Job summary
The post holder will take responsibility for the operational management of the R&I Central Office (RICO) and CTU Office (CTUO). This includes, but is not limited to, the set-up and ongoing management of research projects both commercial and non-commercial, development of new projects, audit and monitoring, governance and regulatory oversight, sponsorship, risk management, quality assurance and inspection readiness.
The post holder will proactively review, update and develop processes and procedures to continually improve the service and support the R&I/CTU Manager in achieving the departments strategic aims and objectives.
The post holder will deputise for the R&I/CTU Manager.
Main duties of the job
Leadership and management
Lead on research governance
Provide a supportive and caring environment
Operational management of research set up and ongoing management
Training, Development and leadership
Monitoring, audit and risk assessment
Stakeholder engagement and communication
Continuous improvement and knowledge sharing
Deputising for R&I/CTU Manager
About us
We are one of the largest hospital trusts in England, with five hospitals and community clinics serving a local population of around 800,000 people. Our vision is 'great healthcare from great people'. Everything we do is guided by our values: 'People feel cared for, safe, respected and confident that we are making a difference'. We have a new way of working at East Kent Hospitals, called 'We care'. It's about empowering frontline staff to lead improvements day-to-day. We're looking for compassionate people to be part of our improvement journey for the patients, families and carers we care for every day.
Please note that if you require a Certificate of Sponsorship to work in the UK you must declare this on your application form, even if you currently have a certificate of sponsorship or a work permit for another role and are already working in the country. Please note we are only able to sponsor candidates on a Skilled Worker Visa applying for roles Band 5 and above.
Job description
Job responsibilities
1.Leadership and Oversight of Research Governance
- Lead on research governance, ensuring all research activities comply with relevant regulatory requirements, including national guidelines and local policies.
- Ensure adherence to ethical standards, including the Health Research Authority (HRA) regulations, Research Ethics Committees (REC), and Good Clinical Practice (GCP).
- Provide operational leadership to Research and Innovation Central Office (RICO) and Clinical Trials Unit Office (CTUO), ensuring alignment with the Trusts research strategy and objectives.
- Ensure that the governance is robust and evolving in response to regulatory changes or best practices.
- Act as the Trusts main point of contact for issues related to research governance, offering expert guidance to both staff and stakeholders.
2. Audit, Monitoring, and Risk Management
- Develop, implement, and oversee a comprehensive audit and monitoring plan for both hosted and sponsored research studies, ensuring that all relevant studies are appropriately risk-assessed.
- Collaborate with research teams to ensure the timely identification and mitigation of risks throughout the study lifecycle.
- Ensure that risk assessments are thoroughly documented and reviewed regularly to maintain the integrity of research projects and ensure compliance with the ethical and regulatory frameworks.
- Conduct periodic audits and inspections of research sites and processes to ensure ongoing compliance with governance requirements and standards.
3. Research Set-Up and Management
- Oversee and manage the capacity and capability process for all new research studies, ensuring the Trust can meet the demands of the projects while maintaining the integrity of research governance.
- Ensure the timely and efficient setup of studies, addressing any obstacles or challenges that arise during the planning and approval stages.
- Develop and maintain strong relationships with support departments to streamline and improve processes associated with research study setup and execution.
- Liaise closely with the Clinical Research Facility (CRF) in Margate, ensuring that studies planned for delivery in the CRF are properly set up and facilitating collaboration between the CRF and other clinical departments.
- Review and prepare model contracts, collaboration agreements and other agreements, ensuring that these documents are ready for authorisation by the R&I/CTU Manager.
- Work proactively to identify any potential delays or issues in the research setup process, implementing strategies to overcome challenges and maintain project timelines.
4. Team Management and Development
- Provide clear leadership and line management to the R&I office staff and CTU office staff, ensuring that all team members have a clear understanding of their roles, responsibilities, and performance expectations.
- Set individual and team objectives, ensuring that everyone is accountable for their work and is working towards the Trusts overarching research goals.
- Foster a collaborative, positive, and solution-focused team culture that encourages continuous development, knowledge sharing, and innovation.
- Oversee the recruitment, induction, and development of new research staff, ensuring that all new team members are integrated smoothly into the department and equipped with the necessary skills and knowledge to perform effectively.
- Identify opportunities for professional development, supporting staff to enhance their skills in areas such as research governance, GCP, and ethical conduct of research.
- Ensure that all necessary ESR and HR documentation for direct reports is complete, including performance appraisals, training records, and HR-related paperwork.
5. Training and Compliance
- Coordinate and deliver training programs for research staff to ensure that all team members are proficient in research governance, ethical practices, and compliance with regulations such as GCP.
- Provide staff with opportunities to attend workshops, seminars, and conferences to enhance their understanding of research governance and regulatory updates.
- Ensure that all research-active staff are appropriately trained and certified in GCP, monitoring attendance at training sessions and ensuring that qualifications are up-to-date.
- Collaborate with research delivery teams to assess and fulfil training needs, ensuring the continuous professional development of all research staff across the Trust.
