Gabriela Stamatescu

Medical Monitor @Seriant (formerly MHICC)

CA

As a medical monitor I have the responsibility to- review and provide input about the clinical study protocol- review and provide input on other study related documents (eCRF, completion guidelines, adverse events and endpoints completion guidelines, data management plan)- review the patients\' eCRF (InForm) data and the documents related to the reported events- generate DSMB and CEC charters and follow-ups to ensure committee composition completed- provide training and assistance to the members of the adjudication committees (chairman and the independent reviewers)- manage the adjudication committees and ensure that all potential endpoints/events are adjudicated, as specified in the clinical study protocols- ensure medical consistency, accuracy, and validity of the clinical study data as per Regulatory requirements and internal SOPs- participate to the Investigators\' Meetings- provide training and/or guidance to the site staff, the Clinical Research Associates and to the MHICC staff- generate the medical monitoring and safety plan- report SUSARs to the Regulatory Authorities within the required timelines- write narratives for SUSARs, SAEs and other adverse events, as specified in the study protocol- review and approve the medical coding.