Job summary
The post holder will act as they key co-ordinator for assigned clinical trials administration teams to proactively ensure the provision of a comprehensive, high quality and efficient data management service. They will be involved in work allocation and monitoring across these teams, as well as their own workload comprising of data entry and query resolution as appropriate to the needs of their assigned teams. They will also be responsible for providing line management support activities for administrative team members as required by the post holder's line manager.
The post holder will support the work of the clinical research teams to ensure compliance with Trust Policy, Good Clinical Practice (GCP), standard operating procedures, research governance framework and all other relevant requirements.
Main duties of the job
The post holder will assist with the data management and administration of clinical trials from feasibility to archiving including (but not limited to):
- Facilitate the efficient and timely set up of clinical trials by creating trial workbooks for source data collection and ensuring these are ready for implementation.
- Manage own workload for daily trial activity including case report form (CRF) completion and query resolution to meet internal and external deadlines, whilst supporting and overseeing the workload of direct line reports.
- Support junior members of staff to work effectively to deadlines, manage a competing workload and prioritise effectively.
- Ensure quality assurance of all trial related documentation in accordance with relevant legislation and guidelines.
- Preparation for audit and inspections within assigned teams and implementation of action plans.
- Assist with the induction and training of new members of the research team.
- Contribute to the wider divisional and organisational needs of the Trust as appropriate.
- The post holder will be expected to be flexible to respond to change and organisational need.
About us
The Christie is one of Europe's leading cancer centres, treating over 60,000 patients a year. We are based in Manchester and serve a population of 3.2 million across Greater Manchester & Cheshire, but as a national specialist around 15% patients are referred to us from other parts of the country. We provide radiotherapy through one of the largest radiotherapy departments in the world; chemotherapy on site and through 14 other hospitals; highly specialist surgery for complex and rare cancer; and a wide range of support and diagnostic services. We are also an international leader in research, with world first breakthroughs for over 100 years. We run one of the largest early clinical trial units in Europe with over 300 trials every year. Cancer research in Manchester, most of which is undertaken on the Christie site, has been officially ranked the best in the UK.
Job description
Job responsibilities
DUTIES AND RESPONSIBILITIES TEAM SUPPORT
- Responsible for supporting and supervising workload allocation/monitoring across administrative team members, escalating issues to appropriate senior managers.
- Provide support to senior managers with general Human Resource activities, including but not limited to recruitment and selection and line management of administrative team members as required. This will be in accordance with Trust policies.
- Provide induction support and training to new and existing clinical trials staff through one-to-one and group learning
- Develop and maintain training and induction materials for the data management team.
- Encourage the sharing of best practice and dissemination of information through regular structured meetings with all trials administration
- Assist with data collection for data entry metrics and query resolution metrics for the clinical research
DATA MANAGEMENT
- Act as a point of contact for the core Research and Development team, study sponsors, clinical research organisations and specific research teams, communicating directly with them regarding data entry and queries, monitoring visits and other enquiries relevant to general trial conduct.
- Ensure the timely set up and initiation of source data workbooks for review by the lead Research Nurse and ensure version control is appropriately maintained.
- Track all payments throughout each clinical trial including completion of activity logs ensuring that all research activity is recorded to facilitate full cost
- Perform audits and spot checks on costings spreadsheets to ensure quality of income
- Assist with the maintenance of the investigator site files and essential documentation (filing consent forms and enrolment forms and completing patient logs) in accordance with ICH-GCP and Trust SOPs to ensure they are kept inspection ready at all
- Responsible for keeping trial folders, including blood results and laboratory requisition forms up to date in accordance with the studys standard operating procedure.
- Ensuring team reporting mechanisms are kept up to date (i.e. recruitment activity logs, patient visit logs, costings spreadsheets, CRF trackers, electronic proformas, serious adverse events trackers, data entry metrics trackers and workbook trackers).
