Research Management and Governance Officer

Barts Health NHS Trust

This job is now closed

Job summary

This is a new role within the JRMO. The post holder will ensure that studies are approved for sponsorship and gain permission through the regulatory bodies.

The successful applicant will be educated to degree level in a relevant subject and have substantial R&D and staff management experience. You will have experience of clinical trials in the life science sector and have a thorough knowledge of the governance and legislative framework for conducting and sponsoring clinical research studies, including Good Clinical Practice. Knowledge of current national systems and structures for the approval, management and monitoring of clinical research in the NHS is essential as are excellent communication skills and the ability to prepare and deliver presentations and reports to a high standard.

The post is based at the Joint Research Management Office, Barts Health, Dept. W, Mile End Road.

Candidates must be able to demonstrate their eligibility to work in the UK in accordance with the Immigration, Asylum and Nationality Act 2006. Where required this may include entry clearance or continued leave to remain under the Points Based Immigration Scheme

Informal enquiries about this post can be made to Safia Ornelas: s.ornelas@qmul.ac.uk or Tumi Kaminskas t.kaminskas@qmul.ac.uk

Main duties of the job

This position sits within the Joint Research Management Office that oversees and supports all research across Barts Health Trust and Queen Mary University of London (QMUL). The post holder will provide advice and guidance to the research community at Barts Health NHS Trust and QMUL. The post holder will be responsible for administering the approvals system including sponsorship of research at Barts Health NHS Trust and QMUL.

The Research Management and Governance (RM&G) Officer post sits within the Research Governance & Performance team and will be responsible for ensuring the provision of high quality data management for studies at Barts Health NHS Trust. This will be underpinned by the effective delivery of a number of research management systems and functions, including local JRMO processes, advise on Honorary contracts, study management processes, and supporting regulatory inspections in the organisation. The post holder will be key to developing and maintaining good working relationships between Barts Health NHS Trust, its constituent departments, QMUL and the Clinical Research Network (CRN) Management Team using excellent communication, interpersonal and information management skills.

About us

Barts Health is one of the largest NHS trusts in the country, and one of Britain's leading healthcare providers.

The Barts Health group of NHS hospitals is entering an exciting new era on our improvement journey to becoming an outstanding organisation with a world-class clinical reputation. Having lifted ourselves out of special measures, we now have the impetus and breathing space to chart a fresh course in which we are continually striving to improve all our services for patients.

Our vision is to be a high-performing group of NHS hospitals, renowned for excellence and innovation, and providing safe and compassionate care to our patients in east London and beyond. That means being a provider of excellent patient safety, known for delivering consistently high standards of harm-free care and always caring for patients in the right place at the right time. It also means being an outstanding place to work, in which our WeCare values and behaviours are visible to all and guide us in how we work together.

We strive to live by our WeCare values and are committed to promoting inclusion, where every staff member has a sense of belonging. We value our differences and fully advocate, cultivate and support an inclusive working environment.

Date posted

23 May 2023

Pay scheme

Agenda for change

Band

Band 5

Salary

£34,089 to £41,498 a year per annum inc

Contract

Permanent

Working pattern

Full-time, Flexible working

Reference number

259-5332917GSS

Job locations

Dept W, 69-89 Mile End Road, E1 4UJ

London

E1 4UJ

Job description

Job responsibilities

We are dedicated to being an outstanding place to work and will work with you to get the best experience. We know flexible working is not a one size fits all and will mean something different to everyone. We are inclusive, so if you are interested in flexible working, please speak to the recruiting manager.

Study approvals

The Research Management and Governance Officer will be responsible forsupporting researchers in study set up, submission of study applications,sponsorship review, and confirmation of capacity & capability reviews including administration of all amendments within the JRMO systems. The activities required may vary from study to study. The JRMO currently administer over 1,000 projects.

Key responsibilities will include:

Research Governance

Undertake research governance reviews of applications for sponsorship approval providing advice and guidance to researchers as per JRMO SOPs.

