Job summary
The Clatterbridge Cancer is the largest networked cancer centre serving a population of 2.4 million across Merseyside and Cheshire. The Trust has embedded research as part of a key aspect of patient choice. The Research and Innovation Team have established key work areas to set-up and deliver research studies for all patients. R&I has a Team work ethic and embodies the Trust values of Kindness, Empowered, Responsible and Inclusive. We are seeking a proactive, individual with a strong attitude of team working. This is an exciting opportunity for a motivated individual to join a dynamic team with research for patient at the heart of what we do.
Main duties of the job
The post-holder will have a key role in promoting the Trust's early phase research portfolio. They would develop and maintain good working relationships with pharmaceutical and biotechnology industry personnel and have primary responsibility for the Research Management and Governance (RM&G) arrangements for CCC early phase research projects. The post holder will oversee all aspects of early phase study set-up end to end from site selection to trial opening at site. They will provide effective support to the cancer multi-disciplinary team involved in the recruitment and management of patients on early phase clinical trials. The post-holder will be required to work closely with the ECMC, BRC and CRF Teams, Trust Consultants, NHS Managers, nursing and medical staff and other key research personnel from within the Trust and from the wider research environment
About us
The Clatterbridge Cancer Centre has a large research portfolio ranging from First in Human Trials to translational, real world and qualitative studies. There is an exciting opportunity for an Early Phase Trial Facilitator to join the Research Management and Governance Team. CCC has ECMC, BRC and CRF status that focusses on the early phase trials portfolio. This is a key area of research excellence for the Trust regionally and nationally. The post-holder will join a dedicated and driven team to provide fast set-up of early phase trials, contributing strongly to CCC's reputation for success in this area.
Job description
Job responsibilities
Work autonomously and provide specialist knowledge regarding the set-up and permissions process at CCC of early phase research.
- Act as first point of contact for research organisations wishing to engage with the Trust to support the early phase trials.
- Ensure local implementation of national research permissions systems for timely set-up of commercial research where CCC is a participating site.
- Ensure that the clinical trials are set-up in a timely manner and in line with Trust processes and legislation.
- Work with the Trusts Research Governance and Sponsorship Manager to report on study set-up activity through R&I, wider Trust and external organisations.
- Ensure that the impact of early phase research on service departments is identified.
- Work closely with the Trust service departments (and where necessary with service departments within our partner Trusts) to ensure all information required is captured.
- Work closely with Research Ethics Committees, Trust R&D Departments and commercial companies to ensure timely approval for early phase studies.
- Identify bottle-necks and work with respective organisations to streamline processes as required.
- Work closely with the members of Trust service departments who support trials to assure streamlined study set-up and permissions are in place. Co-ordinate costings for early phase trials where appropriate and work closely with the Finance Team to assure all activity is captured.
- Work closely with the Research Governance Manager and Team to assure timely implementation of amendments to the study both during the study set-up process and where there is a contract/ cost amendment in an established open study.
- Maintain effective communications to foster good working relationships with internal and external contacts.
- Provide and receive complex information and facilitate communication between different clinical services.
- Act as a point of contact for internal personnel and external organisations, resolving most queries independently or facilitating response from the most appropriate members of staff.
- To produce timely and accurate reports from the CCC Edge database on set-up and progress of early phase trials including recruitment activity and cohorts
- Participate in Site Initiation visits and assist in completing any outstanding actions to take study forward to site opening.
- Assure a seamless transition from declaration of C&C to Sponsor Greenlight.
- Site file Management oversight to assure that the files are maintained and up to date pre and post-SIV.
- Maintain accurate records and prepare for audits and inspections
- To provide advice and support on process to the wider Research and Innovation Team.
- To work with the Research Management and Governance Team for seamless integration of process.
- Provide updates on study status at R&I meetings including the Early Phase Trials Operational meetings
Work in close collaboration with the Research Partnerships Manager, the Head of Research Goverance and Sponsorship and the Head of Research Delivery to assure set-up of clinical trials at CCC.
Liaise with personnel across the R&I Directorate and other CCC Departments:
- Consultants involved in research projects.
