Detailed job description and main 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 Trust’s research strategy and objectives.
• Ensure that the governance is robust and evolving in response to regulatory changes or best practices.
• Act as the Trust’s 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 Trust’s 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.