Специалист по мониторингу клинических исследований/Руководитель проектов КИ

Описание


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Languages

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Curriculum vitae
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Tatiana Koroleva
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PERSONAL DETAILSDate of Birth: 28 February 1987, 35 years
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Moscow, m. VDNKH / Ivanteevka, Moscow region Tel: +7 (915) 244 04 66, Email: salnikova.tanya@gmail.com
CURRENT POSITIONClinical Research Project Manager


Russian; English - Pre-Intermediate level

Education




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2008-2010:

2004-2008:


Work experience

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D.I. Mendeleev University of Chemical Technology of Russia, Medical polymers, Biotechnology /Masters degree
D.I. Mendeleev University of Chemical Technology of Russia, Biotechnology/ Bachelor's degree


Dec 2021 - till present


LLC "Independent Laboratory INVITRO", Moscow, Russia
Clinical Research Unit
Position: Clinical Research Project Manager

Organization of clinical trials and in vitro studies of company's

Preparation of commercial proposals, coordination of the terms of the study with the customer;

Processing requests for clinical trials of medicines, patient support programs, retrospective studies;

Managing clinical trials according to GCP and other applicable standards

Preparation, approval and conclusion of contracts with sponsoring companies;
Preparation and timely submission of a complete package of research documents to the regulatory authorities of the Russian Federation;

Cooperation with R&D functions and other departments
Prospecting for new clinical and in vitro research sites.
Develop and optimize business processes, prepare related documentation.

Planned, managed and implemented a start-up project
Management of patient support programs
Participated in advertisement design and placement.

Maintaining/leveraging relationships with Regulatory Agencies, Pharma Organizations and influence external environment as appropriate.

Representing Clinical Operations department at the affiliate; liaising with affiliate personnel for alignment, strategy and others when applicable.

Search for scientific data, orders and other information necessary for conducting a clinical trial.

Sep 2020 - Dec 2021































Feb 2020 - Sep 2020



Jul 2014 - Feb 2020

LLC "ClinPharmDevelopment", Yaroslavl, Russia
Position: Clinical Research Associate
Assess potential investigators and decide on the suitability of the site.
Develop/adapt recruitment and retention strategy for the site.
Ensure that the current versions of the trial documents that are listed on the Site Initiation Report and all required trial-related materials and supplies are provided to the investigational site.
Negotiate investigator budgets at site level and track the status of site CTA.
Plan and conduct investigator and site-staff training.
Conduct site initiation, monitoring and closure visits.
Create site specific and monitoring tools.
At the investigational site, ensure clinical drug supplies are available, appropriately used, handled, stored (e g, temperature logs, security), and returned, accurately inventoried and documented
To maintain awareness of local regulatory requirements, and to conduct studies in accordance with SOPs, guidelines and ICH Good Clinical Practice guidelines
Assistance in feasibility studies
Communication with investigational sites
Participation in national/international project and investigational meetings.

LLC "BRINGER", Moscow, Russia
Position: Clinical Research Associate( contract)
Preparation SOPs and forms for company.

LLC "ATLANT CLINICAL", Moscow, Russia
Position: Clinical Research Associate Assistant, Junior Clinical Research Associate, Clinical Research Associate, Senior Clinical Trial Coordinator
Assess potential investigators and decide on the suitability of the site.
Develop/adapt recruitment and retention strategy for the site.
Ensure that the current versions of the trial documents that are listed on the Site Initiation Report and all required trial-related materials and supplies are provided to the investigational site.
Negotiate investigator budgets at site level and track the status of site CTA.
Plan and conduct investigator and site-staff training.
Conduct site initiation, monitoring and closure visits.
Create site specific and monitoring tools.
At the investigational site, ensure clinical drug supplies are available, appropriately used, handled, stored (e g, temperature logs, security), and returned, accurately inventoried and documented
To maintain awareness of local regulatory requirements, and to conduct studies in accordance with SOPs, guidelines and ICH Good Clinical Practice guidelines
Assistance in feasibility studies
Communication with investigational sites
Participation in national/international project and investigational meetings


Mar 2010 - Jul 2014


























Oct 2009 - Nov 2010


LLC "PROMINVEST", Moscow, Russia
Position: Personal Assistant
Administrative support: creating, editing or printing documents on an as needed basis, managing paperwork related to business trips arrangement, payments processing, system support and other such things;Help to organize business travel: book tickets, prepare internal travel requests, book hotels, visas support.Working with various documents: copying, filing, mailing.Draft presentations.Translations (written) to the supervisor and in general as requested;Manage day-to-day processes related to office management as needed to the supervisor, coordination of related matters and drawing attention to issues of concern, ordering stationary, managing vacation lists etc.
Be a point of contact for external departments in providing information regarding schedule and availability of supervisor, manage calendar if required.
Provide support for supervisor's meetings, minutes keeping.
Driver management
Work on individual tasks as set by the supervisor.
Complete all tasks accurately and on-time.

Federal State Unitary Enterprise State Research Center"NIOPIK", Moscow, Russia
Position: Clinical Research Associate
















Relevant training

2022


2021


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2018


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2015


2015



2014

2014


2014


2010
Provide clinical support for projects according to Standard Operating Procedures, ICH Guidelines and GCPAct as contact for project team and study sites
Assist with the management of study supplies and organize shipments
Create, update, track, and maintain study-specific trial management files, tools, and systems
Ensure compliance with SOPs, ICH, and GCP regulations for clinical conduct in all aspects of daily work
Assist in submissions and notifications to Ethics Committees and Regulatory Authorities




Certificate of ICH GCP Course, Statandocs

Training