Clinical Trials Co-ordinator

Job summary

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.

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.

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.

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

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.

Certificate of Sponsorship

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.