Job summary
The Clinical Ageing Research Unit (CARU) is based at CAV, delivering a portfolio of Industry and Academic clinical trials across all areas of Parkinsons Disease and neurodegeneration.
We are looking to recruit an enthusiastic Clinical Trials Coordinator to join the CARU Team. The post offers a unique opportunity to join a supportive team.
You will work predominately with Professor Pavese focusing on Parkinsons disease studies with a major input on the Michael J Fox The Parkinson's Progression Markers initiative (PPMI).
The successful candidate will collaborate with research teams in the set-up, delivery and close down of clinical trials. Liaising with internal and external departments to ensure clinical trials are set-up and delivered in accordance with Good Clinical Practice, the Research Governance Framework and the Data Protection Act.
Strong organisational and interpersonal skills and a high degree of accuracy are essential for this role together with the ability to manage an extensive workload.
- Interview date: Tuesday 13 May 2025
- 37 hours 30 minutes/week
- You will be redirected to Trac to apply for the vacancy. Please expand the job details section and read all of the information before applying for the vacancy.
NO AGENCIES PLEASE
Main duties of the job
As a Clinical Trials Coordinator in the CARU Team you will:
- Provide guidance and support for Principal Investigators, sharing knowledge of best practice and current legislation/guidance
- Liaise with internal and external stakeholders and vendors.
- Prepare submission to IRAS/HRA together with Principle Investigator.
- Prepare submissions to R&D
- Ensure all trials will have received full ethical and Trust approval before being opened to recruitment
- Disseminate new protocols and amendments (following approval) to relevant research personnel
- Develop and maintain trial site and participant files
- Provide Data management input when required.
- Provide support for organistaion of patient related events.
- Raise invoices to ensure all study costs are recovered for the Trust
- Undertake study close-out and archiving activities following Trust SOPs
- Provide support for creation of study visits.
This list is not exhaustive and you are strongly encouraged to carefully review the Job Description for further information and in particular to ensure you meet all of the Essential requirements for the role.
About us
Our staff oversee over 6,500 patient contacts every day, delivering high standards of healthcare from the following sites:
o Freeman Hospital
o Royal Victoria Infirmary (RVI)
o Health Innovation Neighbourhood (on the former Newcastle General Hospital and Centre for Ageing and Vitality site)
o Newcastle Dental Hospital
o Newcastle Fertility Centre
o Northern Centre for Cancer Care, North Cumbria
o Northern Genetics Service
o Cramlington Manor Walks
These include a range of flagship services which deliver cutting-edge care (supported by state-of-the-art diagnostic services in both radiology and pathology) and are a catalyst for innovation to support pioneering clinical practice in the NHS.
We also have offices at Regent Point in Gosforth and community sites.
Please see attached information on what Staff Benefits we have to offer at our Trust under 'Documents to download' or 'Supporting documents'.
For further information on The Newcastle upon Tyne Hospitals NHS Foundation Trust please visit: Careers | Newcastle Hospitals | NHS | Newcastle Hospitals and Newcastle Hospitals NHS Foundation Trust
Job description
Job responsibilities
- To ensure any trials within the post holders remit, carried out in the Clinical Trials Unit are properly conducted according to Good Clinical Practice (GCP), Research Governance Framework and are compliant with the EU directive for clinical trials. (There can be multiple trials at any given time, in various stages of preparation, inception and completion.)
- All events pertaining to the treatment of said patients are reported in the agreed timeframes to relevant external trials organisations.
Job description
Job responsibilities
- To ensure any trials within the post holders remit, carried out in the Clinical Trials Unit are properly conducted according to Good Clinical Practice (GCP), Research Governance Framework and are compliant with the EU directive for clinical trials. (There can be multiple trials at any given time, in various stages of preparation, inception and completion.)
- All events pertaining to the treatment of said patients are reported in the agreed timeframes to relevant external trials organisations.
Person Specification
KNOWLEDGE
Essential
- Knowledge and expertise regarding the mandatory standards regarding conduction/construction of clinical trials (to include GCP/Research Governance Framework/EU Directive/Data Protection Act)
- Understanding of Trust confidentiality procedures (Data Protection Act, Caldicott guidelines)
- Knowledge of medical terminology
SKILLS
Essential
- Excellent inter personal skills
- Ability to communicate well (written and verbally)
- Advanced IT skills, specifically in database management and use of Microsoft Office applications
- Ability to use computer software to create and/or develop reporting tools.
- Clear and legible handwriting.
EXPERIENCE
Essential
- Ability to coordinate collection of data to agreed timescales
- As a line manager, ability to handle Human Resources issues
Desirable
- Evidence of any education related training programmes pertaining to clinical trials
- Experience of patient management systems i.e. eRecord and electronic data capture systems
Qualifications
Essential
- Educated to degree level or equivalent experience/training or experience of working in clinical research with experience of conducting a research project
Desirable
- European Computer Driving Licence
Person Specification
KNOWLEDGE
Essential
- Knowledge and expertise regarding the mandatory standards regarding conduction/construction of clinical trials (to include GCP/Research Governance Framework/EU Directive/Data Protection Act)
- Understanding of Trust confidentiality procedures (Data Protection Act, Caldicott guidelines)
- Knowledge of medical terminology
SKILLS
Essential
- Excellent inter personal skills
- Ability to communicate well (written and verbally)
- Advanced IT skills, specifically in database management and use of Microsoft Office applications
- Ability to use computer software to create and/or develop reporting tools.
- Clear and legible handwriting.
EXPERIENCE
Essential
- Ability to coordinate collection of data to agreed timescales
- As a line manager, ability to handle Human Resources issues
Desirable
- Evidence of any education related training programmes pertaining to clinical trials
- Experience of patient management systems i.e. eRecord and electronic data capture systems
Qualifications
Essential
- Educated to degree level or equivalent experience/training or experience of working in clinical research with experience of conducting a research project
Desirable
- European Computer Driving Licence
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).
