Clinical Trials Start Up Specialist

Guy's and St Thomas' is among the UK's busiest and most successful NHS foundation trusts. We provide a full range of hospital and community services for people in south London and as well as specialist care for patients from further afield including cancer, renal, orthopaedic, respiratory and cardiovascular services.

Guy's is home to the largest dental school in Europe and a £160 million Cancer Centre opened in 2016. As part of our commitment to provide care closer to home, in 2017 we also opened a cancer centre and a kidney treatment centre at Queen Mary's Hospital in Sidcup. St Thomas' has one of the largest critical care units in the UK and one of the busiest emergency departments in London. It is also home to Evelina London Children's Hospital.

Evelina London cares for local children in Lambeth and Southwark and provides specialist services across south east England including cardiac, renal and critical care services. We lead a number of specialist service networks aiming to ensure children are treated locally where possible, but have access to specialist expertise when they need it. Our community services include health visiting, school nursing and support for families of children with long-term conditions.

Our adult community services teams deliver care at the heart of the local communities we serve, working in partnership with GPs, local authorities and other healthcare and voluntary sector organisations. Working with our partners in Lambeth and Southwark, we are focusing on new ways of working to improve care for local patients.

In February 2021 the Royal Brompton and Harefield joined Guy's and St Thomas' NHS Foundation Trust, bringing together world-leading expertise in the care and research of heart and lung disease. Our merger provides a once in a generation opportunity to build a lasting, world-renowned heart and lung centre, providing the highest quality care for patients and conducting world-leading research.

We have a reputation for clinical excellence and high quality teaching and research. We are part of King's Health Partners, one of eight accredited UK academic health sciences centres. In partnership with King's College London we have dedicated clinical research facilities including an MHRA accredited Phase I clinical trials unit.

Patients are at the heart of everything we do and we pride ourselves on ensuring the best possible patient experience as well as safe, high quality care. We are proud to have one of the lowest mortality rates in the NHS. Following a comprehensive Care Quality Commission (CQC) inspection in 2019 we maintained our overall rating of 'good'. Our adult community services achieved a rating of 'outstanding'.

The commitment of our 23,500 staff is key to our success. We are one of the largest local employers and we aim to develop and support all our staff so they are able to deliver high quality, safe and efficient care. The 2019 NHS staff survey results show that we have one of the most engaged and motivated workforces in the NHS. We know this has a positive impact on the care provided to our patients.

We have one of the most ambitious capital investment programmes anywhere in the NHS.

Job overview

As a Clinical Trial Set-Up Specialist, you will play a crucial role in leading the initiation and set-up of commercial and non-commercial clinical trials within OHCT. You will be responsible for ensuring feasibility, reviewing clinical trial budgets, conducting financial negotiations with commercial and non-commercial sponsors and Contract Research Organisations (CROs), ensuring financial viability of trials. Your primary focus will be on driving the efficient and timely set-up of trials, collaborating closely with the King's Health Partners Clinical Trials Office (KHP-CTO), Guy's and St Thomas' R&D, support departments, research team and investigators to meet established timelines and targets. Alongside set-up, this post will oversee coordination of amendments for the department ensuring they are correctly tracked, processed and implemented within appropriate timeframes. This role will also oversee line management of the OHCT Imaging Coordinator and Roving Data Managers and delivering training on topics related to trial set-up.

Main duties of the job

• Work autonomously to manage the feasibility and set up of a large portfolio of commercial and non-commercial trials
• To have input into the feasibility process to ensure viability of new clinical trials being brought into the department including attendance and input at site selection visits, assistance with feasibility questionnaires as required and input into Trials Adoption Feasibility Forms (TAFFs).

• Review and develop, as necessary, systems to aid the negotiation of commercial contracts in relation to clinical departments such as pharmacy, pathology, radiology.
• To work closely with KHP-CTO and Trust R&D as required to ensure the timely set-up of commercial and non-commercial clinical trials.
• Co-ordinate submissions for Ethics Committee/R&D Committee/ Joint Clinical Trials Office approval for commercial and investigator-initiated trials and ensure that all the requirements of the Research Governance Framework are met for those trials.
• To identify bottlenecks, inefficiencies, and areas for improvement in trial initiation and management.
• To act as a resource for research staff concerning regulatory and approval matters.
• Communicate with a range of internal and external groups and individuals to provide advice, guidance and often interpretation of complex business information and data requirements

Working for our organisation

Guy's and St Thomas' NHS Foundation Trust comprises five of the UK's best known hospitals - Guy's, St Thomas', Evelina London Children's Hospital, Royal Brompton and Harefield - as well as community services in Lambeth and Southwark, all with a long history of high quality care, clinical excellence, research and innovation.

