Job summary
The Research Facilitator is an integral part of the research team with a primary responsibility to provide effective facilitation and co-ordination of clinical trials and research project set-up, and administrative support as part of the research team. Duties will include facilitating the set-up of clinical trials; liaison with external trial monitors; ensuring secure storage and archival of clinical trials documents and data and providing timely responses to requests for information.
Other duties include facilitating the organisation of documentation for the Health Research Authority (HRA) and other necessary regulatory processes. The post-holder will also be required to assess, arrange and confirm Trust support for research studies in conjunction with the Research Management Team.
The post-holder will work closely with research support services to assess, arrange, and confirm Trust support for research studies in conjunction with the research team.
Main duties of the job
The post holder will lead on setting up, monitoring and maintaining clinical trials for multiple local and multi-centred clinical trials and provide effective facilitation, co-ordination and administrative support as part of the research team.
The post holder will be a specialist at delivering research across a range of specialities demonstrating advanced knowledge and skill in the relation to the organisation of documentation for the Health Research Authority (HRA) and other necessary regulatory processes.
To support the wider team in the delivery of clinical trials across the Trust.
About us
At UHSussex, diversity is our strength, and we want you to feel included to help us always put the Patient First, as shown in our Outstanding for Caring CQC rating. Your uniqueness and experiences will be part of our creative and innovative community where everyone is encouraged to succeed. We have a range of Staff Networks to help break down barriers, and can offer a buddy to help new members settle in. We're proud to be a Disability Confident Employer (Level 2) and a Veteran Aware Trust. We treat our patients and staff with the same compassion and empathy we expect for ourselves. We're here for them when they need us, and we go above and beyond to meet their needs. This can be seen in our Wellbeing Programme for staff which is extensive and designed to support you when you need it - because we know that to look after others we must first look after ourselves. As a university trust and a leader in healthcare research, we value learning, teaching and training so that we can be the best that we can be. From the moment you start with us and throughout your career we will help you to grow and develop. We hope that in choosing UHSussex you are choosing a long and happy career where you will be able to see the difference you make and feel valued for all that you do. We look forward to receiving your application and the start of your journey with UHSussex.
Job description
Job responsibilities
- To work with the Research Governance Manager and wider research team to facilitate study set up
- Liaise with sponsors to ensure that the correct HRA approved documentation is submitted to enable the compliant running of research projects within the Trust.
- To co-ordinate approvals for the use of Trust resources
- Ensuring the HRA set-up process is completed within a timely manner and appropriate to the resources within the Trust.
- Manage document version control processes to ensure study procedures are conducted in line with the correct protocols.
- Provide confirmation to all relevant parties of Trust agreement and readiness for a research project to proceed.
- To provide on-going oversight of study set up progress, reporting issues and concerns to the Heads of Department as relevant.
- Manage the study amendment process.
- To act as a point of contact for sponsors and others involved in research management.
- Maintain established systems for the collection of data and data processing; this is a significant job responsibility.
- Coordinate and process clinical trial activity data for submission to external collaborative centres ensuring accordance with Data Protection Act and Trust Research Policy.
- Maintain an accurate and detailed audit trail of clinical trials activity within the R&I department.
- Provide external monitors with documents or medical records as required.
- Organise effective archiving of trial related documents.
- To complete documentation for submission of new clinical trials and trial amendments through HRA approval, Trust permission and other relevant regulatory requirements e.g. Ionising Radiation (Medical Exposure) Regulations (IRMER) and Administration of Radioactive Substances Advisory Committee (ARSAC).
- Regularly generate reports as required, ensuring accuracy and attention to detail.
- Support other team members in the preparation of reports and presentations.
- To prepare clinical trials patient information/consent forms/and GP letters using mail merge.
- To format and send data to clinical trials units, research networks and others as required, ensuring compliance with the Data Protection Act and Trust Research Policy.
- To ensure the security of all confidential data collected, including case report forms, source documents and electronically stored data; and ensure patient privacy and dignity when discussing or submitting clinical trial data
- To provide general administrative support to the R&D clinical teams, and assist with clerical duties associated with research study activity e.g. the maintenance of study site files, photocopying, etc.
Job description
Job responsibilities
- To work with the Research Governance Manager and wider research team to facilitate study set up
- Liaise with sponsors to ensure that the correct HRA approved documentation is submitted to enable the compliant running of research projects within the Trust.
- To co-ordinate approvals for the use of Trust resources
- Ensuring the HRA set-up process is completed within a timely manner and appropriate to the resources within the Trust.
- Manage document version control processes to ensure study procedures are conducted in line with the correct protocols.
- Provide confirmation to all relevant parties of Trust agreement and readiness for a research project to proceed.
- To provide on-going oversight of study set up progress, reporting issues and concerns to the Heads of Department as relevant.
- Manage the study amendment process.
- To act as a point of contact for sponsors and others involved in research management.
- Maintain established systems for the collection of data and data processing; this is a significant job responsibility.
- Coordinate and process clinical trial activity data for submission to external collaborative centres ensuring accordance with Data Protection Act and Trust Research Policy.
- Maintain an accurate and detailed audit trail of clinical trials activity within the R&I department.
- Provide external monitors with documents or medical records as required.
- Organise effective archiving of trial related documents.
- To complete documentation for submission of new clinical trials and trial amendments through HRA approval, Trust permission and other relevant regulatory requirements e.g. Ionising Radiation (Medical Exposure) Regulations (IRMER) and Administration of Radioactive Substances Advisory Committee (ARSAC).
- Regularly generate reports as required, ensuring accuracy and attention to detail.
- Support other team members in the preparation of reports and presentations.
- To prepare clinical trials patient information/consent forms/and GP letters using mail merge.
- To format and send data to clinical trials units, research networks and others as required, ensuring compliance with the Data Protection Act and Trust Research Policy.
- To ensure the security of all confidential data collected, including case report forms, source documents and electronically stored data; and ensure patient privacy and dignity when discussing or submitting clinical trial data
- To provide general administrative support to the R&D clinical teams, and assist with clerical duties associated with research study activity e.g. the maintenance of study site files, photocopying, etc.
Person Specification
Experience/Qualifications
Essential
- Educated to degree level or equivalent level of work experience
- Excellent IT skills: Microsoft Office, Adobe design software or equivalent.
Desirable
- Good Clinical Practice (GCP) training
- Experience in a research role in the NHS
EDI
Essential
- Evidence of having undertaken own development to improve understanding of equalities issues
- Evidence of having championed diversity in previous roles (as appropriate to role)
Person Specification
Experience/Qualifications
Essential
- Educated to degree level or equivalent level of work experience
- Excellent IT skills: Microsoft Office, Adobe design software or equivalent.
Desirable
- Good Clinical Practice (GCP) training
- Experience in a research role in the NHS
EDI
Essential
- Evidence of having undertaken own development to improve understanding of equalities issues
- Evidence of having championed diversity in previous roles (as appropriate to role)
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.
