Job description & person specification Last updated: 04 September 2015 JOB DESCRIPTION Post title: Research Integrity Officer (Policy and Ethics) Academic Unit/Service: Research and Innovation Services Faculty: - Career pathway: MSA Level: 4 *ERE category: Posts responsible to: Research Integrity & Governance Manager Posts responsible for: Post base: Office-based Job purpose To provide specialist advice and guidance on all matters relating to achieving and maintaining compliance with the Research Integrity Concordat and the sometimes complex legal requirements applicable to research. Support to furthering the University’s commitment to meeting the highest ethical and integrity standards. Take a leading role in the implementation of relevant University Policies and development of information resources to ensure best practice and understanding amongst staff of the ethical requirements (beyond human participation and animal research). To provide expert guidance and support to internal and external stakeholders throughout the compliance reporting process and for obtaining necessary approvals, licences, registrations and certifications. Key accountabilities/primary responsibilities 1. % Time Responsible for providing advice and guidance on a breadth of ethics issues in relation to 20 cultural and social sensitive, environmental, security and defence research, including: Using expert knowledge to resolve queries in a timely and professional manner. Provide robust yet proportionate guidance in relation to category of risk applicable to the research. Support and advice to Faculties and Faculty Ethics Committee members to further consistent and harmonised approach across the University Support to researchers on applications for ethics review using the University’s ethics and governance systems including ERGO (www.ergo.soton.ac.uk). Contribute to the development and maintenance of all policies, processes, and systems (including ERGO). Design and undertaken a compliance assessment plan to check compliance with University Ethics Policy, and current ethical approvals Key accountabilities/primary responsibilities 2. % Time Design a review programme for quality of ethical reviews and approvals given providing recommendations and guidance to achieve improvement Provide advice and guidance to staff in relation to a range of policies & codes applicable to research and enterprise including Code of Conduct for researchers Conflicts of Interests, Research Integrity, Procedures for investigation or research misconduct, Export controls and Dual Use Support on applications and amendments for licences, permissions and other registrations Apply specialist knowledge of the online approval systems used (e.g. Spire for ECO) 20 3. Coordinate and contribute to the development, maintenance and implementation of policies and codes described in section 2 above. Provide expert input and advice to the development of research and enterprise policies lead outside of the RIG Team to ensure consistency and harmonised approach across the University. 10 4. Take a leading role in relation to management and reporting of complaints and allegations of research misconduct 15 Develop and implement a system to track and manage complaints and allegations of misconduct Work closely with HR and Faculties to ensure status and outcomes of any investigations are recorded Report on a project/incident basis as necessary to Funders and external bodies Report in accordance with Research Integrity Concordat Communicate with complainants Provide input to institutional and project audits 5. Develop and deliver a training programme and awareness raising campaign promoting understanding of the University research and enterprise policies, regulatory compliance and ethical review process to all staff and students including to FEC members, and Supervisors. 15 6. Maintaining an up-to date intranet resource of information for all staff on all aspects of Research Integrity, the research and enterprise policies and relevant regulatory requirements. Develop and maintain publically facing web pages to promote the University’s record and progress towards compliance with the Research Integrity Concordat and the quality of University research. 10 7. Maintain a strong awareness of regularly changing policy and wider governance environment by working with a range of external stakeholders. Alert senior management to changes which may impact upon University guidance or procedures. 