Massimo Duranti

Descrizione

"Description of all specific activities: Contribute to Project Management team activities, including co-ordination and implementation, for designated clinical trials and to monitor specified sites to ensure quality and integrity of data, compliance with relevant SOPs and regulatory requirements. Develop and maintain a full and detailed understanding of the protocol, study procedures and any other study-specific requirements for designated projects. Conduct pre-study site and initiation visits for the designated sites. Conduct monitoring visits at the sites, performing all the assigned tasks according to the project specific monitoring manual and ICH-GCP, including the check of the accuracy and completeness of the CRFs entries, source document and other trial-related records against each other. Ensure that the investigators and other study staff are aware of and comply with the study protocol, procedures and SOPs and with GCP and other regulatory requirements. Maintain regular communication with the sites, report in writing all sites visits and other contacts, ensuring that the Clinical Project Manager is informed of the study progress and/or any problems with the sites. Contribute to the in-house review of Case Report Form and to perform queries resolution, both in-house and at the sites. Conduct close-out visit at the designed sites Reports the contents, actions and recommendations of the Visits to the PM/ CRAM in compliance to the Sponsor's SOP requirements."

Curriculum vitae

"PERSONAL INFORMATION Name MASSIMO DURANTI Address 12 S. ALTAMURA RD, 80128 - NAPOLI
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ITALY mobile +39 333 5662027 Fax +39 (0)81 2140340 E-mail massimo_duranti@fastwebnet.it dottoremax@gmail.com Nationality Italian WORK EXPERIENCE JULY 2004-Present Clinical Research Specialist (& SCIENTIFIC MARKET SURVEY PROMOTER)FREE LANCE EXPERIENCE IN THERAPEUTICAL AREAS: Cardiovascular, Pulmonary, Metabolic diseases and Endocrinology, Neurology, Infectious diseases, Dermatology, Gastroenterology, Oncology, Urology, Psychiatry, SNC, Medical devices (especially cardiac and neurosurgical) Principal Employers: Pierrel Group, Pharm-Olam, Quintiles, Protalix, Pharmtrace, Eudax, UCB, Phidea-Marvin, Bioikos. OCTOBER 1995 - JULY 2004 GLAXOWELLCOME SpA - GLAXOSMITHKLINE SpA. CLINICAL RESEARCH SPECIALIST ( field based )Monitoring for local and International clinical trials with regulatory ( and not ) purposes / submission ( including IND ones ). During the audits at the sites under my responsibility of monitor, no critical / major finding has ever been raised. COURSES AND CONTINUOUS TRAINING: May 1995: The principles of clinical research course ( London ) Set 1995: Modelli sperimentali nella ricerca biomedica ( ROMA ) Feb 1996: La ricerca clinica nell'industria farmaceutica ( Verona ) May 1996:Course Director on behalf of International Medical Education & Development (Athens) Sep 1996: Corso di statistica di base (Verona ) Oct 1997: Running IND studies outside of US ( Mexico City ) May 1997: Gestione delle comunicazioni per il monitoraggio delle ricerche cliniche (Firenze ) Jun 1999: Codice deontologico di Farmindustria ( Mantova ) Dec 2000: Studi di genetica - legislazione e nuovi target ( Verona ) Nov 2001: Clinical Research Refresher Course I ( London ) Nov 2008: Clinical Research Refresher Course II ( London ) SEPTEMBER 1991
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OCTOBER 1995 GLAXO SpA
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GLAXOWELLCOME SpA SALES REP EDUCATION AND TRAINING 1983
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1991 FEDERICO II UNIVERSITY, NAPOLI
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ITALY First class degree Research worker at Advanced Bio - technology sector of ENEA ( a University controlled body )   PERSONAL SKILLS Therapy area experience Therapy area National/International study Cardiovascular and relative medical device Pulmonary Metabolic disease Neurology Infectious disease Dermatology Gastroenterology Oncology Urology MOTHER TONGUE ITALIAN OTHER LANGUAGES ENGLISH
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Reading skills GOOD
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Writing skills GOOD
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Verbal skills GOOD SOCIAL SKILLS AND COMPETENCES Living and working with other people, in multicultural environments, in positions where communication is important and situations where teamwork is essential (for example culture and sports), etc. Competitive athlete of the following sports: judo, rowing and power lifting Personal Trainer ( recognized by the national federation of sports: CONI ) TECHNICAL SKILLS AND COMPETENCES With computers, specific kinds of equipment, machinery, etc. COMPETENT WITH MOST MICROSOFT PROGRAMMES DRIVING LICENCE(S) B category "

Note

"Description of all specific activities: Contribute to Project Management team activities, including co-ordination and implementation, for designated clinical trials and to monitor specified sites to ensure quality and integrity of data, compliance with relevant SOPs and regulatory requirements. Develop and maintain a full and detailed understanding of the protocol, study procedures and any other study-specific requirements for designated projects. Conduct pre-study site and initiation visits for the designated sites. Conduct monitoring visits at the sites, performing all the assigned tasks according to the project specific monitoring manual and ICH-GCP, including the check of the accuracy and completeness of the CRFs entries, source document and other trial-related records against each other. Ensure that the investigators and other study staff are aware of and comply with the study protocol, procedures and SOPs and with GCP and other regulatory requirements. Maintain regular communication with the sites, report in writing all sites visits and other contacts, ensuring that the Clinical Project Manager is informed of the study progress and/or any problems with the sites. Contribute to the in-house review of Case Report Form and to perform queries resolution, both in-house and at the sites. Conduct close-out visit at the designed sites Reports the contents, actions and recommendations of the Visits to the PM/ CRAM in compliance to the Sponsor's SOP requirements."