Job summary
The purpose of this role is to support the R&D Operations Manager in the process of approving, maintaining, amending and closing research projects taking place at University Hospitals Plymouth NHS Trust. In this role it is envisaged that the post holder will learn about the research projects ongoing in a large acute hospital and how to apply the legislation and guidance associated with the safe performance of clinical research in this setting.
For more information, please contact Elinor Pegg elinor.pegg1@nhs.net 01752 431977
***Preference will be given to internal Trust staff, as well as 'Priority' and 'At Risk' status including NHS At Risk staff throughout Devon who are able to display recent relevant experience as dictated by the Person Specification.***
Main duties of the job
The R&D Office facilitates and governs the management of all research projects ongoing in this Trust, from first introduction and feasibility review, through internal approval and active recruitment of patient, and any amendments to project details and finally trial closure and archiving. At any one time there can be approximately 200 feasibilities, almost 100 projects in development and more than 500 active projects. The role of the research support facilitators is to provide administrative support for these projects, as a part of the integrated Research and Development office
About us
We are a people business - where every member of staff matters and can make a difference. Patients are at the heart of everything we do. Joining University Hospitals Plymouth NHS Trust means becoming part of a team of dedicated staff, who are committed to leading the way through innovation, clinical excellence and great customer care. The Trust has great opportunities for career development in a highly progressive working environment. We offer all of this in a vibrant, modern city with a historic reputation for adventure. PLEASE NOTE THAT ALL COMMUNICATION WILL BE ELECTRONIC, PLEASE CHECK YOUR EMAIL ACCOUNT REGULARLY. If you have any issues with applying online and need additional support including reasonable adjustments with the application process please contact the recruitment team on 01752 432100. We recognise that work life balance is important for our colleagues and so we invite requests from applicants around less than full time/flexible working for our advertised roles. Please contact the recruiting manager to discuss this prior to your application submission. We commit to giving this full consideration in each case. We encourage people from diverse backgrounds to apply for our roles, as diversity strengthens our teams. It is sometimes necessary to close vacancies before the closing date. If you have not heard from us within 4 weeks of the closing date, please assume that you have not been shortlisted.
Job description
Job responsibilities
Advice and Support
To act as a first point of contact for researchers, receiving queries by telephone, e-mail and in personwith an ability to guide them clearly to the appropriate person for guidance through the complicatedR&D application processes. Researchers may be very experienced or may be attempting their firstforays into research - the ability to target and adapt communication style is therefore crucial. To become proficient in the use of our web-based electronic research database such as EDGE to enter,update and retrieve project information, to be able to use the web-based systems eg: NIHR operatingdata platform ODP . Liaise with and support investigators, research nurses, trial co-ordinators, Clinical Research NetworkStaff, and external Clinical Research Associates to ensure full trial documentation sets are availableand in place before authorisation of R&D Confirmation of Capacity and Capability. The completion ofapplications must be organised in a timely and efficient manner. Provide effective and timely communication with ethics committees, R&D offices, investigators and themulti-disciplinary teams, pharmaceutical companies and other research organisations such as theUniversities.
R&D Approvals Facilitation
Liaise with the R&D Finance team to ensure that Clinical Trials Agreements are in place and the studiesare fully costed before approval is given. Making the R&D Finance team aware of any potential studydelays. To learn to identify the different types of R&D projects (Clinical Trial of an Investigational MedicinalProduct [CTIMPs] and non-CTIMPs, device studies, genetics, Phase I, commercial and academic), inorder to make appropriate and accurate judgements concerning their approval and governancerequirements. To be aware of and deliver studies to national and local targets and timelines, whilst also being sensitiveto the wider research environment and understanding the possible impact on a delivery teams othercommitments to research. To learn to complete the necessary governance checks and administration tasks of studies such ascontract type and Statement of Events (SoE). To ensure that all local and study wide checks are up todate, reflecting information in the R&D study files, in a timely and accurate manner and to be aware ofthe implications of inaccuracy. Appropriately identify when external researchers may require Research Passports, Honorary Contractsor Letters of Access for studies and to notify the line manager accordingly, in order to issue thedocuments in a timely fashion. Work closely with integrated teams within the R&D Office and teams across the South West Peninsulain collation of full document sets. To set up and maintain R&D study files in accordance with the latest Trust Standard OperatingProcedures (SOPs), International Conference on the Harmonisation of Good Clinical Practice (ICHGCP) and other regulatory body requirements. To draft and issue appropriately signed Trust Approval Letters/emails, containing accurate informationand to disseminate copies to all relevant parties in a timely and professional manner.
