Clinical Trial Coordinator

Responsibilities:•    Trial and site administration:o    Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)o    Ensure collation and distribution of study tools and documentso    Update clinical trial databases (CTMS) and trackerso    Clinical supply & non‐clinical supply management, in collaboration with other country roleso    Manage Labeling requirements and coordinate/sign translation change request•    Document management:o    Prepare documents and correspondenceo    Collate, distribute/ship, and archive clinical documentso    Assist with eTMF reconciliationo    Updating manuals/documents (e.g., patient diaries, instructions)o    Document proper destruction of clinical supplies.o    Prepare Investigator trial file binderso    Execute eTMF Quality Control Plano    Obtain translations of documents•    Regulatory & Site Start‐Up responsibilities:o    In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start‐up and submissionso    Obtain, track and update study insurance certificateso    Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.o    Publish study results for GCTO and RA where required per local legislation•    Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives for:o    Develop country and site budgets (including Split site budget)o    Tracking, and reporting of negotiationso    Maintenance of tracking toolso    Working knowledge of Contract development, negotiation, approval and maintenance (e.g. CTRAs)o    Update and maintain contract templates (in cooperation with Legal Department)o    Payment calculation and execution (investigators, vendors, grants)o    Ensure compliance with financial procedureso    Monitor and track adherence and disclosureso    Budget closeout.o    Obtain and process FCPA documentation in a timely manner•    Meeting Planning:o    Organize meetings (create & track study memos/letters/protocols)o    Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable

Requirement:*B.A./B.S. (Life Science preferred) or equivalent healthcare experience;*Minimum 1‐2 years in Clinical Research or relevant healthcare experienceNote ‐ Specific experience requirements may vary depending on the Country