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54 года, мужчина

Москва

Гражданство: Россия

Желаемая должность и зарплата
Clinical Research Associate
80 000 руб.
График, место работы
Ищу работу в городе: Москва . Командировки возможны.
Стаж в желаемой должности
4 года
Профессиональные навыки
All aspects of research stemming from prior experience as a medical doctor, clinical research associate, clinical trials manager and program director.
• 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.
Основное образование
Высшее , Second Moscow Medical Institute , 1986
 
Опыт работы

2010, март — продолжаю работать, 7 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.

 
Основное образование
1986 г.в.

Высшее образование (специалист)

Second Moscow Medical Institute

medicine
 
Дополнительное образование

2007 г.в.

Курсы, повышение квалификации

ACPE-accredited Medical Research Management Inc., San Diego, CA USA

Clinical Research Associate Education and Training Program, Certified Clinical Research Professional

 

1988 г.в.

First Moscow Medical Institute

Residency in anesthesiology and intensive care., Anesthesiologist

 

Владение языками

Английский - свободное владение

 
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Семейное положение

Женат , Дети есть