Trial and site administration: Track (e.g. essential documents) and report; Ensure collation and distribution of study tools and documents
Document management: Prepare documents and correspondence; Collate, distribute/ship, and archive clinical documents, e.g. eTMF; Assist with eTMF reconciliation; Execute eTMF Quality Control Plan Site Start-Up responsibilities: Collaborate with other country roles to provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions; Obtain, track and update study insurance certificates Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives to develop, control, update and close-out country and site budgets; Develop, negotiate, approve and maintain contracts (e.g. CTRAs); Track and report contract negotiations; Update and maintain contract templates; Calculate and execute payments; Ensure adherence to financial and compliance procedures; Monitor and track adherence and disclosures; Maintain tracking tools S/AE Claim Management: Support Financial Clinical Operation Manager for coordinating meetings, maintaining tracking tools, developing and maintaining settle agreements, coordinating payments, and collating/distributing/archiving documents