Clinical Trial Coordinator-Regulatory

Job Description

Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.
The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities. The role will collaborate at local level closely with COM, CRM and CRA.

Responsibilities include, but are not limited to:

• Trial and site administration:

o Track (e.g. essential documents) and report (e.g. Safety Reports)
o Ensure collation and distribution of study tools and documents
o Update clinical trial databases (CTMS) and trackers
o Clinical supply & non-clinical supply management, in collaboration with other country
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