Daniel Herta Email & Phone Number

MONTREAL HEART INSTITUTE COORDINATING CENTER (MHICC), Montreal, QuebecClinical Trial Assistant, Clinical Research, January 2009 - Present• Act as a resource person for Project Managers for the development and update of the investigators' central database for clinical studies;• Assist and support the operations of Project Managers so that studies are in conformity with Good Clinical Practice and internal SOPs;• Coordinate with the clinical project team the distribution, retrieval and review of regulatory documents required for initiation of clinical trial;• Assure currency of required clinical trial documents within central files throughout the clinical trials;• Maintain clinical grant tracking database for each study, generates periodic reports on status of grant payments and resolve payment inquiries from sites;• Assist Project Manager/CRA in preparing and tracking investigational product (IP) supplies, packaging and shipment requests;• Assist in securing necessary administrative (non-drug) supplies for clinical trial and processes site request for shipping;• Set-up, populate and maintain clinical trial monitoring/management tracking systems;• Ensure filing and document management of all correspondence between all participants in the studies;• Organize and assist the activities of various meetings of clinical studies;• Ensure sites closure and documents archiving according to regulatory requirements and internal SOPs;• Data entry in eCRF database; Management of users in Patient Randomization/IWRS SoftwareMONTREAL HEART INSTITUTE COORDINATING CENTER (MHICC), Montreal, QuebecAdministrative Technician, Accounting, January 2010 - April 2011• Analyze vendors' contracts in order to understand the liability of the parties and to authorize the payment of the invoices received;• Investigate any discrepancies between the contracts and the invoices;• Prepare invoices according to work performed and according to the sponsor contract;• Assist the Accountant and the team in the execution of financial and administrative tasks.EDUCATION• Attestation of College Studies (AEC en soutien administratif) Maisonneuve College, Montreal, Canada, 2007-2008• Master's in Public Administration, École nationale d’administration publique (ENAP), Montreal, Canada, 2003-2005

Listed skills include Regulatory Affairs, Clinical Trials, Clinical Research, Pilotage Du Changement Organisationnel, and 4 others.