Job summary
The LUHFT Clinical Research Unit (CRU) is a Phase 1 accredited unit, the first NHS trust in England and Wales to achieve this standard. The unit undertakes and delivers clinical trials in patients and healthy volunteers with a particular emphasis on early phase research.
The post holder will be responsible for the co-ordination of source data, CRFs and eCRFs, data entry, reporting and query resolution of data associated with clinical trials conducted on the CRU.
Main duties of the job
The post holder will be responsible for the co-ordination of source data, CRFs and eCRFs, data entry, reporting and query resolution of data associated with clinical trials conducted on the CRU.
They will assist Clinical Staff and Sponsors with the set-up of data requirements, CRF and electronic CRFs for clinical trials conducted on the CRU. They will enter data from paper source into electronic databases within agreed turnaround times and key milestone dates.
Perform timely quality control of CRFs and data entered into eCRFs as appropriate as well as other data as required. They will respond to any monitoring queries in relation to data in a timely manner and be the main point of contact for resolving data queries independently or referring on to the most appropriate member of staff. They will assist the Clinical Teams with any administration duties including transcribing data, scanning, photocopying etc.
Prioritise own workload and demonstrate a continuous process of professional and personal development and maintain a high level of knowledge concerning clinical research. To ensure that all clinical research activity is ICH GCP compliant and conducted in accordance with the agreed protocols.
The successful candidate will be a self-motivated person and must demonstrate evidence of continuing professional development.
About us
Liverpool University Hospitals NHS Foundation Trust was created on 1 October 2019 following the merger of two adult acute Trusts, Aintree University Hospital NHS Foundation Trust and the Royal Liverpool and Broadgreen University Hospitals NHS Trust.
The merger provides an opportunity to reconfigure services in a way that provides the best healthcare services to the city and improves the quality of care and health outcomes that patients experience.
The Trust runs Aintree University Hospital, Broadgreen Hospital, Liverpool University Dental Hospital and the Royal Liverpool University Hospital.
It serves a core population of around 630,000 people across Merseyside as well as providing a range of highly specialist services to a catchment area of more than two million people in the North West region and beyond.
To hear more about our achievements click herehttps://www.liverpoolft.nhs.uk/media/13089/1606-annual-report-booklet_final.pdf
Follow us on Social Media:
Facebook - Liverpool University Hospitals Careers
Instagram - @LUHFTcareers
Twitter - @LUHFTcareers
Job description
Job responsibilities
Assist Clinical Staff and Sponsors with the set-up of data requirements (source, CRF and electronic CRFs) for clinical trials conducted on the CRU
In conjunction with the CRU Project Manager, maintain a schedule of key data milestones for each study assigned to them in order to meet or exceed deadlines
Gain a thorough understanding of study specific CRF completion guidelines (where appropriate) for each study to ensure compliance with study specific instructions
In conjunction with the CRU Project Manager ensure any workbooks or source data capture documents are fit for purpose with respect to capturing data required in the protocol, eCRF and vice versa
Enter data from paper source into electronic databases within agreed turnaround times and key milestone dates
Perform timely quality control of CRFs and data entered into eCRFs as appropriate as well as other data as required
In conjunction with the Clinical staff ensure that data is made available to study monitors for monitoring visits
Respond to any monitoring queries in relation to data in a timely manner
Be the main point of contact for resolving data queries independently or referring on to the most appropriate member of staff
Ensuring that data queries are responded to in timely manner to ensure that key data milestones can be met or exceeded
Assist the Clinical Teams with any administration duties including transcribing data, scanning, photocopying etc.
