80 000 руб.
• Management of clinical studies (Phase II, III) and the regulatory processes governing them.
• Qualification, initiation, monitoring, and close-out site visits.
• Trial monitoring, on-sight audits, oversight, and management of clinical studies for compliance with Protocol, GCP/ICH regulations.
• trial monitoring with on-site audits of clinical data for accuracy and completeness in compliance with GCP and ICH regulations
• Clinical site and audit reviews.
2010, март — продолжаю работать, 14 лет
Clinical Research Associate II
PRA International, UK
Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH guidelines. Visits sites to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the proper conduct of studies, to review data and ensure accuracy of data collected and to terminate studies. Performs source document verification, retrieves Case Report Forms (CRFs) and performs query resolution in a timely manner and oversees drug accountability and safety at investigative sites. Ensures Serious Adverse Event (SAE) reporting according to project specifications
2008, июнь — 2010, февраль, 1 год 8 мес
Clinical Research Associate
CRO Dokumeds, Riga, Latvia
Completes project activities associated with monitoring functions of Phase III clinical research studies. GCP/ ICH and relevant regulations. Perform management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and SOPs
2007, март — 2008, апрель, 1 год 1 мес
Regional Clinical Research Associate II
Kendle International Inc, Los Angeles, CA USA
Completes project activities associated with monitoring functions of Phase II-III clinical research studies. GCP/ ICH and relevant regulations. Perform management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and SOPs and Project Specific OP (PSOPs).
2004, июнь — 2007, февраль, 2 года 8 мес
Administrator
California Rehabilitation Services, Los Angeles, CA USA
Management of regulatory processes; drafting of contracts and budgets; compliance with CMS local and federal guidelines; chairing clinical groups/ patient conference meetings and utilization review committees; development of CMS-compliant Protocols of Plan and Treatment.
2002, февраль — 2004, июнь, 2 года 4 мес
Program Director
Sherman Way ADHC, Reseda, CA USA
Individual Plans of Care Development; IPC summary drafting; chairman of multi-disciplinary team meetings and utilization review committees; audits of clinical and administrative participant charts; development and review of IPC nursing and psychosocial services, physician review of the same, supervision of group training program aides and PT/OT participants in maintenance programs, post-audit survey Plan of Corrections development.
2000, июнь — 2002, февраль, 1 год 8 мес
Assistant Program Director
Quality Time ADHC, Los Angeles, CA USA
Psychosocial assessments and reassessments; conduct of related groups; liaison for participant, medical officer, and B
1996, сентябрь — 1999, июнь, 2 года 9 мес
General Sales Manager
BITTNER GmbH ( Austria), Moscow, Russia
The development and maintenance of the distributors’ network of BITTNER brands throughout the Russia. The negotiations with major distributors during 1998-1999.
1994, июнь — 1996, сентябрь, 2 года 3 мес
Regional Sales Manager
YAMANOUCHI Europe BV ( Japan), Moscow, Russia
The development of the sales network in Ural region
1988, сентябрь — 1994, июнь, 5 лет
Staff anesthesiologist
First Moscow Medical Institute, Clinic of Faculty Surgery, Moscow, Russia
Anesthesia for abdominal and thoracic surgeries.
Курсы переподготовки
ACPE-accredited Medical Research Management Inc., San Diego, CA USA
Курсы переподготовки
First Moscow Medical Institute
Высшее образование (специалист)
Second Moscow Medical Institute
Владение языками
Английский - свободное владение
Семейное положение
Женат , Дети есть
id резюме: 6785039,
обновлено 20-05-2011 12:31:08