Job summary
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
About us
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.
Job description
Job 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 Trusts 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 teams 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
Job description
Job 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 Trusts 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 teams 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
- Master's degree in life sciences or related field OR demonstrable equivalent theoretical knowledge /experience
- GCP certificate
- Evidence of continuous professional development
Desirable
- Teaching experience
- Project Management Qualification (eg PRINCE 2)
Previous experience
Essential
- 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
- Experience within oncology and haematology clinical services
- Demonstrable managerial /team lead experience
- Experience of financial management
Skills
Essential
- 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
- Ability to carry out Audits
Additional Information
Essential
- Flexible and positive approach to work
- Highly motivated and enthusiastic
Person Specification
Knowledge/Qualifications
Essential
- Master's degree in life sciences or related field OR demonstrable equivalent theoretical knowledge /experience
- GCP certificate
- Evidence of continuous professional development
Desirable
- Teaching experience
- Project Management Qualification (eg PRINCE 2)
Previous experience
Essential
- 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
- Experience within oncology and haematology clinical services
- Demonstrable managerial /team lead experience
- Experience of financial management
Skills
Essential
- 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
- Ability to carry out Audits
Additional Information
Essential
- Flexible and positive approach to work
- Highly motivated and enthusiastic
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).
