The Newcastle upon Tyne Hospitals NHS Foundation Trust
The NIHR Newcastle Clinical Research Facility (NCRF) delivers high-quality, cutting-edge experimental medical research and early phase clinical trials across a wide range of speciality areas. The NCRF is established by the partnership between Newcastle University and the Newcastle upon Tyne Hospitals NHS Foundation Trust, both founding members of the Newcastle Health Innovation Partners, one of only eight Academic Health Science Centres in the UK.
NCRF is looking for a Clinical Trial Coordinator to join the team, to support the set-up and delivery of the wide portfolio. This role will be based within the Royal Victoria Infirmary Research Unit (RVRU), Leazes Wing, Royal Victoria Infirmary.
Main duties of the job
The successful candidate will be highly motivated with excellent communication and interpersonal skills. Working in a busy environment with a commitment to collaboration, along with knowledge of Good Clinical Practice, Research Governance Framework and Data Protection Act. You will be able to demonstrate advanced IT skills particularly Microsoft Office. This is a demanding role which requires an organised individual with the ability to work under pressure.
Job responsibilities
* 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
* 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.
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