Moorfields Eye Hospital NHS Foundation Trust

Research Governance Officer

This job is now closed

Job summary

The post holder will deliver high quality administrative and study team support related to the oversight and governance of clinical trials and other research studies within Moorfields Eye Hospital NHS Foundation Trust.

The post holder will support the research governance team and be expected to fully participate in the continuous improvement work within research and be accountable for supporting periodic trainings on governance, implementation of electronic systems and processes. Key aspects of the role are striving to add value and ensure the highest standards of quality to ensure we have a first-class research support service that optimises research revenue for patient benefit.

To be responsible for supporting and developing the Trust wide systems of R&D registration, approval, oversight tracking and research governance and to be able to use Excel spreadsheets, Power Point and to prepare tabulated and graphical summaries.

Main duties of the job

Responsibilities include overall day to day supporting of research governance activities which include monitoring of studies, preparation for inspections and maintenance of research databases and records.

The post holder will join the research governance team within the Research and Development Department based at Moorfields Eye Hospital. They will work closely with the Research Governance Specialist and other clinical and administrative members of the research team.

The post holder will have past experience of clinical research with a sound working knowledge of current UK clinical trials regulations and Good Clinical Practice requirements. They must possess strong problem solving and analytical skills and be able to work to tight deadlines. He/she will be required to work flexibly and to organise their workload and cope with conflicting demands on their time but prioritise their work accordingly. The nature of the role requires excellent communication and organisation skills and a high level of computer literacy.

He/she is expected to be proactive in developing and implementing procedures and will be required to work with a high degree of autonomy. Much of the work is confidential in nature and the post holder is expected to adhere to MEH information governance and confidentiality policies.

About us

At Moorfields, we provide more than just an excellent career and great colleagues to work with. We also offer:

Salary including High-Cost Area Supplement
Opportunity to join the NHS Pension Scheme
Free 24/7 independent counselling service
Learning and development opportunities
Easy and quick transport links
A range of attractive benefits and discounts
Access to Blue Light Card and other NHS Discount Schemes
Free Pilates classes
Full support and training to develop your skills
Flexible working friendly organisation

And so much more! To see the full range of benefits we offer please see our Moorfields benefits document.

Date posted

16 September 2024

Pay scheme

Agenda for change

Band

Band 6

Salary

£44,806 to £53,134 a year Per Annum, Including HCAS

Contract

Fixed term

Duration

12 months

Working pattern

Full-time

Reference number

273-DC-4527

Job locations

City Road

London

EC1V 2PD

Job description

Job responsibilities

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.