This post is based in the Joint Research and Development (R&D) Office of Great Ormond Street Hospital (GOSH) and the UCL Inst.....
This post is based in the Joint Research and Development (R&D) Office of Great Ormond Street Hospital (GOSH) and the UCL Institute of Child Health (ICH). The Joint R&D Office is responsible for all R&D governance, administration and research management, holding comprehensive data on all clinical and non-clinical research taking place across both organisations. The Joint R&D Office provides a number of services including the provision of advice and support on research governance, ethical approval, data protection, a comprehensive grants advice service, advising on commercially sponsored research, and the management of Intellectual Property (IP). Reporting to the Head of R&D. The post holder will lead the provision of a high quality service with respect to research and knowledge exchange contracts and a wide range of related agreements. This will require extension liaison with internal stakeholders (academic colleagues, research and business development teams, senior managers) and a wide range of external partners (including funders, collaborators and regulatory bodies) to propose, review, adapt and negotiate a required a wide range of agreements for research studies at GOSH/ ICH, these include funding agreements, studentship, research collaboration agreements clinical trial agreements, confidentiality agreements, material transfer agreements and subcontracts including contract amendments. Professionally responsible for own workload and works autonomously/work autonomously without access to higher internal legal services Undertake thorough reviews of research protocols, to analyse and make definite judgements on the activity and resource requirements based on information which will be highly complex. Liaise with senior clinical academics and senior managers in finance to discuss cost and operational implications, for example advising on service commitments. Liaise with Finance teams to ensure the budgets for inclusion in contracts are appropriate and cover costs of work carried out. Contribute to drawing up of research study budgets and clarifying costing model to research staff Negotiate and agree contractual and financial terms on commercial and non-commercial contracts with, senior research staff, pharmaceutical companies, Contract Research Organisations (CROs), Universities and NHS Trusts ensuring that appropriate measures and terms are in place to protect the Trusts interests. This will include management of legal and financial risks, enabling future research and teaching activity and management of Trust assets e.g. intellectual property. You will ensure that risks are acceptable and understood and secure the best possible outcome for the Trust. Negotiate with NHS and University partners to set-up and agree terms of non-commercial contracts Identify the appropriate type of contract required for new projects: e.g. confidentiality agreements, material transfer agreements, research funding; data registry; clinical trial; medical device research agreements, data sharing agreements and subcontracts Identify and reduce wherever possible any potential liabilities to the Trust and University under research and development connected contracts Organise and attend study and Principal Investigator meetings prior to contract set-up: To provide guidance and support to R&D governance team members on all aspects of contracts as necessary. Update contracts tracker on status of contracts Update IP tracker on status of IP agreements/cases The post holder will engage with a range of complex materials regarding contracts and research integrity and communicate effectively to explain the impact on University and Trust business to a range of audiences. To make judgements in relation to legal practice in research, negotiating on complex matters such as liabilities, warranties and ownership of data and intellectual property. The postholder will contribute to and work within a framework of practice agreed with the University and Trust, provide advice, guidance and recommendations to academic staff and colleagues, including senior managers, on issues including acceptable risks, intellectual property and project management: a) Review and make decisions on the appropriateness of contracts for any given project. b) Prepare and make recommendations for the signature of agreements. c) Keep database and other records up to date to ensure that there is a full record of negotiations and agreements. d) Review the terms and conditions of grant funders to ensure appropriate financial terms are included in agreements, seeking to negotiate with funders improved terms and conditions as appropriate. e) Liaise with colleagues in the R&D Office and in other Trust or University departments to develop and ensure that appropriate protocols and regulations are in place in contracts. f) Identify the appropriate type of contract to use for different scenarios, and draft bespoke contracts as necessary. g) Ensure that contracts comply with all internal and external policy and legal requirements, negotiating and amending as required. h) Lead on ensuring that academic and professional services staff understand their contractual obligations are understood and complied with The postholder will lead on work to continuously improve the contracting function of the R&D Office, including innovations in processes, workflows, tools. The postholder will also lead on the review and modernisation of the agreed framework of practice for research and knowledge exchange contracts and other legal agreements. As part of this they will be required to network with colleagues within the Trust, University and across the research sector. The postholder will be the first point of contact for a range of external bodies with respect to research contracts and will take a lead on communicating relevant information to team members, researchers, and managers. As part of this they will need to liaise with and organise internal stakeholders to ensure that contractual risks are understood and that strategies to ensure compliance are developed and agreed. To lead on provision of quarterly reports on new contracts successfully negotiated to the Head of R&D. Head of Governance and Clinical Trials and Director of Research & Innovation. Processes and Procedure Take the lead on developing and reviewing standard operating procedure for contracts management and cost recovery. Responsible for contributing to and implementation of departmental and where necessary organisation policies and proposes and implement changes to legal team which may impact beyond own area of activity such as procurement contracts for research. Communication and Collaboration Advise researchers on research processes and procedures. Advise staff of their responsibilities under the UK Policy Framework for Health and Social Care and the Good Clinical Practice compliance Exchange verbal and written information concerning legal documents and proceedings to researchers, legal staff at contracting sites. Communicate financial arrangement details, to legal staff at contracting site and other organisations. Maintain absolute confidentiality regarding sensitive personnel, financial and commercial information Develop excellent working relationships with Intellectual Property Providers, External Colleagues and senior colleagues within GOSH and UCL To lead on writing material/articles for the R&D Bulletin, external website, R&D leaflets as necessary relating to research contracting. Complete Research Governance reviews for commercial projects: i) Ensuring appropriate regulatory and ethical approvals are in place. ii) Tracking the status of studies from pre-approval to completion and ensuring that all study details are entered on to local database as required. iii) Review and advise on substantial amendments for research projects, these may also require the set-up contract amendments. Line Management Fully line manage the Research Contracts Associate/Officer providing full Human Resource support activities including staff induction, objective setting, training and development, managing performance, annual leave and sickness absence. Day to day supervision /management of other members of legal team; provides specialist training to NHS clinical and non-clinical staff on aspects of law e.g. on medical negligence, litigation claims and employment law. Other Duties will include Lead on maintaining effective working relationships between Sponsors and Clinical Research Organisations (CROs) and other collaborators to ensure contract negotiations and study set up time is minimal Lead on provision of data and project information to the NIHR to ensure our contractual requirements are met The post holder will be required to work on specific projects and undertake other administrative duties as required such as during the preparation of a MHRA inspection and other internal or external audits. Lead on playing an active part in the R&D team within GOSH/ICH by supporting and enforcing collaboration between the various team members. Training Undertake ongoing professional development to maintain and extend knowledge in relation to contracting and health-related research legislation and guidelines, and advise those responsible accordingly. You will also be required to disseminate knowledge to colleagues, including via the delivery of training on the application of the Universitys research contracts framework. Propose and implements changes to contract services for own area of activity
