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 manage their day-to-day workload, prioritising as needed.
The portfolio for which this post holder is responsible 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, they 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, providing reports on study progress and recruitment that can be shared with various Trust groups including CBUs and Quality Governance.
About us
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. We have also entered a Group Model with neighbouring Northampton General Hospital NHS Trust and become University Hospitals of Northamptonshire.
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.
The Hospital Group encourages applications from people who identify from all protected groups. We understand that we need to work with colleagues from diverse backgrounds and make sure the environment they work in is inclusive and collaborative.
We recognise the valuable contribution that the Armed Forces community make to our organisation. We have signed the Armed Forces Covenant and achieved Silver Award under the Armed Forces Employer Recognition Scheme.
We have active Networks that promote and support colleagues from all backgrounds. This ensures everyone feels supported and has a sense of belonging working for Kettering and Northampton General Hospitals.
Job description
Job responsibilities
* In line with NIHR guidance, develop and co-ordinate systems for Trust access by external researchers, including arranging pre-engagement checks maintaining close liaison with Human Resources/recruitment services.
* Ensure contracts with other organisations, including commercial organisations, are scrutinised and satisfactory and acceptable to the Trust and signed off.
* Work closely with investigators, sites, and other relevant parties to formulate and oversee study set-up milestones and timelines.
* Support the review of new research grant applications.
* Provide expert guidance to investigators on the requirements for KGH sponsorship.
* Support 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 assessment).
* Advise and support the NHS and academic costing and contracting processes as sponsor.
* Ensure 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 update each party with information on the progress of studies in set-up.
* Process and review amendments on behalf of KGH as sponsor and other changes to studies during their life course.
Person Specification
Education, Training & Qualifications
Essential
* 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
Essential
* Relevant and proven experience in the 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
Essential
* Evidence of complex relationship building with stakeholders.
* Advanced numeracy and problem-solving skills.
* Experience of working with Microsoft Word, Excel, and PowerPoint.
* Initiating and delivering 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.
Key Competencies/ Personal Qualities & Attributes
Essential
* 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.
Employer details
Employer name
Kettering General Hospital NHS Foundation Trust
Address
Kettering General Hospital
Rothwell Road
Kettering
NN16 8UZ
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