Job summary The post-holder will be responsible for the operational delivery of the Stroke research service's recruitment and follow-up of patients into National Institute Health Research (NIHR) portfolio adopted studies. Working alongside the Clinical Stroke research lead, this will entail portfolio development, operational delivery including managing a core research team, overseeing good governance and assisting with financial oversight, amongst other duties. The post will be responsible for planning, developing and delivering the stroke research portfolio in two secondary care settings. Portfolio development entails setting up and coordinating a broad portfolio of commercial and non-commercial trials and studies - this may include preparing submissions for ethics and regulatory approval, supporting feasibility reviews and trial set-up from inception to completion. As the operational lead, the post will direct the service's recruitment of hyperacute patients within the first few hours of admission in A&E, and acute and sub-acute stroke patients on the wards and in outpatient clinics. In addition to recruitment, the post will be responsible for ensuring the team collects trial data, completes follow-ups and responds to queries as required in a timely and accurate fashion. Main duties of the job Portfolio development Lead the development of the stroke research portfolio, including set-up of and coordination a broad portfolio of NIHR adopted commercial and non-commercial interventional trials and observational studies Assist in process of gaining local regulatory approval before trial commencement. This will entail reviewing feasibility of new trials including resource and funding implications and, for King's Sponsored studies, submitting to regulatory authorities (HRA, REC, MHRA) where required Liaise with local supporting departments (CT Pharmacy, Neuroradiology) regarding set-up and ongoing delivery to promote a good working environment, integration of research within and open channels of communication Operational delivery Lead an established multidisciplinary research team of Research Nurses, Coordinators and Administrators across two sites Provide effective supervision and line management to the clinical research team To assist with recruitment, development, training and all others aspects of people managing including performance management, sickness etc. Delegation of trial related activities to research team members (clinical and administrative) Be accountable for the service and management activities, to ensure smooth running and efficient day-to-day operation of research activities About us King's College Hospital NHS Foundation Trust is one of the UK's largest and busiest teaching Trusts with a turnover of c£1 billion, 1.5 million patient contacts a year and more than 15,000 staff based across South East London. The Trust provides a full range of local and specialist services across its five sites. The trust-wide strategy of Strong Roots, Global Reach is our Vision to be BOLD, Brilliant people, Outstanding care, Leaders in Research, Innovation and Education, Diversity, Equality and Inclusion at the heart of everything we do. By being person-centred, digitally-enabled, and focused on sustainability, we aim to take Team King's to another level. We are at a pivotal point in our history and we require individuals who are ready to join a highly professional team and make a real, lasting difference to our patients and our people. King's is committed to delivering Sustainable Healthcare for All via our Green Plan. In line with national Greener NHS ambitions, we have set net zero carbon targets of 2040 for our NHS Carbon Footprint and 2045 for our NHS Carbon Footprint Plus. Everyone's contribution is required in order to meet the goals set out in our Green Plan and we encourage all staff to work responsibly, minimising their contributions to the Trust's carbon emissions, waste and pollution wherever possible. Date posted 24 January 2025 Pay scheme Agenda for change Band Band 7 Salary £54,320 to £60,981 a year per annum inc HCA's Contract Secondment Working pattern Full-time Reference number 213-CORP-6948540 Job locations King's College Hospital NHS Foundation Trust Denmark Hill London SE5 9RS Job description Job responsibilities Analysis and Research Work closely with other members of core the research team including Research Nurses, Research Coordinators and Research Administrator in data collection, providing training and on-going support Monitor data quality; and perform routine data cleaning, to achieve an accurate and complete dataset. Monitor online data entry, checking for inconsistencies, violations and adverse events Monitor the progress of research activities including preparation of periodic performance review and ad hoc reports as required by investigators, the wider research team, funding agencies and regulatory bodies Provide senior management with project status reports, advise on best project management practice and identify areas that need improvement Planning and Organising Work closely with Kings R&I and KHP CTO to optimise the study set up process Facilitate study set-up at participating sites; and continue to oversee the clinical operations throughout the lifetime of the trial, including recruitment, informed consent procedure, visit co-ordination and visit scheduling Support clinicians and research staff in maximising recruitment and follow up participation. Identify any barriers to effective recruitment and follow up, and seek solutions in conjunction with the other members of the research team. Deal promptly and efficiently with any queries, acknowledging all communication and ensuring efficient flow of information Plan and organise own and other administration staff workloads effectively and efficiently, completing tasks within tight time constraints. Decision Making Develop and implement a strategy for recruiting patients, identify barriers