Job summary
University Hospitals Plymouth NHS Trust is looking for people with a keen interest in data to join our busy Research & Development Team based at Derriford Hospital.
Research has been at the forefront of the Covid-19 pandemic and as a consequence we are looking to expand our data management team. Your duties would involve data management and general administrative work to support the work of our busy clinical delivery team.
Looking for a new challenge, a career in research and to be part of a growing team then this could be the opportunity you are looking for. You will be fully supported with training from our experienced research team.
If you are interested and would like to know more about the role please contact the Data Manager Team Lead Kai Hajaree on 01752 432842 or k.hajaree@nhs.net
Main duties of the job
Main Duties of the Job
The post holder will work as part of the clinical research team to support the safe conduct of research in accordance with the Research Governance Framework and Good Clinical Practice guidelines and provide assurance that the rights, safety and well-being of trial participants are protected.
The post-holder will work with the research team to provide data management, administrative and clerical support for research study delivery across an extensive portfolio of clinical trials.
About us
We are a people business - where every member of staff matters and can make a difference. Patients are at the heart of everything we do. Joining University Hospitals Plymouth NHS Trust means becoming part of a team of dedicated staff, who are committed to leading the way through innovation, clinical excellence and great customer care. The Trust has great opportunities for career development in a highly progressive working environment. We offer all of this in a vibrant, modern city with a historic reputation for adventure.
We recognise that work life balance is important for our colleagues and so we welcome requests from applicants who are looking for less than full time/flexible working for our advertised roles. Please contact the recruiting manager to discuss this prior to your application submission. We commit to giving this full consideration in each case. We encourage people from diverse backgrounds to apply for our roles, as diversity strengthens our teams. It is sometimes necessary to close vacancies before the closing date. If you have not heard from us within 4 weeks of the closing date, please assume that you have not been shortlisted.
***Preference will be given to internal Trust staff, as well as 'Priority' and 'At Risk' status including NHS At Risk staff throughout Devon who are able to display recent relevant experience as dictated by the Person Specification.***
Job description
Job responsibilities
Detailed job description and main responsibilities
Assist the clinical research team in co-ordinating a portfolio of studies.
Participate in Good Clinical Practice (GCP) training and ensures GCP compliance of self and team.
With support, have an understanding of the study set up process including:
- Assist in completing Expression of interest / study selection documents
- Liaise with the study sponsor and research team to gather all relevant study information
- Prepare submissions for local research and development approval
- Coordinate site initiation meetings
- Set up the local site file and any relevant databases and documents for the study
Take a leading role in on-going study coordination including:
- Conduct regular site file maintenance to ensure study essential documents are version controlled and are maintained according to regulatory requirements
- Maintain effective communication between the study sponsor and the clinical research team
- Support local implementation of study amendments
- Update quality systems to record study information and enrolled patients details
- Coordinate study monitoring visits
- Support the research team with data queries and reporting as required
- Consistently demonstrate the ability to work accurately
- Conducting investigator site file checklists when required
Take a leading role in study close out procedures including:
- Liaise with the sponsor for final monitoring visit
- Liaise with R&D regarding study close out and archiving
- Assist with data management according to study complexity and ensure that data is transcribed accurately where required
- Support internal audit and monitoring
- Support appropriate studies within PHNT/UHP
Job description
Job responsibilities
Detailed job description and main responsibilities
Assist the clinical research team in co-ordinating a portfolio of studies.
Participate in Good Clinical Practice (GCP) training and ensures GCP compliance of self and team.
With support, have an understanding of the study set up process including:
- Assist in completing Expression of interest / study selection documents
- Liaise with the study sponsor and research team to gather all relevant study information
- Prepare submissions for local research and development approval
- Coordinate site initiation meetings
- Set up the local site file and any relevant databases and documents for the study
Take a leading role in on-going study coordination including:
- Conduct regular site file maintenance to ensure study essential documents are version controlled and are maintained according to regulatory requirements
- Maintain effective communication between the study sponsor and the clinical research team
- Support local implementation of study amendments
- Update quality systems to record study information and enrolled patients details
- Coordinate study monitoring visits
- Support the research team with data queries and reporting as required
- Consistently demonstrate the ability to work accurately
- Conducting investigator site file checklists when required
Take a leading role in study close out procedures including:
- Liaise with the sponsor for final monitoring visit
- Liaise with R&D regarding study close out and archiving
- Assist with data management according to study complexity and ensure that data is transcribed accurately where required
- Support internal audit and monitoring
- Support appropriate studies within PHNT/UHP
Person Specification
Qualifications
Essential
- GCSEs including English and Mathematics at grade A-C (or equivalent demonstrable experience)
- NVQ in Administration or equivalent demonstrable experience
Desirable
- Good Clinical Practice Training
Knowledge/Experience
Essential
- Excellent organisation skills
- Proven working knowledge of Microsoft office packages (spreadsheets, databases, word processing and e-mail)
- Demonstrable data management experience
- Previous employment within a healthcare setting
Desirable
- Understanding of the clinical research process including Good Clinical Practice
- Demonstrable clinical research experience
Person Specification
Qualifications
Essential
- GCSEs including English and Mathematics at grade A-C (or equivalent demonstrable experience)
- NVQ in Administration or equivalent demonstrable experience
Desirable
- Good Clinical Practice Training
Knowledge/Experience
Essential
- Excellent organisation skills
- Proven working knowledge of Microsoft office packages (spreadsheets, databases, word processing and e-mail)
- Demonstrable data management experience
- Previous employment within a healthcare setting
Desirable
- Understanding of the clinical research process including Good Clinical Practice
- Demonstrable clinical research experience
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).