- Ensure collection and tracking of clinical case notes for all patients, so that these are available as needed, for monitoring and audit
- Ensure that data collected for all trials meets protocol requirements and is complete and accurate and monitor this if
- To check the validity and completeness of research data collected within the Trust and take action to obtain or correct missing or contradictory
- Oversee and complete case report forms as per sponsor requirements to meet data entry deadlines stipulated in the clinical trial protocol and/or
- To resolve queries by initiating correspondence or direct contact with the research nurses/clinicians and other relevant health care professionals ensuring that reporting timelines are
- Provide information for senior managers including (but not limited to) case report from completion timeliness, data locks, data backlogs and workload
- Support the clinical research nurses to ensure that reports of serious adverse events are returned to co-ordinating centres/sponsors within the standard time frame.
- Resolve or escalate any concerns relating to protocol adherence, data quality, handling of confidential data or meeting
- Completion of clinical trial specific databases with data from various sources such as questionnaires, hospital records and other electronic and paper
- Liaise with internal and external NHS staff regarding case notes, data collection, archival tumour blocks, mortality data, and other general trial activities, which may be confidential and sensitive in
- To ensure confidentiality and security of patients data at all times, particularly when transferring data outside of the
- Arrange shipping and delivery of relevant trial data and documents including import/export of anonymised ECGs and copy
- Arrange team and trial related meetings as required, producing minutes in a timely
- Ensure that data is available and up to date for any meetings related to a clinicaltrial.
- If required attend project related meetings, investigator meetings (abroad or teleconferences, as necessary) and Site Initiation Visits to convey the relevant information to the study
- Prepare for audits and inspections within assigned
- Ensure that all documents including patient workbooks, blood results and other trial related documents are archived in the appropriate way by following the Trusts archiving
Undertake general administrative tasks as delegated by managerial representatives from the Research Division ton contribute to the smooth running of the patient recruitment teams.
Job description
Job responsibilities
DUTIES AND RESPONSIBILITIES TEAM SUPPORT
- Responsible for supporting and supervising workload allocation/monitoring across administrative team members, escalating issues to appropriate senior managers.
- Provide support to senior managers with general Human Resource activities, including but not limited to recruitment and selection and line management of administrative team members as required. This will be in accordance with Trust policies.
- Provide induction support and training to new and existing clinical trials staff through one-to-one and group learning
- Develop and maintain training and induction materials for the data management team.
- Encourage the sharing of best practice and dissemination of information through regular structured meetings with all trials administration
- Assist with data collection for data entry metrics and query resolution metrics for the clinical research
DATA MANAGEMENT
- Act as a point of contact for the core Research and Development team, study sponsors, clinical research organisations and specific research teams, communicating directly with them regarding data entry and queries, monitoring visits and other enquiries relevant to general trial conduct.
- Ensure the timely set up and initiation of source data workbooks for review by the lead Research Nurse and ensure version control is appropriately maintained.
- Track all payments throughout each clinical trial including completion of activity logs ensuring that all research activity is recorded to facilitate full cost
- Perform audits and spot checks on costings spreadsheets to ensure quality of income
- Assist with the maintenance of the investigator site files and essential documentation (filing consent forms and enrolment forms and completing patient logs) in accordance with ICH-GCP and Trust SOPs to ensure they are kept inspection ready at all
- Responsible for keeping trial folders, including blood results and laboratory requisition forms up to date in accordance with the studys standard operating procedure.
- Ensuring team reporting mechanisms are kept up to date (i.e. recruitment activity logs, patient visit logs, costings spreadsheets, CRF trackers, electronic proformas, serious adverse events trackers, data entry metrics trackers and workbook trackers).
- Ensure collection and tracking of clinical case notes for all patients, so that these are available as needed, for monitoring and audit
- Ensure that data collected for all trials meets protocol requirements and is complete and accurate and monitor this if
- To check the validity and completeness of research data collected within the Trust and take action to obtain or correct missing or contradictory
- Oversee and complete case report forms as per sponsor requirements to meet data entry deadlines stipulated in the clinical trial protocol and/or
- To resolve queries by initiating correspondence or direct contact with the research nurses/clinicians and other relevant health care professionals ensuring that reporting timelines are
- Provide information for senior managers including (but not limited to) case report from completion timeliness, data locks, data backlogs and workload
- Support the clinical research nurses to ensure that reports of serious adverse events are returned to co-ordinating centres/sponsors within the standard time frame.
