HEALTHCARE MANAGMENT ASSOCIATE IN INDIA

Working in coordination with Principal Investigator and study team to conduct trial in accordance with protocol, ICH GCP and regulatory requirement. Maintain and Update site file in accordance with GCP and Sponsors SOP. Provide update on patient recruitment PI, Sponsor and CRO. Assist PI to Managing (timely manner reporting and updating) the adverse events, adverse event of special interest & serious adverse events to CRO, Sponsor and E.C. Assist PI to report SAE, Death reporting, endpoint reporting to the Sponsor and helping the PI in transcribed these events in EDC or paper CRF. Assist PI in making of narrative of these events. Monitored all source documents, Lab reports, Medical records and all study related records before transcribe eCRF and CRO monitoring. Facilitate monitoring visit and prepare the required documents for monitoring visit. Make documents available for monitoring visit. Case Report Form (both eCRF and Paper CRF) completion according to the CRF completion Guidelines. Scheduling & Organizing Patient s follow up visits. Maintain communication between the sponsor, site and ethics committee. Resolution of DCF Resolution of queries