MSD Senior Clinical Trial Coordinator 

Brazil, Federal District 

94096553

Job Description

This role is responsible for comprehensive trial and site administration. Under the oversight of theSenior COM or COMs or CTCManager, the person prepares, collates, distributes and archivesclinical documents.CTC supportsclinical supply & non-clinical supply management and ensuresmaintenance of tracking and reporting tools, as applicable.

The role is critical to meet planned Site Ready dates, includingassisting with thepreparation ofsubmission packages to IRBrepresentatives to manage CTRAs and payments.

Current Contingent Workers apply

Language(s) Job Description:

Responsibilities include, but are not limited to:

Trial and site administration:

Track (e.g. essential documents) and report (e.g. Safety Reports)

Ensure collation and distribution of study tools and documents

Update clinical trial databases (CTMS) and trackersClinical supply & non

Manage Labeling requirements and coordinate/sign translation change request

Document management:

Prepare documents and correspondenceCollate, distribute/ship, and archive clinical documents, e.g. eTMFAssist with eTMF reconciliationExecute eTMF Quality Control PlanUpdate manuals/documents (e.g., patient diaries, instructions)

Document proper destruction of clinical supplies.

Investigator trial file bindersObtain translations of documents

Regulatory & Site Start-Up responsibilities:In a timely manner, provide to and collect from investigators forms/lists for sitesite start-up and submissions

Obtain, track and update study insurance certificates

Support preparation of submission package for IRB/ERC and support regulatoryagencies submissions.

Publish study results for GCTO and RA where required per local legislati

No Travel Required

Not Indicated

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.