Job Description

Lewisham & Greenwich NHS Trust is developing a spoke site for the newly formed South London Commercial Research Delivery Centre (CRDC). Guy's & St Thomas' is the hub site for commercial research within this new partnership. The South London CRDC will act as a regional hub for commercial research delivery, delivering research across DGHs, community organisations and primary care to improve recruitment and set-up of clinical trials and facilitate improved access to research for underserved populations by making research more accessible within local communities.



Lewisham & Greenwich NHS Trust has an opportunity for an experienced Research Governance Facilitator to join the CRDC team. The post holder will have a key operational role in supporting Lewisham & Greenwich NHS Trust as a spoke site. Embedded within the Trust's Research and Development team, the post holder will be responsible for delivering a range of commercial and non-commercial research studies from the National Institute for Health Research (NIHR) Portfolio, working with the local clinical study teams, investigators and CRDC colleagues.



The post-holder will



Facilitate the study feasibility, set up and approval of commercial and non-commercial studies

Contribute to the financial management of the studies open at the Trust

Provide advice to researchers and investigators concerning the governance and management of studies to be set-up



The post will be based at Queen Elizabeth Hospital, Woolwich however this is a cross-site role and the post holder will be expected to work across all Trust and GSTT CRDC sites as a core element of the role.



Our people are our greatest asset. When we feel supported and happy at work, this positivity reaches those very people we are here for, the patients. Engaged employees perform at their best and our Equality, Diversity & Inclusion (EDI) initiatives contribute to cultivate a culture of engagement. We have four staff networks, a corporate EDI Team and a suite of programmes and events which aim to insert the 5 aspirations:



Improving representation at senior levels of staff with disabilities, from black, Asian, and ethnic minorities background, identify as LGBTQ+ and women, through improved recruitment and leadership development



Widening access (anchor institution) and employability



Improving the experience of staff with disability



Improving the EDI literacy and confidence of trust staff through training and development



Making equalities mainstream



Service Management



Liaison with the Trust support departments to ensure that the capacity and expertise exists to recruit successfully to a given study.



Facilitate the approval process of new studies and amendments in line with the latest governance requirements.



Support the Operations team in the set-up of clinical trials, including assisting investigators to determine recruitment targets during study set-up and feasibility assessment.



Ensures the cost implications of research activities have been appropriately considered in liaison with Operations team and Head of Research.



Ensure the study recruitment figures are reported weekly onto the R&D database in accordance with local and national requirements.



Provide accurate and reliable reports from the R&D database for both internal and external reporting requirements.



Prepare and provide Letters of Access and Honorary Contracts in accordance with the HR Good Practice guidelines.



Undertake risk assessment, audit and monitoring in compliance with national requirements.



Facilitate the archiving of study documentation in accordance with guidelines and sponsor requirements.



Support commercial sponsors with monitoring of their studies on the LGT sites.



Support the Trust in meeting national R&D standards including the UK Policy Framework for Health & Social Care Research, Good Clinical Practice (GCP), Information Governance, Data Protection Act etc;



Prioritise patient safety and the well-being of clinical trial participants at all times.



Work closely with commercial sponsors during feasibility reviews and study setup processes to ensure efficient and timely opening of studies.



Work closely with the South London CRDC Hub management and workforce to coordinate study setup across the hub and spokes.



Service Development



To work to Standard Operating Procedures as required within the UK Policy Framework for Health & Social Care research.



To participate in appropriate meetings internally and externally.



To develop key contacts within the Trust and externally to provide expertise to support research activity.



To proactively seek out barriers to the effective delivery of the research strategy and to be innovative in their solution.



Work collaboratively with the CRDC and other spokes to build efficiencies into feasibility reviews, study setup and opening that can be applied across the CRDC sites.



In collaboration with the GSTT hub and the GSTT Research QA function develop policies and processes for the auditing of relevant CRDC trials.



Develop annual audit plans and support the dissemination of learnings of audit outcomes.



Workforce



Provide advice and guidance to Trust staff on all elements of Research and Development



Maintain own self development and proactively contributes to annual appraisal/performance development review with 6 month review in accordance with Trust policy.



To take responsibility for ensuring own practice and development meets the needs of the role, including keeping up to date with current trends and best practices in the field of Research and Development.



Work as a member of the wider Medical Directorate team, working with colleagues within the department and in the Trust to achieve departmental and Trust wide objectives.