The R&D Officer will act as a facilitator in the review of research studies sponsored by KGH.
The post-holder will ensure KGH studies are supported from grant application, through to sponsorship approval and initiation at sites. The post holder will ensure studies meet regulatory requirements and other obligations as Sponsor.
The post-holder will be required to work autonomously and will be required to manage their day-to-day workload, prioritising as needed.
The portfolio for which this post holder is responsible for will include (but is not restricted to) clinical trials to study a novel intervention or randomised clinical trial to compare interventions in clinical practice, basic science studies involving procedures with human participants, observational studies, studies administering questionnaires/interviews, studies involving qualitative methods, studies limited to working with human tissue samples (or other human biological samples), studies working with data, and studies involving research tissue banks and research databases.
The post holder will support the development of a research portfolio within the Trust. Through the development and implementation of research systems, will ensure sound research governance under the direction of the senior research nurse at Kettering General Hospital NHS Foundation Trust (KGH).
Main duties of the job
The primary responsibilities of the post holder include:
* Responsible for a caseload of portfolio sponsored studies including regulatory and service support submissions.
* To co-ordinate governance review of research projects within the Trust, including finance, data protection, radiation safety, support departments, and ethical approval.
* To ensure the Trust is up to date with national research developments and that systems and processes are fit for purpose.
* To prioritise support for research projects that are in line with the Trust’s strategic objectives.
* To manage the day to day activities of the Research Office in collaboration with the senior research nurse.
* To maintain a research management system which will enable the efficient co-ordination of research studies, provide a range of reports on study progress and recruitment which can be shared with various Trust groups including CBUs and Quality Governance.
Working for our organisation
Please submit your application as soon as possible as we reserve the right to close any adverts before the closing date once we have received sufficient applications.
Kettering General Hospital NHS Foundation Trust is one of the largest employers in the area and we are on an exciting journey. All our divisions are committed to doing things better, with more efficiency as we update, modernise, and advance.
Our Excellence Values
* Compassion
* Accountability
* Respect
* Integrity
* Courage
We want to recruit the best people to deliver our services across the University Hospitals of Northamptonshire and help to unleash everyone's full potential.
Detailed job description and main responsibilities
* In line with NIHR guidance, to develop and co-ordinate systems for Trust access by external researchers, including arranging pre-engagement checks; maintaining close liaison with Human Resources/recruitment services.
* To ensure contracts with other organisations, including commercial organisations, are scrutinised and are satisfactory and acceptable to the Trust and signed off.
* Closely working with investigators, sites and other relevant parties to formulate and oversee study set-up milestones and timelines.
* Supporting the review of new research grant applications.
* Providing expert guidance to investigators on the requirements for KGH sponsorship.
* Supporting investigators with compiling sponsorship documents and regulatory submissions (including Ethics, Human Tissue Authority (HTA), Confidentiality Advisory Group (CAG), Health Research Authority (HRA) assessment and local assess, arrange and confirm assessments).
* Advising and supporting the NHS and academic costing and contracting processes as sponsor.
* Ensuring studies are supported to a prompt approval in line with KGH and national timeframes whilst ensuring the review is to the highest ethical, legal, governance and scientific standards.
* Regularly updating each party with information on the progress of studies in set-up.
* Processing and reviewing amendments on behalf of KGH as sponsor and other changes to studies during their life course.
Person specification
Education, Training & Qualifications
* Educated to degree level or equivalent.
* Postgraduate level qualification or equivalent extensive research experience.
* Knowledge and detailed understanding of national R&D priorities and developments.
* Expert knowledge and practical application of the UK Research Governance Framework and ethics procedures.
* Knowledge of legislation and regulation relevant to healthcare research.
* Knowledge of DOH, NIHR, Research Council and Charity funding streams.
Knowledge & Experience
* Relevant and proven experience in review of research studies for Sponsorship in the UK.
* Experience in applying relevant legislation to the set-up of research for sponsorship.
* Relevant research management experience in NHS, Academic or Industry.
* Data analytical skills (both quantitative and qualitative) including the analysis of multiple sources of information to ensure compliance with targets and performance indicators.
* Dissemination of complex, specialist information to internal and external stakeholders.
* Allocation of tasks and projects to others and supervision of outcomes.
* Analysing practices and implementing policies or systems to improve outcomes.
* Experience in compiling and submitting research grant or other funding applications.
* Formal Presentations.
* Experience of staff supervision.
Skills
* Evidence of complex relationship building with stakeholders.
* Advanced numeracy and problem-solving skills.
* Experience of working with Microsoft, Word, Excel and PowerPoint.
* Initiating and delivery projects to targets.
* Knowledge of EDGE Research Management System.
* Experience of using databases and of data analytical skills including the analysis of multiple sources of information to ensure compliance with targets and regulatory requirements.
* Ability to prioritise conflicting and changing demands.
* Ability to work independently and on own initiative.
* Experience of delivering training to healthcare or research professionals.
* Excellent communication skills, written and verbal.
* Strong desire to share best practice and find improvements in service delivery.
* The ability to establish appropriate documentation and record keeping.
* Ability to work autonomously and manage own workload and prioritise appropriately.
* Willingness to travel for meetings and training off-site.
Applications will be transferred to TRAC system, by completing an application your are giving authorisation for the transfer of your data.
Correspondence regarding your application will be sent to you via a TRAC system account.
We are an equal opportunities employer, which aims to employ a workforce that reflects the diverse communities we serve. We welcome applications from all suitably qualified persons from all backgrounds.
We welcome applications from members of our black and minority ethnic (BME) communities, especially in relation to senior posts within at KGH.
Applicants who have a disability and meet the essential criteria for the job will be interviewed if you indicate you wish to be considered under the Guaranteed Interview Scheme. If you require a reasonable adjustment at any stage of the recruitment process please make the recruitment services team aware as soon as possible.
Appointments will be made on merit.
In submitting an application form, you authorise Kettering General Hospital (KGH) NHS Foundation Trust to confirm any previous NHS service details via the Electronic Staff Record (ESR) Inter Authority Transfer (IAT) process. Including factual reference, occupational health clearance and statutory and mandatory training record.
If you need to have a Disclosure Barring Service (DBS) check, as a requirement of the role, you will be required to repay the cost of obtaining a DBS check (£49.50) and this amount will be reclaimed from your first salary. From 1st February 2019 all new starters to the Trust are required to join the DBS update service as per Trust DBS Re-checking Policy which has an annual cost of £16. New employees who do not join the update service will be required to pay £49.50 for a new DBS check in 3 years time.
Please note that news starters with KGH are subject to a six month probationary period.
Please ensure that the information you provide on your application form is correct, accurate and that nothing has been omitted. Any information that is stated in your application form in relation to qualifications/training courses/work/education experience/references must be able to be evidenced. Failure to do so may result if your offer being withdrawn.
"Safeguarding is everyone's business. KGH considers Safeguarding a priority amongst its citizen's and a key value for all employed to the service."
Employer certification / accreditation badges
The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.
Application numbers
This vacancy may close early if it receives a high number of applications. Please complete and submit your application in good time to avoid disappointment.
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