Yen Hamou Ingrid Otoidobiga

Clinical Research Associate @CHU de Poitiers

Poitiers, FR

I ensure the administrative and logistical management of clinical studies, in compliance with the sponsor\'s procedures and Good Clinical Practices. • I assist in the preparation and/or creation of study-specific documents/procedures prior to study initiation• I take part in and/or help with the feasibility and selection of centers;• I prepare and/or help to finalize investigator binder documents for the opening of centers/transmission to centers.• I carry out study follow-up in the investigator centers and pharmacies, in accordance with the sponsor\'s procedures. • I take part in and set up the study in the investigating centers, including e-CRF training, updating the investigator\'s file, writing the set-up report and follow-up letter;• I carry out study monitoring adapted to the monitoring plan• Verification of notification of EvIGs to the Vigilance Unit (UVEC) and their follow-up.• I ensure regular communication with the centers to relaunch inclusions if necessary and ensure quality data collection;• I carry out pharmacy monitoring adapted to the monitoring plan Closure of investigator centers: on site or by telephone;• I ensure administrative and regulatory management of trials in accordance with established internal procedures • I update the study sponsor file (electronic and paper TMF);• I update the inclusion tracking table and the monitoring visit tracking table.• I participate in the transmission of updated study documents to the associated centers, in particular following Substantial Modifications after regulatory approvals;• I check data entry with the data management department,• I monitor data entry by the centers and alert the Project Manager to any significant delay in data entry;• I monitor the resolution of queries with the center and data management;