5 8. Work cooperatively and effectively in the RIG Team and more widely in RIS 5 9. Deputising where necessary for RIG Manager on matters within expertise Providing continuity and advice where possible in absence of RIG colleagues Mentoring and support to Research Governance Officer Advice and support to Faculty based RIS staff especially Research Support Officers supporting ethics reviews Any other duties as allocated by the line manager following consultation with the post holder. Document1 2 Special Requirements Travel to attend meetings (primarily UK occasionally EU) Internal and external relationships RIG Team and wider RIS team Academics, researchers and students Faculty Ethics Committee members and Academic Integrity Officers Legal Services – especially Data Protection Officer Communication & Marketing Regulatory Authorities – Export Control Office NHS and Academic Collaborators in particular R&D personnel Funders – RCUK UKRIO, AFRE & ARMA Document1 3 PERSON SPECIFICATION Criteria Essential Desirable How to be assessed Qualifications, knowledge & experience Skill level equivalent to achievement of HND, Degree, NVQ4 or basic professional qualification. Understanding of the ethical and regulatory approvals applicable to clinical research. Application/Interview Regulatory compliance, legal qualification or equivalent experience. Experience in applying for or supporting applications for NRES, MHRA and other approvals applicable to clinical trials regulation and governance requirements. In depth appreciation of how to identify actual or potential conflicts of interest and strategies Knowledge and understanding to assist with managing the same. of relevant legislation including Human Tissue Act, Data Detailed knowledge and Protection Act, EU Clinical Trials understanding of Research Directive, Good Clinical Practice Integrity Concordat (GCP) and any other legislation Understanding of export controls, which could influence and dual use and security sensitive affect the conduct of research research issues. Demonstrable understanding and experience of best practice in relation to the development of an ethical review process which is proportionate to different types and risk categories of research. Experience working in a research intensive University and/or an NHS research support role. Planning & organising Able to seek opportunities to progress a broad range of activities within professional guidelines and in support of University policy. Experience in coordinating and undertaking a programme of monitoring and compliance checking activity Experience of successful project management. Problem solving & initiative Experience of analysing complex regulatory policy information quickly and accurately, and providing robust yet pragmatic solutions. Management & teamwork Able to proactively work with colleagues in other work areas to achieve outcomes. Able to provide expert guidance and advice to colleagues to resolve complex problems. Able to delegate effectively in a matrix working environment, understanding the strengths and weaknesses of team members to build effective teamwork. Document1 4 Communicating Able to persuade and influence in & influencing order to foster and maintain relationships. Able to resolve tensions and difficulties as they arise. Able to explain complex regulatory and policy information and presenting in an appropriate format for target audience Other skills & behaviours Special requirements Document1 5 JOB HAZARD ANALYSIS Is this an office-based post? ☒ Yes If this post is an office-based job with routine office hazards (eg: use of VDU), no further information needs to be supplied. Do not complete the section below. ☐ No If this post is not office-based or has some hazards other than routine office (eg: more than use of VDU) please complete the analysis below. Hiring managers are asked to complete this section as accurately as possible to ensure the safety of the post-holder. ## - HR will send a full PEHQ to all applicants for this position. Please note, if full health clearance is required for a role, this will apply to all individuals, including existing members of staff. ENVIRONMENTAL EXPOSURES Occasionally Frequently Constantly (<30% of time) (30-60% of time) (> 60% of time) Outside work Extremes of temperature (eg: fridge/ furnace) ## Potential for exposure to body fluids ## Noise (greater than 80 dba - 8 hrs twa) ## Exposure to hazardous substances (eg: solvents, liquids, dust, fumes, biohazards). Specify below: Frequent hand washing Ionising radiation EQUIPMENT/TOOLS/MACHINES USED ## Food handling ## Driving university vehicles(eg: car/van/LGV/PCV) ## Use of latex gloves (prohibited unless specific clinical necessity) ## Vibrating tools (eg: strimmers, hammer drill, lawnmowers) PHYSICAL ABILITIES Load manual handling Repetitive crouching/kneeling/stooping Repetitive pulling/pushing Repetitive lifting Standing for prolonged periods Repetitive climbing (ie: steps, stools, ladders, stairs) Fine motor grips (eg: pipetting) Gross motor grips Repetitive reaching below shoulder height Repetitive reaching at shoulder height Repetitive reaching above shoulder height PSYCHOSOCIAL ISSUES Face to face contact with public Lone working ## Shift work/night work/on call duties Document1 6