For further details please see the attached JD & PS
Job description
Job responsibilities
Advice and Support
To act as a first point of contact for researchers, receiving queries by telephone, e-mail and in personwith an ability to guide them clearly to the appropriate person for guidance through the complicatedR&D application processes. Researchers may be very experienced or may be attempting their firstforays into research - the ability to target and adapt communication style is therefore crucial. To become proficient in the use of our web-based electronic research database such as EDGE to enter,update and retrieve project information, to be able to use the web-based systems eg: NIHR operatingdata platform ODP . Liaise with and support investigators, research nurses, trial co-ordinators, Clinical Research NetworkStaff, and external Clinical Research Associates to ensure full trial documentation sets are availableand in place before authorisation of R&D Confirmation of Capacity and Capability. The completion ofapplications must be organised in a timely and efficient manner. Provide effective and timely communication with ethics committees, R&D offices, investigators and themulti-disciplinary teams, pharmaceutical companies and other research organisations such as theUniversities.
R&D Approvals Facilitation
Liaise with the R&D Finance team to ensure that Clinical Trials Agreements are in place and the studiesare fully costed before approval is given. Making the R&D Finance team aware of any potential studydelays. To learn to identify the different types of R&D projects (Clinical Trial of an Investigational MedicinalProduct [CTIMPs] and non-CTIMPs, device studies, genetics, Phase I, commercial and academic), inorder to make appropriate and accurate judgements concerning their approval and governancerequirements. To be aware of and deliver studies to national and local targets and timelines, whilst also being sensitiveto the wider research environment and understanding the possible impact on a delivery teams othercommitments to research. To learn to complete the necessary governance checks and administration tasks of studies such ascontract type and Statement of Events (SoE). To ensure that all local and study wide checks are up todate, reflecting information in the R&D study files, in a timely and accurate manner and to be aware ofthe implications of inaccuracy. Appropriately identify when external researchers may require Research Passports, Honorary Contractsor Letters of Access for studies and to notify the line manager accordingly, in order to issue thedocuments in a timely fashion. Work closely with integrated teams within the R&D Office and teams across the South West Peninsulain collation of full document sets. To set up and maintain R&D study files in accordance with the latest Trust Standard OperatingProcedures (SOPs), International Conference on the Harmonisation of Good Clinical Practice (ICHGCP) and other regulatory body requirements. To draft and issue appropriately signed Trust Approval Letters/emails, containing accurate informationand to disseminate copies to all relevant parties in a timely and professional manner.
For further details please see the attached JD & PS
Person Specification
Qualifications
Essential
- NVQ level 3 in related subject, or equivalent demonstrable experience
Knowledge & Experience
Essential
- Excellent IT skills, using Microsoft Office and web-based databases.
- Good telephone skills
- Pervious demonstrable experience of working in an large clinical setting
Desirable
- Proven knowledge of medical terminology
- An understanding of medical research processes
- Demonstrable experience of working in an NHS environment.
Aptitude & Abilities
Essential
- Good communication skills, written and verbal, with ability to demonstrate fluency, clarity and effectiveness at all levels.
- Ability to learn quickly and retain knowledge.
Person Specification
Qualifications
Essential
- NVQ level 3 in related subject, or equivalent demonstrable experience
Knowledge & Experience
Essential
- Excellent IT skills, using Microsoft Office and web-based databases.
- Good telephone skills
- Pervious demonstrable experience of working in an large clinical setting
Desirable
- Proven knowledge of medical terminology
- An understanding of medical research processes
- Demonstrable experience of working in an NHS environment.
Aptitude & Abilities
Essential
- Good communication skills, written and verbal, with ability to demonstrate fluency, clarity and effectiveness at all levels.
- Ability to learn quickly and retain knowledge.
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).
