milestones are reached, recorded and appropriately reported.
To provide and receive highly complex data and information and recognise and understand the sensitivity of different types of research data and communicate these when necessary.
Responsibility for updating and maintaining various research databases and spreadsheets in line with national research governance requirements.
To understand the principles of research governance, and good clinical practice to ensure research work generated complies with these legal and regulatory requirements.
Person Specification
Qualifications
Essential
- Degree or equivalent level qualification
- ICH-GCP or willing to undertake suitable training
- ECDL or equivalent IT qualification.
Desirable
- Professional qualification which included research methods
- Questionnaire and Survey development
Experience
Essential
- Previous experience of working in clinical research
- Experience of reviewing research protocols
- Experience of research processes in the NHS
- Understanding of the research sponsorship process and the research pathway and providing advice and support to researchers on the process
- Experience of research governance and legal and regulatory requirements
- Previous experience of receiving, interpreting and analysing complex data
- Preparing, writing and presenting reports
Desirable
- Experience of using databases (eg EDGE)
- Experience of grant writing
- Experience of working within the NHS
- Experience of chairing meetings
Skills
Essential
- Able to communicate effectively with staff of different disciplines.
- Ability to perform tasks to a high level of detail and accuracy
- Project planning experience and ability to work to strict timelines
- Knowledge of developing clinical health research
- Excellent concentration skills to assure high standards of detail & accuracy in completion of Case Report Forms.
- Ability to work independently and on own initiative with guidance available from colleagues
Desirable
- Ability to train others in using IT software
- Knowledge of NHS information systems, eg PAS
- Familiarity of reporting of research findings in healthcare journals
Person Specification
Qualifications
Essential
- Degree or equivalent level qualification
- ICH-GCP or willing to undertake suitable training
- ECDL or equivalent IT qualification.
Desirable
- Professional qualification which included research methods
- Questionnaire and Survey development
Experience
Essential
- Previous experience of working in clinical research
- Experience of reviewing research protocols
- Experience of research processes in the NHS
- Understanding of the research sponsorship process and the research pathway and providing advice and support to researchers on the process
- Experience of research governance and legal and regulatory requirements
- Previous experience of receiving, interpreting and analysing complex data
- Preparing, writing and presenting reports
Desirable
- Experience of using databases (eg EDGE)
- Experience of grant writing
- Experience of working within the NHS
- Experience of chairing meetings
Skills
Essential
- Able to communicate effectively with staff of different disciplines.
- Ability to perform tasks to a high level of detail and accuracy
- Project planning experience and ability to work to strict timelines
- Knowledge of developing clinical health research
- Excellent concentration skills to assure high standards of detail & accuracy in completion of Case Report Forms.
- Ability to work independently and on own initiative with guidance available from colleagues
Desirable
- Ability to train others in using IT software
- Knowledge of NHS information systems, eg PAS
- Familiarity of reporting of research findings in healthcare journals
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).
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