Job summary
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 a Research Governance Facilitator to join the Research Management and Governance Team. The post-holder will join a dedicated and driven team to provide essential research governance support on studies where CCC is a participating site and also for studies where CCC acts as SponsorThis is a unique and important role within the Research Management and Governance Team within R&I at the Clatterbridge Cancer Centre. The role includes the provision of critical business intelligence to the R&I Team on metrics and study progression. The post-holder will play a pivotal role in the seamless linkage between site qualification, set-up and greenlight to study opening; working between the Research Management and Governance Team and Research Delivery Team.
Main duties of the job
To manage the information in the CCC Edge database, producing timely, accurate and consistent information including performance reports on CCC research activity and audit of the database. The post-holder is expected to provide trend analysis and key Business Intelligence and analysis on all R&I research activity. The post-holder would develop and maintain databases to record SAEs, GCP Training Records, external visitors/ monitors' access, Research Passports and Letters of Access. Work to tight deadlines with minimal supervision. Provide trial facilitation services to provide a seamless link between the Research Management and Governance Team and the Delivery Team. This will include attendance and organisation of Site Qualification Visits, completion of local feasibility forms and linking capacity and capability completion with Site Initiation Visits and First Patient Recruited.
About us
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.
Job description
Job responsibilities
The post holder will assist with the following duties:
CCC Edge Database:
Administration, audit and staff training on the CCC Edge database.
- To produce performance reports on request, provide trending reports and assure that all data fields are inputted. The individual would be expected to review any external reports and assure the information concerning CCC is up to date and correct.
- To produce reports from Edge to submit to the Department of Health or equivalent as needed and ensure the data are complete and correctly uploaded.
- The post-holder would be expected to produce recruitment reports for the Head of Research Delivery as required and audit the Edge database to assure accuracy and quality of data.
- The individual would be expected to assure the information in the Edge database to track studies through the NHS Permission process is correct and up to date and to flag studies that are behind target.
- The post-holder is expected to produce reports for ECMC, BRC and CRF related research, for CCC-led research and for R&I meetings as required.
- The post-holder is expected to critically analyse the data and provide narrative on the reports.
- To assist in the production and submission of statuary reports.
- Present the data and narrative as required in Trust meetings.
- To assist in the development of information production and delivery systems and provide user support.
- Link in with Trust BI to ensure oversight of Trust R & I dashboards and information flow to Trust systems
- Support freedom of information requests
- Produce ad-hoc reports for executive team and and senior level meetings/reports.
- End to end set-up and Trial Delivery support: To provide seamless support in the set-up process from Site Qualification Visits to connecting capacity and capability sign off to Site Initiation Visits and study Greenlight.
- Feasibility: Facilitate the completion of CCC local feasibility forms as part of the CCC NHS Permission process, working with Research Practitioners and Principle Investigators to assure completion. Identify blockers and seek to work with relevant staff to address these issues. Work with the clinical team to seek a decision if a study is suitable to advance to set up.
- Document Management: To control the Research specific Standard Operating Procedures (SOPs) and Work Instructions, assuring version control and the monitoring of staff training on new SOPs, assuring controlled access to the SOPs and Work Instructions where appropriate.
- Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR) reporting: To set and maintain a database to record CCC SAEs; collation of the SAE reports from CCC to forward to the Clinical Governance Team.
- Good Clinical Practice (GCP): To oversee the maintenance of the database of the CCC GCP Training spreadsheet and CVs.
- Research Passports/ Letters of Access: To maintain and support review issuance of Letters Of Access, track those that have expired/ no longer required.
- R&D Website: To assist with the development and continuing periodic updating of the R&I section of the CCC Website.
- General trial facilitation/ administration in support of the Head of Research Governance and Sponsorship.
- Work with the Head of Research Delivery and the Delivery Team to assure smooth transition from Research Management and Governance Team to Delivery Team.
- To produce timely and accurate reports from the Edge database in line with internal and externally required reports.
- Use of analytical skills to interpret raw data and present the data in an appropriate format, e.g. tabular or graphical.
- Produce information on trending.
- Analysis of raw data to determine delivery to targets and KPIs.
- Provide training on all aspects of CCC Edge database use.
- The post-holder will be required to prioritise their own workload and deadlines, ensuring all reports are delivered on time.
- The post-holder will be responsible for assuring that the CCC Edge database is maintained and the data accurate.
- Facilitate end to end support from Site Qualification to Greenlight.
Work in close collaboration with the Head of Research Governance and Sponsorship and Head of Research Delivery.
- Liaise with personnel across the R&I Directorate and other CCC Departments:
- Consultants involved in research projects.
- Clinical Research Associates/ representatives from commercial companies.
- Research Practitioners.
- Research Officers
- Digital Team.