6. Stakeholder Engagement and Communication
- Engage with external partners, including research sponsors, academic collaborators, and regulatory bodies, to ensure smooth study initiation, progression, and closure.
- Communicate key developments, regulatory changes, and research findings to stakeholders across the organisation, ensuring clarity and transparency in all communications related to research governance.
- Develop and maintain a communication strategy for sharing research progress, outcomes, and impact with both internal and external stakeholders.
7. Continuous Improvement and Knowledge Sharing
- Foster a culture of continuous improvement within the research team, encouraging feedback and innovative ideas to enhance operational processes.
- Maintain a thorough and up-to-date knowledge of research policy, emerging regulatory guidelines, and best practices by regularly attending workshops, training sessions, and conferences.
- Disseminate relevant research policy updates, best practices, and regulatory changes to the research team and other relevant stakeholders to ensure that the Trust remains compliant with the latest standards.
- Identify opportunities to streamline processes, reduce inefficiencies, and improve the overall research experience for staff and participants alike.
8. Deputising Responsibilities
- Deputise for the R&I Manager in their absence, ensuring the continuity of operations and leadership within the department.
- Take responsibility for the overall management of research governance processes, maintaining strategic oversight of all research activities in the Trust.
- Act as the decision-maker in the absence of the R&I Manager, particularly in critical or time-sensitive situations.
Analytical and Judgement
Judgements involving complex facts or situations, which require the analysis, interpretation, and comparison of a range of options.
Job description
Job responsibilities
1.Leadership and Oversight of Research Governance
- Lead on research governance, ensuring all research activities comply with relevant regulatory requirements, including national guidelines and local policies.
- Ensure adherence to ethical standards, including the Health Research Authority (HRA) regulations, Research Ethics Committees (REC), and Good Clinical Practice (GCP).
- Provide operational leadership to Research and Innovation Central Office (RICO) and Clinical Trials Unit Office (CTUO), ensuring alignment with the Trusts research strategy and objectives.
- Ensure that the governance is robust and evolving in response to regulatory changes or best practices.
- Act as the Trusts main point of contact for issues related to research governance, offering expert guidance to both staff and stakeholders.
2. Audit, Monitoring, and Risk Management
- Develop, implement, and oversee a comprehensive audit and monitoring plan for both hosted and sponsored research studies, ensuring that all relevant studies are appropriately risk-assessed.
- Collaborate with research teams to ensure the timely identification and mitigation of risks throughout the study lifecycle.
- Ensure that risk assessments are thoroughly documented and reviewed regularly to maintain the integrity of research projects and ensure compliance with the ethical and regulatory frameworks.
- Conduct periodic audits and inspections of research sites and processes to ensure ongoing compliance with governance requirements and standards.
3. Research Set-Up and Management
- Oversee and manage the capacity and capability process for all new research studies, ensuring the Trust can meet the demands of the projects while maintaining the integrity of research governance.
- Ensure the timely and efficient setup of studies, addressing any obstacles or challenges that arise during the planning and approval stages.
- Develop and maintain strong relationships with support departments to streamline and improve processes associated with research study setup and execution.
- Liaise closely with the Clinical Research Facility (CRF) in Margate, ensuring that studies planned for delivery in the CRF are properly set up and facilitating collaboration between the CRF and other clinical departments.
- Review and prepare model contracts, collaboration agreements and other agreements, ensuring that these documents are ready for authorisation by the R&I/CTU Manager.
- Work proactively to identify any potential delays or issues in the research setup process, implementing strategies to overcome challenges and maintain project timelines.
4. Team Management and Development
- Provide clear leadership and line management to the R&I office staff and CTU office staff, ensuring that all team members have a clear understanding of their roles, responsibilities, and performance expectations.
- Set individual and team objectives, ensuring that everyone is accountable for their work and is working towards the Trusts overarching research goals.
- Foster a collaborative, positive, and solution-focused team culture that encourages continuous development, knowledge sharing, and innovation.
- Oversee the recruitment, induction, and development of new research staff, ensuring that all new team members are integrated smoothly into the department and equipped with the necessary skills and knowledge to perform effectively.
- Identify opportunities for professional development, supporting staff to enhance their skills in areas such as research governance, GCP, and ethical conduct of research.
- Ensure that all necessary ESR and HR documentation for direct reports is complete, including performance appraisals, training records, and HR-related paperwork.
5. Training and Compliance
- Coordinate and deliver training programs for research staff to ensure that all team members are proficient in research governance, ethical practices, and compliance with regulations such as GCP.
- Provide staff with opportunities to attend workshops, seminars, and conferences to enhance their understanding of research governance and regulatory updates.
- Ensure that all research-active staff are appropriately trained and certified in GCP, monitoring attendance at training sessions and ensuring that qualifications are up-to-date.
- Collaborate with research delivery teams to assess and fulfil training needs, ensuring the continuous professional development of all research staff across the Trust.
6. Stakeholder Engagement and Communication
- Engage with external partners, including research sponsors, academic collaborators, and regulatory bodies, to ensure smooth study initiation, progression, and closure.
- Communicate key developments, regulatory changes, and research findings to stakeholders across the organisation, ensuring clarity and transparency in all communications related to research governance.
