Job summary
Closing Date: 25th June 2025(this may change dependent on response)
Shortlisting to take place in the week following closing date: commencing 30th June 2025 (this may change dependent on response)
Interview expected to take place in the week following shortlisting: commencing 7th July 2025 (this may change dependent on response)
As one of 15 NIHR-funded Commercial Research Delivery Centres (CRDCs) across England, the CRDC - Bradford & West Yorkshire is part of a national initiative to enhance the NHS's capacity to deliver high-quality, late-phase commercial research. The Centre provides rapid study set-up, streamlined contracting and delivery processes, and dedicated research staff and facilities. This collaborative approach supports significant growth in commercial research, offering more patients the opportunity to access cutting-edge treatments earlier.
The Start-Up Administrator will play a central role in the efficient and compliant initiation of commercial clinical trials within the NIHR Bradford & West Yorkshire CRDC. Working closely with the Study Coordinator, Principal Investigators, Research Nurses, R&D, and sponsor representatives, the postholder will work on the administrative set-up of clinical trials from expression of interest through to study activation.
Main duties of the job
They will act as a key liaison for internal and external stakeholders involved in trial start-up, ensuring that all regulatory, contractual, training, and documentation requirements are met in line with sponsor timelines and NIHR best practices. This includes scheduling key meetings (e.g., Site Qualification and Site Initiation Visits), maintaining accurate documentation (e.g., training logs, CVs, ISF/Pharmacy files), and supporting preparation for greenlight approval.
In addition to trial start-up activities, the postholder will:
- Support the wider CRDC portfolio by circulating amendment documentation, tracking progress using systems such as EDGE and Kanbanchi, and facilitating effective cross-departmental communication.
- Coordinate site-specific meetings with research nurses and relevant support services (e.g., pharmacy, radiology).
- Ensure information is clearly disseminated to teams and that all staff are adequately trained and prepared for study delivery.
- Maintain oversight of SOP compliance and contribute to process improvement by providing feedback and identifying bottlenecks.
This role does not involve direct patient care, but rather ensures trials are set up for successful delivery by enabling streamlined, well-documented processes that meet sponsor and regulatory standards.
About us
Our People Charter outlines the behaviours we can expect from one another and what you can expect from Bradford Teaching Hospitals Foundation Trust:
- We value people
- We are one team
- We care
We're keen to meet people who share these values and are passionate about delivering the highest quality of care to our patients.
Job description
Job responsibilities
They will act as a key liaison for internal and external stakeholders involved in trial start-up, ensuring that all regulatory, contractual, training, and documentation requirements are met in line with sponsor timelines and NIHR best practices. This includes scheduling key meetings (e.g., Site Qualification and Site Initiation Visits), maintaining accurate documentation (e.g., training logs, CVs, ISF/Pharmacy files), and supporting preparation for greenlight approval.
In addition to trial start-up activities, the postholder will:
- Support the wider CRDC portfolio by circulating amendment documentation, tracking progress using systems such as EDGE and Kanbanchi, and facilitating effective cross-departmental communication.
- Coordinate site-specific meetings with research nurses and relevant support services (e.g., pharmacy, radiology).
- Ensure information is clearly disseminated to teams and that all staff are adequately trained and prepared for study delivery.
- Maintain oversight of SOP compliance and contribute to process improvement by providing feedback and identifying bottlenecks.
This role does not involve direct patient care, but rather ensures trials are set up for successful delivery by enabling streamlined, well-documented processes that meet sponsor and regulatory standards.
Job description
Job responsibilities
They will act as a key liaison for internal and external stakeholders involved in trial start-up, ensuring that all regulatory, contractual, training, and documentation requirements are met in line with sponsor timelines and NIHR best practices. This includes scheduling key meetings (e.g., Site Qualification and Site Initiation Visits), maintaining accurate documentation (e.g., training logs, CVs, ISF/Pharmacy files), and supporting preparation for greenlight approval.
In addition to trial start-up activities, the postholder will:
- Support the wider CRDC portfolio by circulating amendment documentation, tracking progress using systems such as EDGE and Kanbanchi, and facilitating effective cross-departmental communication.
- Coordinate site-specific meetings with research nurses and relevant support services (e.g., pharmacy, radiology).
- Ensure information is clearly disseminated to teams and that all staff are adequately trained and prepared for study delivery.
- Maintain oversight of SOP compliance and contribute to process improvement by providing feedback and identifying bottlenecks.
This role does not involve direct patient care, but rather ensures trials are set up for successful delivery by enabling streamlined, well-documented processes that meet sponsor and regulatory standards.
Person Specification
Experience
Essential
- Experience of working within the NHS or health service setting, particularly with multi-disciplinary teams including medical, nursing, and clinical support staff
- Demonstrable experience supporting clinical research, ideally including trial start-up activities (e.g. feasibility, site initiation, sponsor communications)
- Proficient in Microsoft Office applications (Word, Excel, PowerPoint, Outlook), particularly for document management, spreadsheets, and reporting
- Experience supporting administrative coordination across teams (e.g. booking meetings, preparing study packs, document control)
Desirable
- Experience in using research databases and digital platforms such as EDGE, Kanbanchi, or similar study tracking tools
- Familiarity with clinical trials regulatory frameworks (e.g. HRA, MHRA, GCP)
Skills
Essential
- Proficient in Microsoft Office and outlook software.
- Excellent written and oral communication skills.
- Able to prioritise and manage time efficiently
- Able to work on own initiative
- Proactive approach
- Effective organisational/diary management skills
Knowledge
Essential
- A willingness to undergo personal development and learn new skills
Qualifications
Desirable
- Educated to degree level, or equivalent, or be able to demonstrate relevant experience and training to commensurate with this post.Application form/ interviewD
- Clinical Research qualification - (ICH / GCP)
Person Specification
Experience
Essential
- Experience of working within the NHS or health service setting, particularly with multi-disciplinary teams including medical, nursing, and clinical support staff
- Demonstrable experience supporting clinical research, ideally including trial start-up activities (e.g. feasibility, site initiation, sponsor communications)
- Proficient in Microsoft Office applications (Word, Excel, PowerPoint, Outlook), particularly for document management, spreadsheets, and reporting
- Experience supporting administrative coordination across teams (e.g. booking meetings, preparing study packs, document control)
Desirable
- Experience in using research databases and digital platforms such as EDGE, Kanbanchi, or similar study tracking tools
- Familiarity with clinical trials regulatory frameworks (e.g. HRA, MHRA, GCP)
Skills
Essential
- Proficient in Microsoft Office and outlook software.
- Excellent written and oral communication skills.
- Able to prioritise and manage time efficiently
- Able to work on own initiative
- Proactive approach
- Effective organisational/diary management skills
Knowledge
Essential
- A willingness to undergo personal development and learn new skills
Qualifications
Desirable
- Educated to degree level, or equivalent, or be able to demonstrate relevant experience and training to commensurate with this post.Application form/ interviewD
- Clinical Research qualification - (ICH / GCP)
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.
