Job Description
Responsibilities include, but are not limited to:
• Trial and site administration:
o Track (e.g. essential documents) and report
o Ensure collation and distribution of study tools and documents
• 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
• Site Start-Up responsibilities: Collaborate with other country roles to:
o In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up
and submissions
o Obtain, track and update study insurance certificates
• 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 ...
• Trial and site administration:
o Track (e.g. essential documents) and report
o Ensure collation and distribution of study tools and documents
• 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
• Site Start-Up responsibilities: Collaborate with other country roles to:
o In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up
and submissions
o Obtain, track and update study insurance certificates
• 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 ...