- Develop and maintain a communication strategy for sharing research progress, outcomes, and impact with both internal and external stakeholders.
7. Continuous Improvement and Knowledge Sharing
- Foster a culture of continuous improvement within the research team, encouraging feedback and innovative ideas to enhance operational processes.
- Maintain a thorough and up-to-date knowledge of research policy, emerging regulatory guidelines, and best practices by regularly attending workshops, training sessions, and conferences.
- Disseminate relevant research policy updates, best practices, and regulatory changes to the research team and other relevant stakeholders to ensure that the Trust remains compliant with the latest standards.
- Identify opportunities to streamline processes, reduce inefficiencies, and improve the overall research experience for staff and participants alike.
8. Deputising Responsibilities
- Deputise for the R&I Manager in their absence, ensuring the continuity of operations and leadership within the department.
- Take responsibility for the overall management of research governance processes, maintaining strategic oversight of all research activities in the Trust.
- Act as the decision-maker in the absence of the R&I Manager, particularly in critical or time-sensitive situations.
Analytical and Judgement
Judgements involving complex facts or situations, which require the analysis, interpretation, and comparison of a range of options.
Person Specification
Qualifications and training
Essential
- Degree in a relevant scientific, clinical, or healthcare-related field (or equivalent experience).
- Good Clinical Practice (GCP) certification.
Desirable
- Postgraduate qualification in research, project management, or a related field
- Relevant professional certification in research governance or clinical trials.
- Leadership /Management qualification
- GCP Facilitator
Skills and experience
Essential
- Minimum 4 years experience in research
- Significant experience in clinical research or research governance.
- Significant experience in a research or clinical trials environment, preferably within the NHS
- Experience of the set-up, management, and/or delivery of clinical research or clinical trials.
- Familiarity with research ethics, good clinical practice (GCP), and NHS research governance frameworks
- Experience working with external stakeholders such as academic institutions, research sponsors, and industry partners.
- Demonstrable experience in managing and leading teams, preferably in a research or healthcare setting.
- Ability to use research databases and reporting systems effectively.
- Undertaking monitoring/audit or equivalent
- Excellent IT skills including Office Packages
- Attention to detail
- Flexible and adaptable
Desirable
- Experience in the operational management of research projects within the NHS.
- Experience in strategic planning and implementing research strategies.
- Knowledge of research funding sources and grant management.
Personal/professional attributes
Essential
- Excellent leadership and team management skills, with the ability to motivate, support, and develop staff
- Fair and democratic people skills encouraging openness, trust, and collaboration.
- High level of attention to detail and accuracy, particularly with documentation and compliance.
- Ability to work under pressure and manage complex and time-sensitive projects.
- Excellent interpersonal skills, with the ability to build relationships across multidisciplinary teams.
- Demonstrated ability to work autonomously and manage competing priorities.
- Ability to establish and maintain effective communication with individuals and groups about difficult and complex issues, overcoming any difficulties.
- A proactive approach to identifying and addressing issues.
Desirable
- A passion for advancing research and innovation in healthcare.
Other requirements
Essential
- Able to instil and emulate Trust values
Person Specification
Qualifications and training
Essential
- Degree in a relevant scientific, clinical, or healthcare-related field (or equivalent experience).
- Good Clinical Practice (GCP) certification.
Desirable
- Postgraduate qualification in research, project management, or a related field
- Relevant professional certification in research governance or clinical trials.
- Leadership /Management qualification
- GCP Facilitator
Skills and experience
Essential
- Minimum 4 years experience in research
- Significant experience in clinical research or research governance.
- Significant experience in a research or clinical trials environment, preferably within the NHS
- Experience of the set-up, management, and/or delivery of clinical research or clinical trials.
- Familiarity with research ethics, good clinical practice (GCP), and NHS research governance frameworks
- Experience working with external stakeholders such as academic institutions, research sponsors, and industry partners.
- Demonstrable experience in managing and leading teams, preferably in a research or healthcare setting.
- Ability to use research databases and reporting systems effectively.
- Undertaking monitoring/audit or equivalent
- Excellent IT skills including Office Packages
- Attention to detail
- Flexible and adaptable
Desirable
- Experience in the operational management of research projects within the NHS.
- Experience in strategic planning and implementing research strategies.
- Knowledge of research funding sources and grant management.
Personal/professional attributes
Essential
- Excellent leadership and team management skills, with the ability to motivate, support, and develop staff
- Fair and democratic people skills encouraging openness, trust, and collaboration.
- High level of attention to detail and accuracy, particularly with documentation and compliance.
- Ability to work under pressure and manage complex and time-sensitive projects.
- Excellent interpersonal skills, with the ability to build relationships across multidisciplinary teams.
- Demonstrated ability to work autonomously and manage competing priorities.
- Ability to establish and maintain effective communication with individuals and groups about difficult and complex issues, overcoming any difficulties.
- A proactive approach to identifying and addressing issues.
Desirable
- A passion for advancing research and innovation in healthcare.
Other requirements
Essential
- Able to instil and emulate Trust values
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.
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.
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).
