Special Requirements Travel to attend meetings (primarily UK occasionally EU) Willingness to work non-standard hours as reasonably required to fulfil the role Internal and external relationships Research Integrity & Governance Committee, University Ethics Committee ad Faculty Ethics Committee Associate Deans Research, Academic Integrity Officers Southampton Clinical Trials Unit, Clinical Research Facility and Human Tissue Act named licence holders and persons designate Home Office Licence holder and Animal Welfare and Ethical Review Board Professional Services - Legal Services, Library & colleagues in RIS Academic, Researchers and students Regulatory authorities MHRA, HRA, NRES and the Export Control Office – Funders especially NIHR and US Public Health Funders – NHS and Academic Collaborators in particular R&D personnel Other external: ARMA, UKRIO, AFRE, Russell Group Research Integrity Forum, local Clinical Research Networks PERSON SPECIFICATION Criteria Essential Desirable How to be assessed Qualifications, Skill level equivalent to Understanding and awareness knowledge & achievement of a professional of the wider regulatory Application/Interview experience qualification or postgraduate environment including:export degree. controls, anti-corruption and bribery. Proven experience of managing a research integrity and/or compliance function. Experience of the development Detailed knowledge of the of guidance and procedures in Research Integrity Concordat and response to compliance with of ethics and governance new regulations or funder standards. requirements. Expert knowledge of Research Governance Framework, Clinical Understanding of policies Trials legislation, Human Tissue applicable to Research and Act and Data Protection Act. Funder requirements including: Thorough understanding and Research Data Management, experience working in an conflicts of interest, security academic environment or with and defence Universities. Planning & Able to plan and manage new organising projects or significant new activities, ensuring plans complement broader organisational strategy. Problem Able to identify broad trends to solving & assess deep-rooted and complex initiative issues. Able to apply originality in modifying existing approaches to solve problems. Experience of analysing complex regulatory policy information quickly and accurately, and providing robust yet pragmatic solutions
Special Requirements Travel to attend meetings (primarily UK occasionally EU) Willingness to work non-standard hours as reasonably required to fulfil the role Internal and external relationships Research Integrity & Governance Committee, University Ethics Committee ad Faculty Ethics Committee Associate Deans Research, Academic Integrity Officers Southampton Clinical Trials Unit, Clinical Research Facility and Human Tissue Act named licence holders and persons designate Home Office Licence holder and Animal Welfare and Ethical Review Board Professional Services - Legal Services, Library & colleagues in RIS Academic, Researchers and students Regulatory authorities – MHRA, HRA, NRES and the Export Control Office Funders – especially NIHR and US Public Health Funders NHS and Academic Collaborators in particular R&D personnel Other external: ARMA, UKRIO, AFRE, Russell Group Research Integrity Forum, local Clinical Research Networks PERSON SPECIFICATION Criteria Essential Desirable How to be assessed Qualifications, knowledge & experience Skill level equivalent to achievement of a professional qualification or postgraduate degree. Proven experience of managing a research integrity and/or compliance function. Detailed knowledge of the Research Integrity Concordat and of ethics and governance standards. Expert knowledge of Research Governance Framework, Clinical Trials legislation, Human Tissue Act and Data Protection Act. Thorough understanding and experience working in an academic environment or with Universities. Understanding and awareness of the wider regulatory environment including:export controls, anti-corruption and bribery. Experience of the development of guidance and procedures in response to compliance with new regulations or funder requirements. Understanding of policies applicable to Research and Funder requirements including: Research Data Management, conflicts of interest, security and defence Application/Interview Planning & organising Able to plan and manage new projects or significant new activities, ensuring plans complement broader organisational strategy. Problem solving & initiative Able to identify broad trends to assess deep-rooted and complex issues. Able to apply originality in modifying existing approaches to solve problems. Experience of analysing complex regulatory policy information quickly and accurately, and providing robust yet pragmatic solutions