Контактная информация

Соискатель указал телефон, эл. почту и адрес.

Получить контакты этого кандидата можно на странице https://www.work.ua/resumes/3452065

Опыт работы

Sr.CRA

с 10.2016 по наст. время (7 лет 7 месяцев)
Arabian Gulf University Clinical Research Centre, Bahrain (Clinical Research)

Site selection, preparation for site Initiation Visits. Site Initiation. Full monitoring responsibilities. Site Monitoring Visits and all relevant activities, study files maintenance, study-specific site staff training, revelation and escalation of quality issues, management of regular and timely submission of the site monitoring visit reports and other required documents. Appropriate update of all relevant systems.

SrCRA

с 04.2011 по 09.2016 (5 лет 5 месяцев)
Quintiles, Киев (Clinical Research)

Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas. • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation. • Act as a mentor for clinical staff including conducting co-monitoring and training visits. • May provide assistance to the CTL with design of study tools, documents and processes. Perform Lead activities on responsible protocol.

Образование

НМУ им.Богомольца

1- лечебный, Киев
Высшее, с 2000 по 2006 (6 лет)

Знание языков

Английский — продвинутый