and strategies to overcome Responsible for identifying significant and critical risks/issues affecting the progress of the service, able to take immediate corrective action and communicate issues to the Clinical Stroke research lead in a timely and coherent fashion Responsible for identifying documentation, training and administrative requirements with respect to trial management, and contributing to these appropriately Monitor developments in the legal and regulatory frameworks for the conduct of clinical trials. Disseminate to appropriate staff and update project documentation appropriately Communication and Stakeholder Relationships Develop and maintain strong relationships with internal and external stakeholders Work closely and maintain excellent communication with the Clinical Stroke research lead, Investigators and the wider clinical team Establish and maintain good communications with colleagues, including clinicians, therapists, nurses etc. Ensure good channels of communication with other departments in the NHS and the university, as well as with external stakeholder Participate and represent service at local and national research meetings as appropriate e.g. South London Clinical Research Network and Hyperacute Stroke Research Centre (HSRC) committee meetings Provide a highly effective and responsive approach to problem resolution Provide regular feedback on the progress of the service including recruitment performance against targets Problem Solving Recognise and resolve issues within the areas of trial management, flagging critical issues to the Clinical Stroke research lead in a timely fashion. This will include reporting adverse incidents and near misses via the Trusts online incident reporting form (Datix) Proactively employ risk management techniques in project management, ensuring smooth flow of activity throughout Maintain proper documentation in line with Data Protection and Confidentiality laws, Good Clinical Practice and trust policies and guidelines. Adopt a proactive approach to workload management and problem solving, using initiative and judgement. Respond accordingly in the event a Corrective Action Prevention Action (CAPA) or Datix is raised for the service Travel and Job Demands The nature of the post may require regular working outside of normal office hours. The post holder should be open to undertaking flexible hours of work The work of the post may require attendance at meetings away from Kings College Hospital, including overnight stays Job description Job responsibilities Analysis and Research Work closely with other members of core the research team including Research Nurses, Research Coordinators and Research Administrator in data collection, providing training and on-going support Monitor data quality; and perform routine data cleaning, to achieve an accurate and complete dataset. Monitor online data entry, checking for inconsistencies, violations and adverse events Monitor the progress of research activities including preparation of periodic performance review and ad hoc reports as required by investigators, the wider research team, funding agencies and regulatory bodies Provide senior management with project status reports, advise on best project management practice and identify areas that need improvement Planning and Organising Work closely with Kings R&I and KHP CTO to optimise the study set up process Facilitate study set-up at participating sites; and continue to oversee the clinical operations throughout the lifetime of the trial, including recruitment, informed consent procedure, visit co-ordination and visit scheduling Support clinicians and research staff in maximising recruitment and follow up participation. Identify any barriers to effective recruitment and follow up, and seek solutions in conjunction with the other members of the research team. Deal promptly and efficiently with any queries, acknowledging all communication and ensuring efficient flow of information Plan and organise own and other administration staff workloads effectively and efficiently, completing tasks within tight time constraints. Decision Making Develop and implement a strategy for recruiting patients, identify barriers and strategies to overcome Responsible for identifying significant and critical risks/issues affecting the progress of the service, able to take immediate corrective action and communicate issues to the Clinical Stroke research lead in a timely and coherent fashion Responsible for identifying documentation, training and administrative requirements with respect to trial management, and contributing to these appropriately Monitor developments in the legal and regulatory frameworks for the conduct of clinical trials. Disseminate to appropriate staff and update project documentation appropriately Communication and Stakeholder Relationships Develop and maintain strong relationships with internal and external stakeholders Work closely and maintain excellent communication with the Clinical Stroke research lead, Investigators and the wider clinical team Establish and maintain good communications with colleagues, including clinicians, therapists, nurses etc. Ensure good channels of communication with other departments in the NHS and the university, as well as with external stakeholder Participate and represent service at local and national research meetings as appropriate e.g. South London Clinical Research Network and Hyperacute Stroke Research Centre (HSRC) committee meetings Provide a highly effective and responsive approach to problem resolution Provide regular feedback on the progress of the service including recruitment performance against targets Problem Solving Recognise and resolve issues within the areas of trial management, flagging critical issues to the Clinical Stroke research lead in a timely fashion. This will include reporting adverse incidents and near misses via the Trusts online incident reporting form (Datix) Proactively