- Resolve or escalate any concerns relating to protocol adherence, data quality, handling of confidential data or meeting
- Completion of clinical trial specific databases with data from various sources such as questionnaires, hospital records and other electronic and paper
- Liaise with internal and external NHS staff regarding case notes, data collection, archival tumour blocks, mortality data, and other general trial activities, which may be confidential and sensitive in
- To ensure confidentiality and security of patients data at all times, particularly when transferring data outside of the
- Arrange shipping and delivery of relevant trial data and documents including import/export of anonymised ECGs and copy
- Arrange team and trial related meetings as required, producing minutes in a timely
- Ensure that data is available and up to date for any meetings related to a clinicaltrial.
- If required attend project related meetings, investigator meetings (abroad or teleconferences, as necessary) and Site Initiation Visits to convey the relevant information to the study
- Prepare for audits and inspections within assigned
- Ensure that all documents including patient workbooks, blood results and other trial related documents are archived in the appropriate way by following the Trusts archiving
Undertake general administrative tasks as delegated by managerial representatives from the Research Division ton contribute to the smooth running of the patient recruitment teams.
Person Specification
Qualifications
Essential
- Degree in a science or health related discipline
- Relevant experience in scientific and medical research.
Desirable
- Post graduate certificate in clinical research or other relevant post graduate qualification.
Experience
Essential
- Significant experience in clinical trial administration or clinical trial data management.
- Experience of mentoring junior staff members or colleagues.
Desirable
- Previous experience of working within the NHS or other healthcare system.
- Direct line management experience.
- Experience in the use of iMedidata RAVE, InForm, RDC Onsite or other electronic case report forms.
Skills
Essential
- Ability to prioritise own and others workload and practice effective time management.
- Excellent interpersonal skills.
- Tactful and diplomatic.
- Excellent oral and written communication skills.
- Good IT skills including proficiency in the Microsoft Office suite.
- Attention to detail.
- Conscientious and hardworking
Desirable
- Advanced use of spreadsheets.
- Strong understanding of case report form design.
- Evidence of achievement under pressure.
Knowledge
Essential
- Good understanding of the clinical research delivery processes, related standards, governance and legislation.
Desirable
- Understanding of medical terminology and cancer.
- Knowledge of patient information systems.
Values
Essential
- Ability to demonstrate the organisational values and behaviours of The Christie NHS Foundation Trust.
Other
Essential
- Ability to work to tight and/or unexpected deadlines.
- Ability to work unsupervised or as part of a team.
Person Specification
Qualifications
Essential
- Degree in a science or health related discipline
- Relevant experience in scientific and medical research.
Desirable
- Post graduate certificate in clinical research or other relevant post graduate qualification.
Experience
Essential
- Significant experience in clinical trial administration or clinical trial data management.
- Experience of mentoring junior staff members or colleagues.
Desirable
- Previous experience of working within the NHS or other healthcare system.
- Direct line management experience.
- Experience in the use of iMedidata RAVE, InForm, RDC Onsite or other electronic case report forms.
Skills
Essential
- Ability to prioritise own and others workload and practice effective time management.
- Excellent interpersonal skills.
- Tactful and diplomatic.
- Excellent oral and written communication skills.
- Good IT skills including proficiency in the Microsoft Office suite.
- Attention to detail.
- Conscientious and hardworking
Desirable
- Advanced use of spreadsheets.
- Strong understanding of case report form design.
- Evidence of achievement under pressure.
Knowledge
Essential
- Good understanding of the clinical research delivery processes, related standards, governance and legislation.
Desirable
- Understanding of medical terminology and cancer.
- Knowledge of patient information systems.
Values
Essential
- Ability to demonstrate the organisational values and behaviours of The Christie NHS Foundation Trust.
Other
Essential
- Ability to work to tight and/or unexpected deadlines.
- Ability to work unsupervised or as part of a team.
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).
