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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 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 ● S/AE Claim Management: Support Financial Clinical Operation Manager(F-COM) for: o Coordinate meetings o Update and maintain tracking tools o Develop and maintain settle agreements o Coordinate for payments o Collate, distribute/ship, and archive relevant documents