- Key collaborators including industry, CRN contacts and clinical trials units
Job description
Job responsibilities
The post holder will assist with the following duties:
CCC Edge Database:
Administration, audit and staff training on the CCC Edge database.
- To produce performance reports on request, provide trending reports and assure that all data fields are inputted. The individual would be expected to review any external reports and assure the information concerning CCC is up to date and correct.
- To produce reports from Edge to submit to the Department of Health or equivalent as needed and ensure the data are complete and correctly uploaded.
- The post-holder would be expected to produce recruitment reports for the Head of Research Delivery as required and audit the Edge database to assure accuracy and quality of data.
- The individual would be expected to assure the information in the Edge database to track studies through the NHS Permission process is correct and up to date and to flag studies that are behind target.
- The post-holder is expected to produce reports for ECMC, BRC and CRF related research, for CCC-led research and for R&I meetings as required.
- The post-holder is expected to critically analyse the data and provide narrative on the reports.
- To assist in the production and submission of statuary reports.
- Present the data and narrative as required in Trust meetings.
- To assist in the development of information production and delivery systems and provide user support.
- Link in with Trust BI to ensure oversight of Trust R & I dashboards and information flow to Trust systems
- Support freedom of information requests
- Produce ad-hoc reports for executive team and and senior level meetings/reports.
- End to end set-up and Trial Delivery support: To provide seamless support in the set-up process from Site Qualification Visits to connecting capacity and capability sign off to Site Initiation Visits and study Greenlight.
- Feasibility: Facilitate the completion of CCC local feasibility forms as part of the CCC NHS Permission process, working with Research Practitioners and Principle Investigators to assure completion. Identify blockers and seek to work with relevant staff to address these issues. Work with the clinical team to seek a decision if a study is suitable to advance to set up.
- Document Management: To control the Research specific Standard Operating Procedures (SOPs) and Work Instructions, assuring version control and the monitoring of staff training on new SOPs, assuring controlled access to the SOPs and Work Instructions where appropriate.
- Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR) reporting: To set and maintain a database to record CCC SAEs; collation of the SAE reports from CCC to forward to the Clinical Governance Team.
- Good Clinical Practice (GCP): To oversee the maintenance of the database of the CCC GCP Training spreadsheet and CVs.
- Research Passports/ Letters of Access: To maintain and support review issuance of Letters Of Access, track those that have expired/ no longer required.
- R&D Website: To assist with the development and continuing periodic updating of the R&I section of the CCC Website.
- General trial facilitation/ administration in support of the Head of Research Governance and Sponsorship.
- Work with the Head of Research Delivery and the Delivery Team to assure smooth transition from Research Management and Governance Team to Delivery Team.
- To produce timely and accurate reports from the Edge database in line with internal and externally required reports.
- Use of analytical skills to interpret raw data and present the data in an appropriate format, e.g. tabular or graphical.
- Produce information on trending.
- Analysis of raw data to determine delivery to targets and KPIs.
- Provide training on all aspects of CCC Edge database use.
- The post-holder will be required to prioritise their own workload and deadlines, ensuring all reports are delivered on time.
- The post-holder will be responsible for assuring that the CCC Edge database is maintained and the data accurate.
- Facilitate end to end support from Site Qualification to Greenlight.
Work in close collaboration with the Head of Research Governance and Sponsorship and Head of Research Delivery.
- Liaise with personnel across the R&I Directorate and other CCC Departments:
- Consultants involved in research projects.
- Clinical Research Associates/ representatives from commercial companies.
- Research Practitioners.
- Research Officers
- Digital Team.
- Key collaborators including industry, CRN contacts and clinical trials units
Person Specification
Education
Essential
- Degree in a related subject or equivalent experience
Desirable
- Business Intelligence qualification
Knowledge
Essential
- Ability to interrogate databases, extract and analyse information and provide narrative
- Provide end to end support on trial set-up to greenlight
Desirable
- Knowledge of patient information systems
- Knowledge of the processes and documentation required for gaining NHS permission for a research study to open
Experience
Essential
- Analysing large and complicated datasets
- Presentation of data in written and graphical format
Desirable
- Experience in extracting information from the NIHR / national databases
Person Specification
Education
Essential
- Degree in a related subject or equivalent experience
Desirable
- Business Intelligence qualification
Knowledge
Essential
- Ability to interrogate databases, extract and analyse information and provide narrative
- Provide end to end support on trial set-up to greenlight
Desirable
- Knowledge of patient information systems
- Knowledge of the processes and documentation required for gaining NHS permission for a research study to open
Experience
Essential
- Analysing large and complicated datasets
- Presentation of data in written and graphical format
Desirable
- Experience in extracting information from the NIHR / national databases
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).