We have a long tradition of clinical and scientific achievement and - as part of King's Health Partners - we are one of England's eight academic health sciences centres, bringing together world-class clinical services, teaching and research. We have dedicated clinical research facilities.

As part of Kings Health Partners, the Oncology and Haematology Clinical Trials (OHCT) team is made up of seventy plus staff members consisting of Research Nurses, Clinical Trial Practitioners, Clinical Trial Coordinators, data managers and the Safety & Support Team at Guys' and St Thomas' NHS Foundation Trust.

We work closely with the oncology and haematology medical teams to recruit patients to our trials and to ensure patients are monitored closely throughout. We have a large portfolio of Phase II and III trials; which are split into teams for specific tumour groups. We also have a team dedicated to early phase trials and run weekly early phase clinics in the Clinical Research Facility. We attract commercial and non-commercial trials, ranging from interventional drug or radiotherapy trials to observational studies.

Detailed job description and main responsibilities

Trial Set-Up

• To have input into the feasibility process to ensure viability of new clinical trials being brought into the department including attendance and input at site selection visits, assistance with feasibility questionnaires as required and input into Trials Adoption Feasibility Forms (TAFFs).

• Review and develop, as necessary, systems to aid the negotiation of commercial contracts in relation to clinical departments such as pharmacy, pathology, radiology.
• To work closely with KHP-CTO and Trust R&D as required to ensure the timely set-up of commercial and non-commercial clinical trials.
• To conduct reviews of commercial clinical trial budgets ensuring financial viability from an OHCT perspective based on consideration of the trial protocol, discussions with investigators regarding resource implications, set-up fees and external department utilisation.
• To conduct reviews of non-commercial agreements and the Schedule of Events Cost Attribution Template (SoECAT), working with the Research Business Development and Initiation Manager to review funding.
• To work with Trust R&D to complete confirmation of capacity and capability assessments for the set-up of non-commercial clinical trials.
• To undertake financial negotiations with commercial companies, clinical research organisations and Trust Investigators as necessary.
• To build working relationships with key stakeholders to ensure smooth running of the trial set-up process.
• To identify and liaise with necessary support departments to confirm capacity to support OHCT trials and collect relevant costs and documentation as required for trial governance during set-up.
• To coordinate with support departments, research teams, investigators and Trust R&D/KHP-CTO to ensure trials are opened to pre-agreed time and target.
• To assist the Research Business Development and Initiation Manager with Investigator-Led clinical trial set-up and development of research agreements.

Management and Leadership

• Lead and support staff within the management support team acting as an expert resource, demonstrating tenacity, drive, professional integrity, balance and perspective.
• Motivate, develop, support and identify training needs for department staff and take a proactive role in the department training programme
• Implement and work within the Trust's HR policies on all staffing matters, including sickness, capability and disciplinary issues. Take corrective measures if indicated in liaison with Human Resources and the Management Team.
• Agree the team's study and annual leave requirements and provide cover when necessary for annual leave, study leave and sick leave.
• To contribute to yearly business planning in conjunction with the service management team.
• Act as a role model for excellence in research delivery
• To line manage and coordinate the workload of the OHCT Imaging Coordinator
• To line manage team of data managers and work with relevant team leads regarding their allocation.
• To provide support and guidance to team members on all aspects of commercial and non-commercial clinical trial set-up.
• To lead clinical trial set-up training and model practices to OHCT staff members and external team members (where required).

Research Management
• Co-ordinate submissions for Ethics Committee/R&D Committee/ Joint Clinical Trials Office approval for commercial and investigator-initiated trials and ensure that all the requirements of the Research Governance Framework are met for those trials.

• To identify bottlenecks, inefficiencies, and areas for improvement in trial initiation and management.
• To oversee, track and ensure timely processing and implementation of amendments for the department.
• To act as a resource for research staff concerning regulatory and approval matters.
• To attend and contribute to relevant research team monthly meetings, OHCT Adoption and Feasibility Committee meetings and Sponsor meetings (where required).
• To lead on primary and secondary research, audits and evaluations as required.
• To assist the Research Business Development and Initiation Manager with projects as required
• To lead on the collation of data, including accrual, generated from clinical trials.
• Build strong professional relationships with other departments in order to promote a good working environment.

