Контактна інформація

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Освіта

National Technical University of Ukraine 'Kyiv Polytechnic Institute'

Biotechnology, Kiev
Вища, з 1995 по 2001 (5 років 6 місяців)

Додаткова освіта та сертифікати

NIH on-line GCP training

6-hours

Знання і навички

Знання мов

Англійська — просунутий

Додаткова інформація

Sergey Krasyuk
Clinical Research Associate

Tel: [відкрити контакти](див. вище в блоці «контактна інформація»)
E-mail: [відкрити контакти](див. вище в блоці «контактна інформація»)
Skype: krasser1978
[відкрити контакти](див. вище в блоці «контактна інформація»)

EDUCATION
National Technical University of Ukraine “Kyiv Polytechnic Institute” (NTUU “KPI”)1995-2001
Master’s degree in Biotechnology

PROFESSIONAL EXPERIENCE

bioRASI LLC, Kyiv, Ukraine May 2013 – now
Associate, Clinical

CURRENT RESPONSIBILITIES:
•UPDATED GCP CERTIFICATE VALID UNTIL 16 AUG 2017
•To be fully aware of the Sponsor’s Study requirements.
•To ensure selected study sites are having adequate qualification, resources and facilities/equipment and can provide adequate eligible subjects, the investigators are of adequate qualifications.
•Business Development Associate: looking for potential sites for Sponsors’ CT projects Phase I-IV, BE studies in Ukraine. Price and enrollment rate assessment according to study Synopsis, negotiations with potential PI’s.
•Collected and prepared documents for RA initial submission according to MoH local regulations.
•Perform all types of site visits including Site Selection, Initiation, Monitoring, and Close-out. Perform drug accountability and other monitor activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols.
•To ensure that IRB/Ethics Committees submissions have been timely conducted and approvals received.
•Liaison with Local Depot to ensure labkits and drug storage and shipment.
•Selection of vendors for CT purposes (translations, local depot, all-Ukrainian taxi service for CRAs, Investigators and patients).
•To be a first-line contact with Clinical Sites and report to the trial Manager all major site related issues in an expedited manner.
•AE/SAE/AESI expertise; to undertaking all efforts the safety and well-being of trial subject are fully protected.
•To ensure that Investigators are fully briefed on the study.
•Discuss the study requirements with the Investigators at the Investigators’ meeting, reinforcing information provided in format presentation.
•Ensure that Investigator receive all study documents and any updates of them.
•Motivate investigator and site staff, providing ongoing study training.
•Perform source documents verification, retrieve Case Report Forms (CRFs) and performed query resolution in a timely manner.
•To follow with appropriate filing of documents in Investigator Site File and In-house Investigator Site File.
•Function as mentor and role model for other CRA team members to ensure study specific training for CRAs; Perform co-monitoring visits with less experienced CRAs and at problem sites as required.
•Performed site facilities inspection
•Medical writing (IB, ICF) according to ICH GCP regulations.

FIRST MEDICAL Co., Kyiv, Ukraine, Apr 2011 – May 2013
Director, Chief Editor
CRA (all activities).

Responsibilities:
General Financial and Administrative Management of the First Medical company LLC.
Monitored clinical studies according to Sponsor’s requirements and ICH Guidelines.
Preparing documentation for necessary approvals, observing feasibility, recruitment, performing monitoring at sites, reporting visits and contacts with site, assuring the presence of all relevant documents on site, collaborating with other departments for reporting safety information, collecting Case Report Forms, following up and solving data queries, reporting the progress of the study on a regular basis.
Responsible for obtaining of appropriate documentation from sites.
Conducted monitor training for new Clinical Research Associates.
Performed electronic database quality control maintenance.
Conducted protocol training at Investigator sites.
Performed close-out visits.
Provided clinical study tracking and performance metrics.
Provided in-house support for the CRAs during their site visits.
Proofreading and interpretation of the texts of various areas of knowledge (predominantly medicine, chemistry, biotechnology, Life Sciences, laboratory and medical devices)
Feasibility management of the sites for potential clinical trials in Ukraine and Russia.
Regulatory activities (as a team member) for the MoH and LECs submission of new MS study in Ukraine.
Managing the translators’ team. QA management.

FREELANCE TRANSLATOR - 2008 – 2011
Medical, pharmaceutical and technical En-Ru, Ukr translations including patents.
...

PC Skills
MS Office, Acrobat, mail clients, EDC, IWRS

AREAS OF THERAPEUTIC MONITORING EXPERIENCE
CNS, immunology, oncology, infectious diseases.