Senior Clinical Trial Assistant - Cardiff

CK Clinical
Cardiff (Caerdydd)
£25000 to £30000
02 Dec 2017
08 Dec 2017
Contract Type
Full Time
Lucy Stendall is recruiting for a Senior Clinical Trials Assistant to join a Global Biopharmaceutical company, based in Cardiff, on a full time permanent basis. Our Client is a fast growing specialist biotech company who are leading the development of treatments for Chronic Endocrine Conditions, on an international level.

As a Senior Clinical Trials Assistant, you will have the following requirements and responsibilities:
- Organise, maintain and complete the paper and electronic trial master files, including collation of study documents from monitors or CROs and appropriate filing of documents.
- Identify and prepare documents for study sites or for regulatory and ethical submissions as needed.
- Periodically, and at the end of the study, review study files / folders for organization and completeness.
- Review the pre-audit, pre-inspection or pre-archiving of the study files / folders to ensure their quality and completeness.
- Assist in setting up clinical study files / folders at study sites and assist in quality review of the study site files / folders throughout the study.
- Assist the clinical operations project managers, by offering support for day-to-day study management activities.
- Conduct in-house clinical operations functions, including clinical supplies coordination, vendor contract and payment coordination, investigator meeting preparation and coordination, document processing and study status tracking.
- Arranging internal and external meetings and taking and distributing minutes.
- Arranging and minuting Study Team Meetings (as required) and completing actions as necessary.
- Assist in the project management and monitoring of clinical studies, including liaison with study sites, monitors, CROs, drug vendors, central laboratories and other vendors for study related tasks.
- Maintaining the project timeline.
- Maintaining budget tracking tools as appropriate.
- Providing study status reports as requested.

As a Clinical Trials Assistant, you will have the following qualifications, skills and experience:
- Scientific background, ideally educated to degree level.
- Previous experience working within a pharmaceutical/ CRO environment.
- Organised and have good time management skills.
- Good attention to detail.
- Familiar with regulatory procedures.
- Able to produce high quality work to agreed deadlines
- Aptitude for clinical systems related work (Microsoft office, EXCEL) electronic/paper filing.
- Good interpersonal skills, written fluency in English.
- Good attention to detail essential.
- Experience of working in the clinical research & demonstration of excellent organisational, technical and verbal/written communication skills
- Ability to work in a busy & changing environment, with a proven ability to prioritise, use initiative and work to deadlines under pressure is also important.
- Strong IT skills. Demonstrate you are adept in learning and using relevant computer applications.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL40638 in all correspondence.