Clinical Research Governance Coordinator
This is an exciting opportunity for an experienced and highly motivated individual to join the existing Research Governance Office at King’s and support the set up and management of high-quality clinical research.
The Research Governance Office sits within the wider Research Governance, Ethics and Integrity (RGEI) team and is responsible for providing administrative support to ensure that King’s sponsored research falling under the remit of the Health Research Authority (HRA)/NHS Research Ethics Service is conducted and managed in line with the UK Policy Framework for Health and Social Care Research and all other relevant legal and regulatory frameworks.
The role holder will contribute to the effective and efficient support of a diverse portfolio of research at King’s, through the delivery and promotion of the College’s Clinical Research Governance processes, delivery of training, and support of the development of clear and concise policy and guidance.
The role holder will develop expert knowledge of research governance requirements pertaining to all types of research from basic science studies to clinical trials. They will provide authoritative advice and guidance to the research community relating to issues of sponsorship, regulatory and HRA governance processes, NHS Research Ethics Committee (NHS REC) operating procedures and amendments, and facilitate the continued development of internal processes to support this.
The role holder will provide operational support to the Research Governance Manager by leading and managing a portfolio of research studies for governance and sponsorship reviews at application, pre and post regulatory submission stages.
The role holder will also provide broader research governance support to play a key role in the effective management of the King’s clinical research portfolio. The role holder will engage proactively with a range of stakeholders to understand user needs, resolve issues and identify and capitalise on opportunities for improvement.
The College now adopts a hybrid working model of home and on campus working. The role holder will be based at the Lavington Steet Building, part of the King’s Waterloo Campus when on site. Comprehensive training for all aspects of the role will be provided.
This post will be offered on an indefinite contract.
This is a full-time post - 100% full time equivalent.
- To provide comprehensive, proactive research governance support to researchers requiring Health Research Authority Review (HRA) and/or National Health Service Research Ethics Committee (NHS REC) approval at all stages of the research process, ensuring Kings’ research is conducted in line with relevant policies, legal and regulatory requirements.
- To act as a key point of co-ordination, liaison and advice for investigators seeking approvals for King’s sponsored HRA-relevant projects, and provision of specialist advice relating to HRA and NHS Ethics processes and research and development governance issues.
- To develop and maintain an up-to-date understanding of the requirements of the UK Policy Framework for Health and Social Care Research, governance issues and requirements in relation to the Research Ethics Committees for the NHS, the HRA and the UK General Data Protection Act, and associated research governance national legislation and updates through proactive horizon scanning and assimilation into local guidance.
- Supporting researchers in determining sponsorship arrangements.
- Liaise with research staff in the development and review of new KCL sponsored research projects, conducting sponsorship reviews on behalf of King’s through facilitating the preparation, review and finalisation of essential documentation to enable the set-up of new studies.
- Liaise with research staff in the development and review of amendments to existing KCL sole-sponsored studies, and to the ongoing monitoring and close out of projects.
- Responsible for maintaining the registration and onward monitoring processes in systems such as EDGE, for Kings’ sole sponsored research applications.
- Lead service improvement and projects on behalf of the Research Governance Office.
- Leading on development, implementation and embedding of research governance related policy and procedure, supported by the Research Governance Manager and Head of Research Ethics and Governance. This will include the development of both local standard operating procedures and College wide policy and guidance to support and inform the research community.
- Creating and delivering reports, presentations and Committee briefings in relation to research governance matters, to effectively embed College and national requirements within the King’s research community.
- Prepare and disseminate any necessary communications to the research community in relation to research governance matters, via newsletters, emails and the continued maintenance of the research governance webpages.
- Providing secretariat support and representing the RGO at committee and working group meetings as required.
- To establish and develop good working relationships with each of the following teams - Trust R&D Research Governance, King’s Health Partners Clinical Trials Office (KHP CTO), King’s Clinical Trials Unit (KCTU), King’s Contracts and Pre-award, the broader Research Governance, Ethics and Integrity (RGEI) team and other relevant governance functions within the College such as Research Assurance, Research Insurance and Information Compliance.
- Proactively engaging and delivering training with researchers (staff and students) and faculty research support teams, across all faculties conducting health and social care research.
- To take responsibility for the Research Governance Office central inboxes, monitoring and responding to queries with expert advice.
- To support staff at King’s Health Partners Research and Development (R&D) offices at South London and the Maudsley (SLaM), King’s College Hospital (KCH) and Guy’s and St Thomas’ NHS Foundation Trusts by advising on associated King’s policy for projects co-sponsored between the King’s Health Partner trusts and King’s College London as required and facilitating shared processes, for example funding confirmation checks.
- Provide wider support to the Research Governance, Ethics and Integrity office as required.
The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.
Skills, knowledge, and experience
- Degree, HND, NVQ 4 qualified or equivalent in relevant subject/relevant formal training, plus relevant experience in similar or related roles. Or Significant vocational experience, demonstrating development through involvement in a series of progressively more demanding relevant work/roles, and the acquisition of appropriate professional or specialist knowledge.
- Experience of research governance processes through supporting or leading clinical research in an HEI or NHS research setting.
- Knowledge and understanding of the UK Policy Framework for Health and Social Care Research and/or other regulatory issues pertaining to clinical research governance.
- Experience of developing guidelines and/or processes.
- Experience of leading on or supporting the development and implementation of training.
- Experience of working independently and showing initiative.
- Ability to work with high attention to detail.
- Ability to consider and analyse complex information and communicate clear outcomes.
- Ability to exercise judgement and make informed decisions.
- Ability and technical knowledge to work with online systems for managing and tracking projects.
- Ability to work well under pressure and to be able to prioritise work in the face of constantly shifting priorities and tight deadlines.
- Ability to work flexibly within the broader research governance team.
- Experience of auditing and monitoring research.
- Experience of conducting sponsorship reviews and/or amendment reviews for HRA/NHS REC research.
- Experience of developing or contributing to the development of policy.
- Knowledge and understanding of research methods.