Communication and Information Management

• Communicate with a range of internal and external groups and individuals to provide advice, guidance and often interpretation of complex business information and data requirements
• Use persuasion and negotiation to secure information in line with competing deadlines
• Attend a range of meetings with senior staff to present data or information gathered, take questions or find further information to strengthen business cases
• Provide first point of contact for a range of business initiatives
• Promote the work of the research team and disseminate publications and information material
• Assist with the set up and implementation of appropriate IT systems in support of the research processes and trials, in conjunction with local Trust IT departments and the research sponsors

Professional Development

• Attend the training programmes and other relevant education and training days as agreed in your development plan.
• Take personal responsibility for own professional growth and keep up to date with professional development and research.
• Undertake performance review at regular intervals.
• Ensure adherence to trust policies throughout the team

Person specification

Knowledge/Qualifications

Essential criteria

• Master's degree in life sciences or related field OR demonstrable equivalent theoretical knowledge /experience
• GCP certificate
• Evidence of continuous professional development

Desirable criteria

• Teaching experience
• Project Management Qualification (eg PRINCE 2)

Previous experience

Essential criteria

• Significant experience in clinical research coordination including managing own portfolio of studies.
• Experience of running of clinical trials (including budget negotiations and liaison with outside departments)
• Knowledge and experience of handling complex relationships
• Experience mentoring, developing and supervising junior staff
• Experience teaching, assessing, supervising others
• Experience managing complex projects

Desirable criteria

• Experience within oncology and haematology clinical services
• Demonstrable managerial /team lead experience
• Experience of financial management

Skills

Essential criteria

• Evidence of excellent communication and interpersonal skills to develop and maintain effective relationships with a variety of staff/external bodies.
• Able to provide highly specialist advice to all relevant stakeholders
• Awareness of changing trends within research and clinical trials
• Up to date knowledge relevant to clinical research and good clinical practice
• Ability to set direction and prioritise with a willingness to accept responsibility workload/meet/set deadlines
• Use analytical and judgement skills including understanding and application of complex statistical and numerical data.
• Ability to lead, teach, supervise and mentor others in relation to all aspects of clinical research delivery
• Confident and articulate, able to negotiate in complex situations
• Presentation skills

Desirable criteria

• Ability to carry out Audits

Additional Information

Essential criteria

• Flexible and positive approach to work
• Highly motivated and enthusiastic

Guy's and St Thomas' celebrates, respects and values the diversity of its staff and patients. We review our policies, procedures and practices to ensure that all employees, patients and carers are treated equitable according to their needs. We are actively committed to ensuring that no one who applies for a job, works or study's at the Trust, or accesses our services is discriminated against on the grounds of race, ethnicity, nationality, disability, religion or belief, age, gender identity , gender reassignment, sexual orientation, pregnancy and maternity/paternity, or marital/civil partnership.

Applications are welcomed from applicants with a disability. We can make reasonable adjustments and offer support and advice in a variety of ways throughout the application process. Equality of opportunity is our policy.

As an organisation we are committed to developing our services in ways that best suit the needs of our patients. This means that some staff groups will increasingly be asked to work a more flexible shift pattern so that we can offer services in the evenings or at weekends.

Flexible working

We are committed to supporting all employees to achieve a healthy work life balance and to work in a way that is best for them and our patients. We will consider all requests to work flexibly, taking in to account the individual's personal circumstances as well the needs of the service. We encourage all prospective applicants to discuss their individual circumstances with the recruiting manager as part of the on-boarding process.

Due to recent changes in the UK immigration rules which affect Skilled Worker Visas, Global Business Mobility, Higher Skill Level and Increased Salary Thresholds, please ensure that you are able to meet the requirements to live and work in the UK before applying. Further information about eligibility is available on the UK Government website.

Your e-mail address is important to us - We communicate to all job applicants via the e-mail address which has been provided on the application form. Please ensure that you check your e-mail on a regular basis.

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Employer certification / accreditation badges

Applicant requirements

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.

Documents to download

• SUS JD/PS (PDF, 272.4KB)
• FRF (PDF, 368.6KB)