Archive CRFs and other source data on completion of a study
Prioritise own workload to ensure that key data milestones and agreed Sponsor turnaround times are met or exceeded
Demonstrate a continuous process of professional and personal development and maintain a high level of knowledge concerning clinical research
To ensure that all clinical research activity is ICH GCP compliant and conducted in accordance with the agreed protocols
Provide training and support for the Clinical Team in relation to clinical trials database requirements
To have computer skills for the handling and management of computerised data
Job description
Job responsibilities
Assist Clinical Staff and Sponsors with the set-up of data requirements (source, CRF and electronic CRFs) for clinical trials conducted on the CRU
In conjunction with the CRU Project Manager, maintain a schedule of key data milestones for each study assigned to them in order to meet or exceed deadlines
Gain a thorough understanding of study specific CRF completion guidelines (where appropriate) for each study to ensure compliance with study specific instructions
In conjunction with the CRU Project Manager ensure any workbooks or source data capture documents are fit for purpose with respect to capturing data required in the protocol, eCRF and vice versa
Enter data from paper source into electronic databases within agreed turnaround times and key milestone dates
Perform timely quality control of CRFs and data entered into eCRFs as appropriate as well as other data as required
In conjunction with the Clinical staff ensure that data is made available to study monitors for monitoring visits
Respond to any monitoring queries in relation to data in a timely manner
Be the main point of contact for resolving data queries independently or referring on to the most appropriate member of staff
Ensuring that data queries are responded to in timely manner to ensure that key data milestones can be met or exceeded
Assist the Clinical Teams with any administration duties including transcribing data, scanning, photocopying etc.
Archive CRFs and other source data on completion of a study
Prioritise own workload to ensure that key data milestones and agreed Sponsor turnaround times are met or exceeded
Demonstrate a continuous process of professional and personal development and maintain a high level of knowledge concerning clinical research
To ensure that all clinical research activity is ICH GCP compliant and conducted in accordance with the agreed protocols
Provide training and support for the Clinical Team in relation to clinical trials database requirements
To have computer skills for the handling and management of computerised data
Person Specification
Qualifications
Essential
- Good Standard of education to a minimum A level or equivalent including science
Desirable
Experience
Essential
- Demonstrable previous experience in clinical research studies, research projects (protocols and study documentation)
- Skills in the collection, analysis and interpretation of data especially in relation to eCRFs
Knowledge
Essential
- Knowledge of the principles & practice of clinical research and/or clinical trials
- An understanding of ethical and quality standard applicable to clinical trials, including EU directive on ICH GCP requirements
Desirable
- An understanding of the independent monitoring process of clinical trials
Skills
Essential
- Meticulous attention to detail and a high standard of accuracy, e.g. in the capture and validation of clinical trial data
- Excellent interpersonal and communication skill both written and verbal
- Ability to work to tight deadlines and prioritise own workload
- Skills in handling and management of computerised data (e.g. the abstraction and coding of medical data, computer data entry, report generation and data validation)
- Computer skills; Microsoft Word, Excel, Access, Internet, Email, Clinical Trials Databases
Other
Essential
- Flexible approach to working hours
Person Specification
Qualifications
Essential
- Good Standard of education to a minimum A level or equivalent including science
Desirable
Experience
Essential
- Demonstrable previous experience in clinical research studies, research projects (protocols and study documentation)
- Skills in the collection, analysis and interpretation of data especially in relation to eCRFs
Knowledge
Essential
- Knowledge of the principles & practice of clinical research and/or clinical trials
- An understanding of ethical and quality standard applicable to clinical trials, including EU directive on ICH GCP requirements
Desirable
- An understanding of the independent monitoring process of clinical trials
Skills
Essential
- Meticulous attention to detail and a high standard of accuracy, e.g. in the capture and validation of clinical trial data
- Excellent interpersonal and communication skill both written and verbal
- Ability to work to tight deadlines and prioritise own workload
- Skills in handling and management of computerised data (e.g. the abstraction and coding of medical data, computer data entry, report generation and data validation)
- Computer skills; Microsoft Word, Excel, Access, Internet, Email, Clinical Trials Databases
Other
Essential
- Flexible approach to working hours
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).
