Clinical Trials Coordinator

The Newcastle upon Tyne Hospitals NHS Foundation Trust

The Clinical Ageing Research Unit (CARU) is based at CAV, delivering a portfolio of Industry and Academic clinical trials across all areas of Parkinson's 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 Parkinson's 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.

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 Principal 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 organisation 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.

Person Specification

KNOWLEDGE

• 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

• 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

• Ability to coordinate collection of data to agreed timescales.
• As a line manager, ability to handle Human Resources issues.
• 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

• Educated to degree level or equivalent experience/training or experience of working in clinical research with experience of conducting a research project.
• 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.