Nina SAMO

Managing international studies on oncology : - performing site initiation visits - monitoring visits - site closures Attending investigator meetings

Clinical Research Associate on orthopaedic Surgery and Neurology · management of a monocentric clinical study based on biological samples · managing a database of all surgeries with neurological disorders · Setting up and update of all the study documents · logistics of biological samples and Data collection · Permanent contact with investigators

- Data collection and validation - Management of clinical trial samples (sending, accountability, storage) and site material - Setting up and update of all the study documents (flowcharts, follow up of inclusions) - Biology Central Lab Training (training of study nurses) and interaction with the Central Lab (follow-up, queries, lab kit…) - Interaction with the Data Management - Management and reporting of AEs - Travel arrangements

• Review of Protocol, CRF and other studies documentations • Creation and update of the TMF and other study files • Initiation, on-site monitoring visits and close-out of investigational sites. • Using of e-CRF and paper-based CRF • Drafting of visits reports •Drafting of visit reports • Permanent contact with investigators

 Document’s designing: protocol, CRF, Informed Consents Forms, TMF  Initiation, Monitoring, Close-out  Management of clinical trial treatment (sending, accountability, storage) and site material  Biology Central Lab Training (training of study technicians) and interaction with the Central Lab (follow-up lab alert, queries, lab kit…)  Interaction with the Data Management (queries and intermediate analysis)  Submission of protocol and consent documents to AFSSAPS and local Ethics committee

Regulations on clinical trials, GCP-ICH, role of a CRA, Pharmacology, toxicology, drug development, drug safety.

drug development, formulation, industrial processes, clinical research, marketing, quality insurance, business and project management