francesco roselli

* Management of the unit responsible for the execution of the clinical monitoring activities for all oncology studies sponsored by the CHUV. * Line management and supervision of in-house clinical monitors. * Setup of Quality Documents. * Execution of internal Quality Control activities. * Provide guidance on clinical monitoring aspects and provide clinical monitoring-related trainings. * Study Phases: I-II. * TAs: oncology/immuno-oncology

* Support to the Head of Clinical Operations in the supervision and execution of clinical trials conducted at the Clinical Investigation Unit / Center for Experimental Therapeutics of the Oncology department. * Line management and supervision of in-house clinical research coordinators. * Execution of internal Quality Control activities. * Provide guidance on clinical monitoring aspects and provide clinical monitoring-related trainings. * Creation of clinical study budgets. * Study Phases: I-II-III. * TAs: oncology.

* Responsible for the management and supervision of the clinical monitoring and regulatory start-up activities in a mega-Post Authorization Safety Study with 34 countries/500 centres/30.000 patients. Lead and coordination of the whole CRA team, composed by both internal and freelance personnel, reporting to internal and sponsor study teams as representative of the clinical monitoring department. * CRA budget control responsibility. Interfacing with internal departments (e.g. Legal etc.). * Study Phases: Post Marketing/Observational. * TAs: ophthalmology.

* Independently responsible for setup, full management and continuous monitoring of the central laboratory services requested by pharmaceutical clients for their clinical trials, in order to meet clients’ expectations and timelines. * First line contact with clients for all central lab testing-related issues. * Budget monitoring and coordination/supervision activity with/on internal departments. * Study phases: I-II-III. * TAs: oncology, muscle-skeletal, HIV, CNS.

* Independently covering all aspects of the clinical monitoring activity, from Ethics Committee submissions to initiations, monitoring and closures, translations, with full site responsibility and acting as local client contact for all trial-related matters. * Site management according to study and client requirements, co-monitoring activities. * Monitoring multi-center clinical studies in Switzerland and Italy. Taking over partial study activities upon clients’ request, e.g. review of essential documents prior to closing sites, manpower cover on short notice e.g. maternity cover or leave of monitor. * Study phases: II-III-IV. * TAs: cardiovascular, oncology, diabetes, CNS.

Graduation thesis project: decrease of virulence of pathogens (such as S.typhimurium) by study of the effects of heterologous membrane-located desaturases on plasmatic membrane state and shock response. Laboratory skills: sequencing, gel electrophoresis, Echardt assay, nucleic acids extraction and precipitation, cloning, mapping, restriction enzymes use, handling of pathogens such as E.coli, S.typhimurium, techniques of sterile culture, cloning strategies setup, use of plasmid vectors, transformation, use of spectrophotometers etc.).