Специалист по клиническим исследованиям (CRA)

Описание

CURRICULUM VITAE

First Name, Middle name, Surname Natalya N.Tkachenko
Work Address, Tel., Email MatrixPharm, OOO
Nauchny pr., 8, bl. 1, Moscow, Russia, 117246
Mob. +7-922-16-16-239,
Natalya.tkachenko@matrixpharm.com


Current Position
Since Positions Department
14.10.2008 Clinical Research Association Clinical Research
Responsibilities Monitoring
Type of employment full-time part-time contract


Relevant Previous / Other Employment
Dates Position, Organization, City, Country
Mar2007-Oct2008 Interpreter, Free-lance. Ekaterinburg, Russia


University and Post-Graduate Education
Years University / Training course, City, Country Qualification / specialization
1997-2002 Ural State University, Psychology, Ekaterinburg, Russia Psychologist, Psychology lecturer.
2005-2007 Ural State University, Foreing languages, Interpreter in the field of professional
Ekaterinburg, Russia communications


Training Courses and Seminars
Month, Year Name of the course Organizer, City, Country
29th -30th Jan 2009 General Principles of ICH GCP for Matrix Pharm, Ekaterinburg, Russia
Investigators
04th Feb2009 RDE, SBIR «Certified Trainer», GSK, Moscow, Russia
GSK SOPs.
11th-13th Aug 2009 GSK Advanced Monitoring Course Training & Quality Risk Management, Moscow, Russia
30 th Aug 2012 «Conducting Quality Monitoring Activities» Refresher GSK BIO: Saint Petersburg, Russia
for Clinical Operations Team in Russia
Oct 2013 – May 2015 GSK SOPs, training modules My Learning System GSK, trainings are passed on regular basis
March, 2017 ICH-GCP MatrixPharm”, Moscow, Russia
March, 2019 ICH-GCP MatrixPharm”, Moscow, Russia


Clinical Trials Experience
Short description Therapeutic area Phase Function Time
FLU–NG, Vaccine III CRA Sep2008 – Jul2010
Flu vaccine for elderly subjects
Comparative trial, combined chemotherapy for Hematology III CRA Nov2010 – Jan2012
subjects with multiple myeloma
Comparative trial, inhalation solution for COPD Pulmonology IV CRA Apr2012 –Apr2013
subjects
Comparative trial, postoperative analgesia Anesthesiology III CRA Jan2012 – Jul2014
Comparative trial, phosphor excesses therapy for Nephrology III CRA Mar2012 – Jun2014
renal dialysis subjects
Comparative trial, for Asthma subjects Pulmonology III CRA Apr2012 – Jul2013
Comparative trial, for Asthma subjects Pulmonology III CRA Sep2012 - Sep2013
A multi-centre, open-label, long term safety Pulmonology IV CRA Dec2012 – present time
study in asthmatic subjects.
Comparative trial, immunostimulative drug with General practice IV CRA Dec2012 – Nov2013
baseline therapy
Comparative trial, for Asthma subjects Pulmonology III CRA Jan2013 – Dec2014
Comparative trial, Oral contraceptive Ginecology III CRA Dec2013 – Nov2014
Randomized, Double-Blind, Parallel-Group, Pulmonology III CRA Sep2014 – Apr2015
Placebo-Controlled Study to Evaluate the Efficacy
of IP, for COPD subjects
A Randomized, Blinded, Double-dummy, Pulmonology III CRA Oct2014 – Mar2017
Parallel-group Study to Evaluate the Efficacy and
Safety of IP, for COPD subjects
Randomized, Double-Blind study of combination of 2Oncology III CRA Jul2014 – Sep2017
IPs vers. 2 placebos, for subjects of high-risk
BRAF V 600 mutation-positive melanoma
Comparative trial, sinthetic gonadotrophin Ginecology III CRA Apr 2016 - Mar2019
analogue, endometriosis
SUSTAINABILITY OF EFFICIENCY AND LONG-TERM SAFETY HIV-infection IV CRA Nov2019 – present time
PROFILE OF DOLUTEGRAVIR-CONTAINING REGIMES
(non-interventional study)


Language Proficiency
native excellent very good rather good a little
Spoken Russian
Written
Spoken English
Written English


Computer Literacy
Operating Systems
Software yes
Network yes


Date (dd.mm.yyyy) 22 Nov 2022 Signature