Job summary
The GOSH and ICH Joint Research & Development Office manage a large, internationally recognised portfolio of research activity. The focus is on translational and clinical research - taking advances in basic medical research out of the laboratory and into the clinical setting to directly benefit patient care
Reporting to the Head of R&D, a talented individual is sought to help provide legal advice to R&D and researchers; prepare and manage a wide range of agreements connected to biomedical research including but not limited to commercial research. A strong understanding of the legal considerations regarding clinical research in the NHS and the ability to enter into high level negotiations with research collaborators and sponsors, including pharmaceutical companies, charities and universities, are key qualities required for this post holder
A self-starter, you will have excellent organisational skills with a proven understanding of research contracts. You will also be pragmatic and have proven ability to communicate effectively with senior clinicians, academic staff and other health service professionals to help deliver this challenging agenda within a dynamic multi-disciplinary environment.
The post holder will be required to maintain a good working relationship and a high level of customer service with R & D teams and external stakeholders.
For further details/informal visits contact: Dr Vanshee Patel, Head of Research and Development
vanshree.patel@gosh.nhs.uk
07395 852101
Main duties of the job
The post holder will provide legal advice to the Trust and review, draft and amend as required a wide range of agreements connected to biomedical research carried out at ICH and GOSH, including but not limited to commercial research (e.g. contractual and financial terms), non-commercial research (e.g. site agreements, model non-commercial agreements; drug supply agreements, material/data transfer agreements), Confidentiality Agreements, Human Tissue Act clauses and Material Transfer Agreements, Data Protection Act clauses within agreements,
The post holder will provide a dedicated service for commercial and non-commercial research activity taking place in GOSH and ICH that ensures good governance and management of risk in an extensive and complex research portfolio, while working in partnership with project teams, providing highly valued expertise and a focus on finding solutions in pursuit of shared goals. They will be responsible for understanding research protocols and making judgments on the level of activity and resource requirements at GOSH/ICH to determine the level of funding required from a commercial sponsor, as well as providing operational management and performance monitoring of commercial contracts. They will work closely with researchers in developing commercial research collaborations providing expert knowledge and advice and will work to targeted set up times as part of the overall research project approval.
About us
GOSH is committed to recruiting the best person for the job, based solely on their ability and individual merit as measured against the criteria for the role; through a process that is fair, open, consistent and free from bias and discrimination.
We are committed to being a diverse and inclusive employer and foster a culture where all staff are valued, respected and acknowledged. All applicants will receive consideration for employment without regard to race, colour, national origin, religion, sexual orientation, gender, gender identity, age, disability status or length of time spent unemployed.
We particularly welcome applications from BAME communities, people with disabilities and/or long-term health conditions and LGBT+ community members.
We have policies and procedures in place to ensure that all applicants and employees are treated fairly and consistently. We are proud to be accredited as a Disability Confident Employer, a member of Business Disability Forum and a Stonewall Diversity Champion.
We have active and Executive supported BAME, LGBT+ and Allies, Disability and Long-Term Health Conditions and Women's staff networks. Staff networks are employee-led groups formed around interests, issues and a common bond or background. Staff network members create a positive and inclusive work environment at Great Ormond Street Hospital by actively contributing to the Trust's mission, values and efforts specific to inclusion. All of our staff networks are open to any employee.
Job description
Job responsibilities
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
Job description
Job responsibilities
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
Person Specification
Academic/Professional qualification/Training
Essential
- A First Degree in law or an appropriate professional qualification or knowledge of legal procedures and contracts gained through experience
- Formal legal qualification at postgraduate level
- Professional training or qualification in Research Management or Contract Management
GOSH Culture and Values
Essential
- Our Always values oAlways welcoming oAlways helpful oAlways expert oAlways one team
Knowledge and Experience
Essential
- Sound knowledge of contract law. Knowledge of associated research contracts and clinical trial issues such as costs, governance, intellectual property, publication, confidentiality, VAT, indemnities, liabilities etc. and issues surrounding the market place
- Proven ability to understand and interpret complex contract documentation and financial terms and conditions
- Experience of managing expectations
Desirable
- Experience of working in NHS research, academic, financial or legal environment
- Experience of summarising complex research projects for internal publications
- Experience of collaborating with external agencies and organisations
Skills and Abilities
Essential
- Excellent IT skills in Microsoft Packages, especially use of Excel to produce calculations and MS
- High level of numeracy skills
- Excellent organisational and planning skills including proven ability to organise and prioritise workload (of self and team), work efficiently and meet tight deadlines. Assist in development of service provision through advice to researchers and managers.
