Determine est un éditeur qui propose des solutions de gestion des processus et des problématique métiers : finance, achat, comptabilité, légal, contrôle de gestion et traitement des factures.
in addition responsible for CROs oversights (Quality Assessment Visit) to ensure approved Quality Management Plans are followed. Review and approval of Site Monitoring reports and Quality Assessment Reports, Site Budget negotiation and Support to Protocol Director/Director of Clinical Operations. Lead CRA for co-sponsored TB vaccine study (Aeras and GSK) and performed pre-site assessment visits, site selections and sites budget negotiation. Member of the Aeras team to select for the winning Bidding CROs for Lab activities and Protocol monitoring contracts.
at AERAS Global TB Vaccine Foundation. Performs and coordinates assigned aspects of the clinical monitoring processes in accordance with ICH-GCPs/Regulatory authority and IRBs/IECs rules and SOPs to assess the safety and efficacy of AERAS TB vaccines candidates currently under clinical trials globally. Provide training supports i.e. Protocols, ICF, Quality Management Plan, Source documentations, Site Trainings, etc. to selected sites. Research Pharmacy and Laboratory Audits. Furthermore, in countries where the monitoring activities are performed by a client company (Clinical Research Organization), supervise and coordinate the client company Clinical Research Associate activities with regards to the trial requirements.
Performs and coordinates assigned aspects of the clinical monitoring process in the Therapeutics Research Program (TRP) reported under the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) and the Adult AIDS Clinical Trials Group (AACTG) networks, the Prevention Sciences Program (PSP) reported under the Microbicide Trials Network (MTN), the Vaccine Research Program (VRP) reported under the HIV Prevention Trials Network (HVTN) and HIV Vaccine Trials Network (HPTN) and the Basic Sciences Program (BSP) network for the Division of AIDS (DAIDS). Research Pharmacy and Laboratory Audits. 75% of my job is traveling to research sites funded by NIH/DAIDS across the whole African continent.
Performs and coordinates assigned aspects of the clinical monitoring process in accordance with ICH-GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices. Conducts site visits (Assessments, Initiations, Interim Monitoring visits, Close out Visits) to determine protocol and regulatory compliance, and prepares required documentation. Develops collaborative relationships with investigative sites and client company personnel. Research Pharmacy and Laboratory Audits. 75% of my job is traveling to research sites funded by NIH/DMID across the whole African continent.