Sylvia Wertheim

Temporal job ,Home Based.Responsible for phases phase II, III, and IV. Preparation documentation of the pre-start of the trial. Double blind studies.Divises Trial All the activities related to monitoring. Review CRFs ,electronic data capture systems . Provide applicable updates Master File (eTMF) Complete final site close out visit and reports. Maintain a fluid and high-value relationship with researchers and with all personnel involved in clinical research.

Responsible for performing all activities of monitoring trials phase IV and administration of the center (MSN), Phone monitoring visits to ensure that the rights and welfare of human subjects are protected; the data from the reported trials are accurate, complete and verifiable from the documents of origin; EDC. This will be done in accordance with the study protocol, the applicable GCP / ICH / GEP, the Guidelines, applicable regulatory requirements, SOPs and other documentation requirements.

Freelance , contracted for Venezuela for an ongoing study, pre-closure follow-up activities, phase IV ,ophthalmology area, related to lent’s implants in Glaucoma.

Effective search of the medical literature in many databases and the critical analysis and evaluations of scientific evidence in Oncology and General Medicine areas, principles of Evidence Based Medicine. Analyzing , writing medical information. Responses to enquiries . Management of Opinion Leaders and important prescribers.Detect Adverse Event. All kind of Trainings Novartis had also to clousure many departaments including the Medical Information, and all the people had to leave the works.

Selection of sites.Documentation for the Dossier, Approvals of Ethics Committees of each site and Regulatory Approval for Health. Revision and translation of Informed Consent, Preparations for the start. Novartis had to clouse the Clinical Research departament in Venezuela due to the Political situation,Novartis asked me to move to the Medical Information Departament

Therapeutic areas oncology cardiology osteoporosis, colitis osteoarthritis rheumatoid arthritis diabetes multiple sclerosis devices dermatology lenses Implants vaccines respiratory diseases. Phases II III and IV Feasibility site selection initiation monitoring, motivational,close-out , audit support , startup activities documentations local approvals Training, mentoring CRAs investigator meetings.Co-monitoring activities ,coordinating Create and review documents

Ad Honorem - Design, coordination, planning, implementation and evaluation research projects of Mycology and Immunology training new staff in Laboratory Immunology and immuno-diagnostic of mycosis. Tutoring Advisory Medicine students Jury and Assessment of Academic Projects Thesis in: Mycology, Microbiology, Immunology and Cell Biology.

Development of a full academic career as a Professor and Researcher in the area of Medical Mycology , Research Coordinator at Fac. of Medicine ,Head of the Department of Microbiology , Planning and implementation of research projects, directly related to basic Mycology and Clinic Immunology of the mycosis.

Research Fellowship at Public Health Laboratory Service (Mycology Reference Laboratory (MRL), University of London .Researcher and Visiting Professor, for the Master Ph. Microbiology Students at the London University. UK.

Center for Disease Control (CDC) Atlanta, USA. Serodiagnosis of Fungal Deseases, Theoretical and practical,Different techniques for the diagnosis of deep mycosis, Formal Course ,15 days with Certification

in general Microbiology, Parasitology, Mycology, Immunology, Virology, Hematology, Biochemistry Specialised : basic Medical Mycology and Clinic Immunology of the mycosis.