employ risk management techniques in project management, ensuring smooth flow of activity throughout Maintain proper documentation in line with Data Protection and Confidentiality laws, Good Clinical Practice and trust policies and guidelines. Adopt a proactive approach to workload management and problem solving, using initiative and judgement. Respond accordingly in the event a Corrective Action Prevention Action (CAPA) or Datix is raised for the service Travel and Job Demands The nature of the post may require regular working outside of normal office hours. The post holder should be open to undertaking flexible hours of work The work of the post may require attendance at meetings away from Kings College Hospital, including overnight stays Person Specification Education and Qualifications Essential Degree or equivalent education Higher degree - Masters or evidence of equivalent research independence or an equivalent level of work experience. Desirable Project management qualification or significant experience in a project / operational management role. Knowledge and Experience Essential Expert knowledge in the area of clinical trials and/or medical research projects, with a sound knowledge of Good Clinical Practice (GCP). Extensive experience in clinical research trials, with significant experience in project or clinical trials management. Experience in the development of key research related materials such as protocols, manuals of operation and standard operating procedures. Strong project / trials management capabilities. Experience in line management, including training staff Desirable Knowledge of trials IT/data management requirements, including paper/electronic data collection methods. Knowledge of quality management systems and processes. Experience in developing study applications for approval (e.g. regulatory, ethics, R&D, access to NHS datasets) Experience in study site setup, recruitment and co-ordination Experience in the provision of training. Experience in budget management Experience of research in stroke (or similar) Skills and Competencies Essential Strong project / trials management capabilities Excellent communication skills, both orally and in writing. Excellent organisational and co-ordinating skills. Excellent interpersonal and negotiating skills. Ability to cope under pressure while maintaining a high level of accuracy. Excellent analytical and problem-solving skills. Ability to work independently and under supervision, as appropriate, assessing priorities and managing own workload effectively. Reliable, trustworthy and able to maintain confidentiality. Flexible, committed and enthusiastic approach to work, with ability to work as part of a team with staff at all levels. Good computer skills in the area of project / trials management (e.g. database, spreadsheet, word processing, layout, presentation software). Ability to develop skills in response to technological change. Desirable Ability to develop skills in response to technological change. Person Specification Education and Qualifications Essential Degree or equivalent education Higher degree - Masters or evidence of equivalent research independence or an equivalent level of work experience. Desirable Project management qualification or significant experience in a project / operational management role. Knowledge and Experience Essential Expert knowledge in the area of clinical trials and/or medical research projects, with a sound knowledge of Good Clinical Practice (GCP). Extensive experience in clinical research trials, with significant experience in project or clinical trials management. Experience in the development of key research related materials such as protocols, manuals of operation and standard operating procedures. Strong project / trials management capabilities. Experience in line management, including training staff Desirable Knowledge of trials IT/data management requirements, including paper/electronic data collection methods. Knowledge of quality management systems and processes. Experience in developing study applications for approval (e.g. regulatory, ethics, R&D, access to NHS datasets) Experience in study site setup, recruitment and co-ordination Experience in the provision of training. Experience in budget management Experience of research in stroke (or similar) Skills and Competencies Essential Strong project / trials management capabilities Excellent communication skills, both orally and in writing. Excellent organisational and co-ordinating skills. Excellent interpersonal and negotiating skills. Ability to cope under pressure while maintaining a high level of accuracy. Excellent analytical and problem-solving skills. Ability to work independently and under supervision, as appropriate, assessing priorities and managing own workload effectively. Reliable, trustworthy and able to maintain confidentiality. Flexible, committed and enthusiastic approach to work, with ability to work as part of a team with staff at all levels. Good computer skills in the area of project / trials management (e.g. database, spreadsheet, word processing, layout, presentation software). Ability to develop skills in response to technological change. Desirable Ability to develop skills in response to technological change. Disclosure and Barring Service Check This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions. Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab). From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab). Additional information Disclosure and Barring Service Check This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions. Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab). From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab). Employer details Employer name King's College Hospital NHS Foundation Trust Address King's College Hospital NHS Foundation Trust Denmark Hill London SE5 9RS Employer's website https://www.kch.nhs.uk/ (Opens in a new tab)