MSD Sr Clinical Trial Coordinator 

Guatemala, Sacatepéquez, Antigua Guatemala 

970652467

Job Description

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 trackerso Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)

• Document management:
o Prepare documents and correspondence
o Collate, distribute/ship, and archive clinical documents, e.g. eTMF
o Assist with eTMF reconciliation
o Execute eTMF Quality Control Plan
o Update manuals/documents (e.g., patient diaries, instructions)
o Document proper destruction of clinical supplies.
o Prepare Investigator trial file binders
o Obtain translations of documents

• Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:
o In a timely manner, provide to and collect from investigators forms/lists forsite evaluation/validation,site start-up and submissions
o Obtain, track and update study insurance certificates
o Support preparation of submission package for IRB/ERC and supportregulatory agenciessubmissions

• Budgeting, Agreement and Payments:
Collaborate with finance/budgeting representatives for:
o Develop, control, update and close-out country and site budgets (including Split site budget)
o Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
o Track and report contract negotiations
o Update and maintain contract templates (in cooperation with Legal Department)
o Calculate and execute payments (to investigators, vendors, grants)
o Ensure adherence to financial and compliance procedures
o Monitor and track adherence and disclosures
o Maintain tracking tools
o Obtain and process FCPA documentation in a timely manner

Current Contingent Workers apply

*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.