Clinical Trial Administrator
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| Job Type | Permanent Full Time |
| Location | United Kingdom |
| Area | EMEA (other), Rest of World |
| Sector | Science |
| Salary | www.pop-science.co.uk |
| Currency | gbp |
| Start Date | ASAP |
| Advertiser | remoteapi |
| Job Ref | 821 |
| Job Views | 256 |
- Description
Clinical Trial Administrator
This is a 6-week contract role for a Clinical Trial Administrator who will be supporting my client's Drug Development Unit (DDU) and Clinical Trial Management Team through the completion of administrative tasks. Basic knowledge of ICH GCP is preferable.
Principal Duties:
- Managing the creation, maintenance and archiving of the Investigator Site File (ISF)
- Preparation of the ISF for Sponsor's monitors
- Maintains and tracks clinical trial documentation ensuring they meet GCP standards
- Presents SUSAR reports to research team and tracks review
- Compile study documentation as requested by the Sponsor
- Ad hoc duties/projects as directed
- To gain a full understanding of the client's relevant SOPs
- Maintain awareness of HCA policy and procedures relating to the post holder's role
- Maintain up to date mandatory training and attend other training as relevant to the position.
This job description gives a general outline of the post and is not intended to be inflexible or a final list of duties. It may therefore be amended from time to time in full consultation with the post holder.
Requirements
In order to perform the post holder will need:
- Preferably degree educated in a biological science / business administration or related discipline
- Have some experience and knowledge of cancer clinical trial methodology including the conduct of early trials.
- Excellent oral and written communication skills
- To communicate with managers and staff at all levels
- To liaise with Consultants and laboratories
- Knowledge and experience with clinical data and ICH Good Clinical Practices
- Strong attention to detail
- Good organisational, planning and time management skills
- Able to work under minimal indirect supervision
- Must maintain a high standard of practice in accordance with company policy and procedure
- Experience with Microsoft Office applications for document, presentation and spreadsheet preparation
- Good standard of literacy and numeracy.
- Attention to detail
- Clerical / administrative and organizational skills