- Excellent oral and written communication skills including communicating complex information to non-specialists
GOSH Culture and Values
Essential
- Knowledge and Understanding of diverse backgrounds and perspectives.
- Understanding of Diversity and Inclusion challenges in the workplace.
- 3)Demonstrable contribution to advancing Equality, Diversity and Inclusion in the Workplace
Knowledge and Experience
Essential
- Knowledge and experience of working with research contracts and legal agreements, in particular the review, drafting and amendment of such agreements.
- Knowledge of the Medicines for Human Use (Clinical Trials) Regulations; Data Protection Act; Human Tissue Act; UK Policy Framework for Health and Social Care Research
- Knowledge and understanding of the research approval process, the legislation governing research, clinical trials set up and pharmaceutical company requirements
- Experience of liaising with staff from a range of organisations and at different grades
Desirable
- Experience of line management of staff
Skills and Abilities
Essential
- Substantial negotiations skills, able to demonstrate success across a wide range of disciplines and levels
- Working with high levels of accuracy and with attention to detail
- Ability to analyse and rationalize research information. Ability to make complex decisions
- Ability to work independently and proactively and as part of a team and to fit in with the demands of a busy, open-plan office.
Person Specification
Academic/Professional qualification/Training
Essential
- A First Degree in law or an appropriate professional qualification or knowledge of legal procedures and contracts gained through experience
- Formal legal qualification at postgraduate level
- Professional training or qualification in Research Management or Contract Management
GOSH Culture and Values
Essential
- Our Always values oAlways welcoming oAlways helpful oAlways expert oAlways one team
Knowledge and Experience
Essential
- Sound knowledge of contract law. Knowledge of associated research contracts and clinical trial issues such as costs, governance, intellectual property, publication, confidentiality, VAT, indemnities, liabilities etc. and issues surrounding the market place
- Proven ability to understand and interpret complex contract documentation and financial terms and conditions
- Experience of managing expectations
Desirable
- Experience of working in NHS research, academic, financial or legal environment
- Experience of summarising complex research projects for internal publications
- Experience of collaborating with external agencies and organisations
Skills and Abilities
Essential
- Excellent IT skills in Microsoft Packages, especially use of Excel to produce calculations and MS
- High level of numeracy skills
- Excellent organisational and planning skills including proven ability to organise and prioritise workload (of self and team), work efficiently and meet tight deadlines. Assist in development of service provision through advice to researchers and managers.
- Excellent oral and written communication skills including communicating complex information to non-specialists
GOSH Culture and Values
Essential
- Knowledge and Understanding of diverse backgrounds and perspectives.
- Understanding of Diversity and Inclusion challenges in the workplace.
- 3)Demonstrable contribution to advancing Equality, Diversity and Inclusion in the Workplace
Knowledge and Experience
Essential
- Knowledge and experience of working with research contracts and legal agreements, in particular the review, drafting and amendment of such agreements.
- Knowledge of the Medicines for Human Use (Clinical Trials) Regulations; Data Protection Act; Human Tissue Act; UK Policy Framework for Health and Social Care Research
- Knowledge and understanding of the research approval process, the legislation governing research, clinical trials set up and pharmaceutical company requirements
- Experience of liaising with staff from a range of organisations and at different grades
Desirable
- Experience of line management of staff
Skills and Abilities
Essential
- Substantial negotiations skills, able to demonstrate success across a wide range of disciplines and levels
- Working with high levels of accuracy and with attention to detail
- Ability to analyse and rationalize research information. Ability to make complex decisions
- Ability to work independently and proactively and as part of a team and to fit in with the demands of a busy, open-plan office.
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).
Employer details
Employer name
Great Ormond Street Hospital for Children NHS Foundation Trust
Address
UCL Institute of Child Health
30 Guilford Street
London
WC1N 1EH
Employer's website
https://www.gosh.nhs.uk/ (Opens in a new tab)
