Research Governance Officer
| Posting date: | 16 September 2024 |
|---|---|
| Salary: | £44,806.00 to £53,134.00 per year |
| Additional salary information: | £44806.00 - £53134.00 a year |
| Hours: | Full time |
| Closing date: | 30 September 2024 |
| Location: | London, EC1V 2PD |
| Company: | NHS Jobs |
| Job type: | Contract |
| Job reference: | C9273-24-0415 |
Summary
To support data collection for R&D Governance oversight via generation of reports and compliance with internal and external requirements. To work collaboratively with the research teams to ensure consistent governance requirements of the joint R&D and Delivery teams are met. The post-holder will be expected to be up to date with all new regulations and support these are disseminated appropriately to the wider organisation. Support the tracking of study progress to ensure compliance with and adherence to the project plan and HRA requirements, and to identify, evaluate and rectify barriers. Ensuring efficient and effective data management, undertaking routine data quality validation checks throughout the study lifecycle. To continually support the tracking of studies to ensure that they are conducted in accordance with ICH GCP and (where applicable) UK clinical trials legislation. Ensure all data are handled and processed in accordance with the Data Protection Act, Caldicott Guidelines and Trust Information Governance policies and procedures. Act as a point of contact between research teams and governance team. Support study teams in using and uploading documents to eTMF and to undertake quality checks of documents. Take lead in the collection of data, and the preparation and presentation of reports and information, ensuring that these meet the oversight requirements. Understand the requirements of the various controlling bodies, agencies and frameworks, guiding the project in conforming to those requirements and co-ordinating any necessary audit, monitoring processes. To manage workload priorities ensuring the more urgent and important tasks are completed first within required timescales. To be proactive in the identification of workload or process issues that affect clinical service provision and, with the support of the Research Governance Manager, develop and implement action plans along with the Research Governance Specialist to track oversight of studies. Liaise with investigators, fund holders and departmental teams to maintain accurate reports and data of research studies close-out activities. Support research governance oversight by tracking the frequency and conduct of committees and study team meetings through the maintenance of oversight trackers. Support quality checks of trial data recorded and study documents stored in different platforms and internal systems. Monitoring compliance with reporting requirements to regulatory, REC and other internal and external parties. Check and make sure that documentation of processes and evidence are saved in the right location and appropriately. Support oversight of the implementation of adequate processes by research teams and delegated parties in the conduct, delivery and closure of studies. To support the monitoring of sponsored and hosted studies applying research governance principles and GCP in accordance with all relevant regulations. To support oversight of the maintenance and review of risk assessment plans by working with research teams. To produce ad hoc reports about the portfolio status of studies linked to governance oversight and monitoring. Supporting team meetings and work of the various groups and bodies associated with the trial through the development of reports based on study activities. Quality checking of documentation uploaded to the eTMF, and all applicable electronic systems. Ensure that personal and confidential information is restricted to those entitled to know. To extract relevant data from NHS Edge, Trial Interactive (eTMF), electronic records and study documents to develop periodic reports relating to studies governance and oversight. Undertake clerical/secretarial tasks as required by the research governance team. Undertake any other duties commensurate with the grade. Participate as an active member of the Governance Team. Develop and maintain computer systems to record research activity, reviewing IT requirements regularly and preparing user manuals and system documentation. Prepare tabulated and graphical summary information on research activity as required. Upload trial data onto electronic data capture system. Resolve data queries in collaboration with the designated research teams. Maintain accurate and up to date data at all times. Play a key role in ensuring that all research activities in MEH complies with the Data Protection Act and that confidentiality is maintained. Promote/advise best practice to researchers (liaising with the Trust Data Protection Officer). To liaise with the Trusts Freedom of Information Officer regarding requests received for information from the public and stake holders.