Maria Fernanda Cruz Ibarra Email & Phone Number

Ciudad De México, México

Mexico City Area, Mexico

• Setting up vendors during study start up period (operational details from sites)• Enter necessary data / tracking in systems (i.e.ECLIPSE, eTMF, SAP) • Responsible for documentation within the electronic master file (uploading / completing documents) & other systems (i.e., document exchange portals like Mytrials/Shared Investigator Portal) including conduct of completeness checks• Complete all payment activities including preparing invoices, Payment Due Reports and creating fund/PO• Collect and distribute documents from / to sites during study life cycle • Coordinate study related materials (i.e. protocol, Informed Consent Form(ICF), patient material) for translation • Coordinate study related documents (IB, Protocol, Site ICF etc.) for printing and binding• Administrative support to the study team (study related mailing, bill processing, printing, translation etc.)• Obtain Insurance certificates • Preparing On Site Investigator File and other study related files• Support equipment calibration and tracking• Archiving process handling at study closure• May support Local GRS in preparing and/or performing submission for Health Authorities including follow up until approval. This could include preparation and/or submission of substantial amendments.• May prepare and perform submission for Ethics Committees including follow up until approval (protocol, amendments/IB)• May support Health Authority inspection and pre-inspection activities• May support audit preparation & Corrective Action / Preventative Action preparation for local related issues