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Job Description
The Role
To provide administrative support for the Project Management groupTo comply & adhere to GXP guidelines and regulations as required of this role.
This is a 12 month fixed term contract
Main tasks and responsibilities
Assist in production and formatting of various study documentation including, but not limited to study worksheets, subject lists and client summaries
Investigator Site File and eTMF set up and maintenance
Complete and initiate TMF QC (paper and electronic)
Set up and filing into client Trial Master Files (electronic or paper) where requested by clients
Maintenance of delegation logs
File Note control and filing
Breakdown of files ready for archiving
Provide support to monitoring visits as needed
Study specific document issue and recall e.g. protocols, informed consent documents, blinding plans, risk management plans
Set up of the clinical study folder, dispensary study folder, laboratory study folder and recruitment study folder
Additional Tasks/responsibilities
Administrative support to other groups within Quotient Sciences as required such as reception cover, assist with ethics submission documentation, SOP administration etc. Assist in the delivery of studies within the clinic by completing cross training requirements and performing procedures which include but are not limited to vital signs, ECGs, blood sampling and dosing where applicable.
Qualifications and experience required for competent performance
Minimum GCSE/ ’O’ Level English Language or equivalent
Good computer skills including word processing and the use of databases