- Research facing staff across the Trust
- Clinical Research Associates/ representatives from commercial companies and academic institutions.
- Link in with CCC ECMC, CRF and BRC Teams
- Research Practitioners.
- Data Co-ordinators.
- RM&G staff across other Trusts.
- Link and liaise with staff across the North West Coast Clinical Research Network.
Job description
Job responsibilities
Work autonomously and provide specialist knowledge regarding the set-up and permissions process at CCC of early phase research.
- Act as first point of contact for research organisations wishing to engage with the Trust to support the early phase trials.
- Ensure local implementation of national research permissions systems for timely set-up of commercial research where CCC is a participating site.
- Ensure that the clinical trials are set-up in a timely manner and in line with Trust processes and legislation.
- Work with the Trusts Research Governance and Sponsorship Manager to report on study set-up activity through R&I, wider Trust and external organisations.
- Ensure that the impact of early phase research on service departments is identified.
- Work closely with the Trust service departments (and where necessary with service departments within our partner Trusts) to ensure all information required is captured.
- Work closely with Research Ethics Committees, Trust R&D Departments and commercial companies to ensure timely approval for early phase studies.
- Identify bottle-necks and work with respective organisations to streamline processes as required.
- Work closely with the members of Trust service departments who support trials to assure streamlined study set-up and permissions are in place. Co-ordinate costings for early phase trials where appropriate and work closely with the Finance Team to assure all activity is captured.
- Work closely with the Research Governance Manager and Team to assure timely implementation of amendments to the study both during the study set-up process and where there is a contract/ cost amendment in an established open study.
- Maintain effective communications to foster good working relationships with internal and external contacts.
- Provide and receive complex information and facilitate communication between different clinical services.
- Act as a point of contact for internal personnel and external organisations, resolving most queries independently or facilitating response from the most appropriate members of staff.
- To produce timely and accurate reports from the CCC Edge database on set-up and progress of early phase trials including recruitment activity and cohorts
- Participate in Site Initiation visits and assist in completing any outstanding actions to take study forward to site opening.
- Assure a seamless transition from declaration of C&C to Sponsor Greenlight.
- Site file Management oversight to assure that the files are maintained and up to date pre and post-SIV.
- Maintain accurate records and prepare for audits and inspections
- To provide advice and support on process to the wider Research and Innovation Team.
- To work with the Research Management and Governance Team for seamless integration of process.
- Provide updates on study status at R&I meetings including the Early Phase Trials Operational meetings
Work in close collaboration with the Research Partnerships Manager, the Head of Research Goverance and Sponsorship and the Head of Research Delivery to assure set-up of clinical trials at CCC.
Liaise with personnel across the R&I Directorate and other CCC Departments:
- Consultants involved in research projects.
- Research facing staff across the Trust
- Clinical Research Associates/ representatives from commercial companies and academic institutions.
- Link in with CCC ECMC, CRF and BRC Teams
- Research Practitioners.
- Data Co-ordinators.
- RM&G staff across other Trusts.
- Link and liaise with staff across the North West Coast Clinical Research Network.
Person Specification
Education
Essential
- Educated to degree level (or equivalent) in relevant subject(s)
Desirable
- Training in ICH Good Clinical Practice Requirements
Knowledge and Expertise
Essential
- Experience of working within the NHS, pharmaceutical industry, or academic institution
- Knowledge of clinical trials processes
Desirable
Experience
Essential
- Experience of the UK ethical approval process
- Experience of trial set-up and regulatory framework
- Experience of facilitating meetings
Desirable
Person Specification
Education
Essential
- Educated to degree level (or equivalent) in relevant subject(s)
Desirable
- Training in ICH Good Clinical Practice Requirements
Knowledge and Expertise
Essential
- Experience of working within the NHS, pharmaceutical industry, or academic institution
- Knowledge of clinical trials processes
Desirable
Experience
Essential
- Experience of the UK ethical approval process
- Experience of trial set-up and regulatory framework
- Experience of facilitating meetings
Desirable
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).
