Clinical Trials Co-ordinator

We are looking for a highly motivated individual with proven ability in the coordination of clinical trials, to join the trial coordination team at the John Walton Muscular Dystrophy Research Centre, a multidisciplinary team working in translational research for neuromuscular diseases. You will deliver your role across the John Walton Muscular Dystrophy Research Centre and the Clinical Research facility at the Royal Victoria Infirmary.

The purpose of this varied and challenging post is to manage a large portfolio of clinical research including national history studies and clinical trials. The post holder will be expected to oversee all clinical research projects from protocol development to end of study, ensuring that all regulatory approvals are in place and that Good Clinical Practice is followed throughout a study. You will be coordinating all the John Walton Muscular Dystrophy Research Centre clinical trials delivered in the Clinical Research facility at the Royal Victoria Infirmary.

• Interview Date: Tuesday 11 February 2025
• 37 Hours 30 Minutes/Week

NO AGENCIES PLEASE

Main duties of the job

• The post holder will provide guidance and support for Principal Investigators, sharing knowledge of best practice and current legislation/guidance.
• Ensuring all trials within the post holder's remit, run within the unit, have received full ethical and Trust approval before being opened to recruitment.
• Overseeing and assisting in the timely completion of Case Report Forms (CRFs) to reflect ongoing status of patients on trials.
• Responsible for reporting of any Serious Adverse Event (SAE) affecting patients enrolled into a clinical trial within required timeframe (usually 24 hours).
• Receipt and dissemination of new protocols and amendments within the centre (following approval) to relevant clinical areas.
• Maintenance of appropriate records to reflect this.
• Coordinate protocol review process within the centre.
• Development and maintenance of trial site files.
• Updating and maintaining centralised patient database.
• Providing timely information and reports to reflect recruitment of patients.
• Understanding NHS and University costing processes in order to coordinate and manage complex costings for clinical trials and grant applications.

About us

Our staff oversee over 6,500 patient contacts every day, delivering high standards of healthcare from the following sites:

• Freeman Hospital
• Royal Victoria Infirmary (RVI)
• Health Innovation Neighbourhood (on the former Newcastle General Hospital and Centre for Ageing and Vitality site)
• Newcastle Dental Hospital
• Newcastle Fertility Centre
• Northern Centre for Cancer Care, North Cumbria
• Northern Genetics Service
• 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

Job description

Job responsibilities

This role is an opportunity to build on existing skills in trial coordination and gain experience of advanced and gene therapy trials.

You will therefore be expected to have relevant experience of clinical trial coordination and the associated regulations and processes. You should be an excellent communicator, with a proven ability to use initiative and plan workload effectively.

• To ensure any trials within the post holder's 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.

As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you.

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 interpersonal 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

Employer details

Employer name

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Address

Trustwide

317 Trustwide

NE1 4LP

Any attachments will be accessible after you click to apply.

317-2024-53-015