Description

of Roles and Responsibilities

• Trial and site administration :

o Tracking (e.g. essential documents) and reporting (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 roles

o Manage Labeling requirements and coordinate/sign translation change request

• Document management:

o Prepare documents and correspondence

o Collate, distribute/ship, and archive clinical documents

o Assist with eTMF reconciliation

o Updating manuals/documents (e.g., patient diaries, instructions)

o Document proper destruction of clinical supplies.

o Prepare Investigator trial file binders

o Execute eTMF Quality Control Plan

o Obtain translations of documents

•...