This post is integral to the Research and Innovation Team and is responsible for providing research governance support across our research portfolio. It would ideally suit a candidate with strong research governance experience, In this role, you will be responsible for a programme of monitoring and audit of research projects, and for the collation of key research data required to meet statutory obligations, handling research study set up and amendments, annual reporting and end of study reporting providing support to the Trust’s research programme.
As someone experienced in Research Governance within the NHS and / or Universities, the postholder will be qualified to degree level, or have equivalent experience with knowledge of the governance and legislative framework for conducting clinical research studies, including Good Clinical Practice (GCP) , and The UK Policy Framework for Health and Social Care Research.
With excellent IT skills, particularly in the use of Web applications and MS Office applications including handling / analysing data, they will be proficient in the use of spreadsheets and databases with good attention to detail. This role will require the ability to work with minimal day-to- day supervision with a flexible approach to working, a desire to develop knowledge and work collaboratively as part of the R & I team.
The post has responsibility for managing and developing our Edge interactive database, monitoring and meeting the Trust’s statutory obligations with regard to research governance and monitoring CRN and NIHR targets. The postholder is also responsible for raising invoice requisitions and monitoring payments.
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Our success is underpinned by the skills and enthusiasm of our staff and a strong culture of partnership. We are fully committed to training and development of the workforce with support for continuing education and learning.
Auditing and monitoring:
To be responsible for the monitoring of R&I activity in accordance with the UK Policy Framework for Health and Social Care Research
To alert the Associate Director of Research, Innovation and Improvement to breaches in governance
To ensure data on ODP, CPMS and Edge systems are accurate and up to date
To be responsible for a programme of Audits of research activity within the Trust to ensure adherence to the UK Policy Framework for Health and Social Care Research and Good Clinical Practice guidelines
To facilitate and monitor the implementation of governance recommendations following audit
Research project governance:
To assist with the preparation of formal applications for Ethical Approval and Health Research Authority Approval, and to advise researchers thereon
To build and maintain links with research ethics committees in order to facilitate the ethics approval process
To register Ethics, MHRA and other regulatory approvals, and to liaise with ethics committees on statutory reporting
R&I Management and Reporting
To provide one to one regular support to clinical researchers, advising them to how to process regulatory applications
To act as an expert resource on the national IRAS system - advising researchers on how to navigate it - and the Edge system; and to use both to manage and monitor research studies
To track and monitor R&I income and raise invoice requisitions
To deputise for the Head of Research at meetings when required
To assist with the coordination/implementation of R&I programmes/activities within the Trust
To be responsible for the implementation and maintenance of the Trust’s research database (Edge) and undertake the completion of statutory returns for the NHS Executive, the CRN, and Trust Board as required
To assist with promoting the work of the R&I Department
To aid the Head of Research with the distribution of research information to staff via newsletters and the Intranet
Administrative:
To be responsible for overseeing the development of effective administrative systems within the R&I Department, in line with the requirements of the relevant legislation
To take, transcribe and distribute formal minutes for regular R&I Governance Group Meetings, or oversee this activity
To be responsible for overseeing archiving research studies to GCP standards
To oversee general filing of R&I documents
General:
To prioritise own work ensuring adherence to deadlines while delivering within Departmental and Trust guidelines
To maintain and develop personal skills through participation in continuing professional development, in line with the development of the post and as agreed with the Line Manager as part of the personal development planning process
To participate in the Trust’s performance review and personal development planning process
To maintain confidentiality and security of clinical information in accordance with hospital policy
To follow best practice in health and safety, security and equality and diversity within the Research and Innovation Department
Personal and Professional Development
Participate in the Trust’s annual appraisal system designed to identify objectives and personal development opportunities
Participate in the Trust’s annual pay progression review (if applicable)
Ensure that all mandatory training is up to date
The post holder will be responsible for continually maintaining their working knowledge of local practices, policies and procedures and highlight ongoing training and development needs to their manager.
General:
To undertake any other reasonable duties, responsibilities or projects as requested commensurate with the postholder’s skills, knowledge and experience