Support study feasibility and sponsorship activities for research projects that Barts Health and QMUL sponsor. This will include liaison with researchers, service support departments at site and external facilities (e.g. pharmacy, radiology/imaging and laboratory services).

Participate in meetings and co-ordinate activities to gain approval from relevant departments/individuals.

Ensure that relevant departments review relevant study documentation and confirm that each department / individual is satisfied that adequate resources are available to enable the site to participate in the study.

Liaise with the JRMO costing and contracting, pre-award & post-award teams to ensure adequate resource is in place prior to sponsorship decisions.

Conduct local feasibility review for hosted and sponsored studies and issue confirmation of capacity & capability to undertake the research as per relevant JRMO SOPs. Undertake amendment reviews for sponsored and hosted research studies as per JRMO SOPs.

Support investigators to navigate all NIHR approval systems including Heath Research Authority processes, NIHR portfolio adoption process and other regulatory bodies including the MHRA, the national research ethics service (NRES) and the national Confidential Advisory group (CAG) etc.

Provide advice and guidance on research governance issues to research teams.

Facilitate and advice researchers in developing sponsorship applications and necessary regulatory & ethical approvals, this may involve meeting researcher at early stage.

Work closely with the R&D Operations Manager, the Governance Team Leader Senior Research Governance & Management Officer, GCP and Compliance Team and JRMO staff and investigators at site, to identify and resolve any issues that may affect the gaining of sponsorship or NHS permission.

Information Management

The post holder will ensure that study details are entered onto local and national databases as required and that information is accurate, complete and up to date.

The post holder will be responsible for identifying any missing data on their caseload and updating it on the local portfolio management system.

Maintain the internal study files as per JRMO SOPs.

The Research Management and Governance Officer will assist in the generation of reports as required by Barts Health NHS Trust, Queen Mary University of London, the NIHR and DoH and other external stakeholders.

The post holder will facilitate/advice investigator on registration of clinical trials on clinicaltrials.gov or similar platforms

Communication and relationships

The Research Management and Governance Officer will play a key role inensuring effective communications with the researchers within Barts Health NHS Trust, QMUL and NIHR research networks. This will include:

Support Governance Officer & deputise as necessary/instructed.

Work across sites to ensure support is provided to the research teams asnecessary.

Arranging and attending meetings to discuss research studies with investigators and their teams.

Providing feedback to researchers during the approval process keeping them fully updated of progress.

Contribution to the preparation of reports and newsletters for researchers, the JRMO, other stakeholders and other relevant groups.

Take Part and contribute in outreach sessions, drop in sessions or trainingcourses organised by JRMO governance team

Assist in drafting or editing SOPs pertinent to role as required.

Contribute in planning and preparation as requested for any regulatoryinspection/audit

Support new members of the team including training on internal processes.

The Job holder is expected to keep knowledge up to date by learning and training and to support personal development.

Person Specification

The JRMO is a complex, diverse and challenging environment in which the Research management and governance officer has a key role. The post holder must have well developed database skills and the ability to deliver and receive highly complex information. Post holders will have developed knowledge of research governance and regulatory issues underpinned by theory and experience.

The post holder needs to provide the following specific experience andcompetencies:

Knowledge, Training and Experience

Knowledge across a range of RM&G procedures, or alternatively knowledge in certain RM&G procedures, acquired through a degree or equivalent experience.

Skills, Abilities, and Attributes

Ability to communicate technical information both orally and in writing, both internally to colleagues and externally to a range of audiences.

Proven interpersonal skills to work with clinical and management colleagues at all levels across a range of organisations.

Ability to prepare reports to a high standard.

Excellent information management skills, including the ability to produce, analyse and interpret research management information.

Strong problem solving skills.

Ability to plan, manage and deliver study set up and approval, involving multiple individuals and a range of tasks, to tight deadlines.

Ability to work with minimal day-to-day supervision.

Very good IT skills, particularly in the use of Web applications and MS Office applications.

Flexible approach to working and a desire to develop knowledge.

Excellent Attention to detail.