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Candidate

Female, 42 years, born on 16 January 1983

Not looking for a job

Dzerzhinsky (Moscow region), not willing to relocate, prepared for business trips

The approximate area of the job search is specified

Regulatory Specialist

80 000  in hand

Specializations:
  • Sales manager, account manager

Employment: full time

Work schedule: full day

Work experience 12 years 5 months

December 2018December 2019
1 year 1 month
1000 beans. Language school

Japan

English teacher
Group and privet English classes.
May 2016January 2018
1 year 9 months
Historical event agency “Ratobortcy”

Russia

CEO personal assistant
Conducting and participation at business meetings, negotiations and VIP presence at agency’s festivals. Recordation the meetings. Business correspondence both English and Russian languages. Preparation analytical data. Check of CEOs errands. Travel support. Accomplishment of private requests.
January 2014May 2016
2 years 5 months
INC Research

Moscow

Regulatory Specialist I
1. Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials. 2. Responsible for providing delivery and expertise in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, import/ export licenses, review and finalization of essential documents required for site initiation. 3. Ensures local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards. Ensures an efficient start-up process on assigned studies. May act as main contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs). 4. Under the direction of the Project Manager (PM) or Site Start-up Lead (SSUL) as appropriate, may directly interact with Customers regarding requirements from RA or other local regulatory party. 5. Accountable to the PM/SSUL at the project level and line manager for deliverables.
August 2012December 2013
1 year 5 months

Moscow

Regulatory specialist 1
1. Primary contact with investigative sites during site start-up activities. 2. Responsible for working with investigative sites to collect the required investigator and regulatory documents for a study and ensuring that the documents meet the specifications required by local regulations, EU Clinical Trial Directive, ICH-GCP, FDA regulations (for IND studies) and/or the study sponsor. 3. Collect, review, approve process and track regulatory & investigator documents required for study site activation. 4. Review and approve core English patient informed consents for compliance to international requirements and protocol as applicable. 5. Review and approve core Country patient informed consents for compliance to country requirements and protocol as applicable. 6. Review and approve investigative site specific patient informed consents for required elements. 7. Resolve informed consent and contractual language issues by exercising advanced judgment when interacting with study sites. 8. Prepare new investigator submission packages to Local and/toCentral IRB /IEC. 9. Submission the trials to the MoH and LECs.
September 2011August 2012
1 year
East Site Management And Research, Ltd

Moscow

Clinical Trial Administrator
1. Assist with the Ethics / Regulatory Submissions; keep a track of submissions & approvals for the study. 2. Set up and maintenance of the Trial Master Files (TMF) or Electronic filing systems/ set up of the Investigator Site File (ISF). 3. Managing and maintaining study documents & trial supplies e.g.; Patient Information Sheets, Patient Diaries, Lab Kits & Medical equipment for sites. 4. Preparing essential clinical trial documentation, distributing, tracking and filing of documents on return. 5. Sending out Study Newsletters / Study Correspondence to all participating sites on an ongoing basis. 6. Processing SUSAR (Adverse Events) notifications in a timely manner. 7. Arranging translation of patient documents. 8. Assisting Clinical Research Associates on monitoring visits. 9. Ensure that any clinical trial databases/ tracking tools are set up and maintained throughout the trial. 10. Re-ordering clinical drug supplies for sites. Sep 2010 – Aug 2011 Trial Administrator Assistant 1. Assistance to Clinical Research Coordinator in informing and maintain of trial master file in the office. 2. Sending to sites and receipt of complete feasibility questionnaires. 3. Receipt of DCR from Sponsor, sending them to sites, contact with sites and control of getting answers on DCR from sites. 4. Organization of sending off study drug and materials from depot, preparation of the appropriate documentation. 5. Review of correspondence of the company for all projects; in case of absence of Clinical Research Coordinator to be in correspondence with Sponsor after concurrence of Clinical Research Coordinator (or Director of the company in case of absence of Clinical Research Coordinator in resolving of serious questions) in order to solve the appearing questions. 6. Assistance to Clinical Research Coordinator in receipt of necessary documents from sites (including source documents related to AE/SAE, resolved queries). 7. Maintenance of tracking of SAE: receipt of SAE report from Clinical Research Coordinator, control of terms of their submission to Sponsor, Pharmacological Center / Ethics Committee, sites; archiving of them in trial master file in the company office; scanning of reports and source documents for SAE and sending of them to Sponsor. 8. Interaction with Financial Department of Sponsor – communication regarding payments to Investigators and subcontractors (Central Laboratory, Brokerage Company, etc.), any discrepancies between invoices and payment orders and etc.
February 2010August 2010
7 months
Closed Join Stock Company «Cytron», net of boutiques «Podium»

Moscow

Shop-assistant
Assistant to the customers with their shopping.
July 2009January 2010
7 months
"Copir-club" LTD

Moscow

Office manager
1. Flow of documents in organisation. 2. Office-work. 3. Planning courier's day. 4. Organisation of Director's business trips. 6. Arranging meetings. 7. Maintains office staff by recruiting, selecting, orienting, and training employees.
November 2008April 2009
6 months
WWF

Moscow

Head of Secretariat
Main responsibilities: 1. Working under the standard operating procedures. 2. Timely providing with incoming and outcoming correspondence. 3. Organization and maintenance of the Secretary department, recruiting of the new employees. 4. Maintenance of the courier work. 5. Providing the marketing analysis and preparation of new supplied companies. 6. Assisting to Heads of WWF. 8. Passport and visa supplying for found employee. Collaboration with consular department of the Ministry of Foreign Affears. In submission: three secretary and courier
September 2006November 2008
2 years 3 months
Media company SCHIBSTED, net of newspapers «Moi Raion»

Moscow

Office manager, office administrator, sales director assistant
2008 – office-manager. Main responsibilities: 1. The organization of administrative work. 2. Working with the constituent documents, and other legally-relevant documents of the company. 3. Cooperation with the accounting department in charge of registration of the current tangible assets of the Moscow branch of the company. 4. Negotiating, contracting and implementation of ongoing work with the landlord, telecommunications and insurance companies (working with CBOs and property insurance company). 5. Arranging and control the work of the office administrators and couriers. 6. Provide ongoing maintenance of technical equipment and premises of the company. 7. Purchases of goods, services and works to ensure the smooth operation of the office. The control exhibited for payment of invoices for goods supplied, services and activities. 8. Control of cleaning and maintenance of the premises of the company. Since April 2008, in connection with the departure of manager for administrative and personnel issues in maternity leave, the duties: 1. Collection of documents for registration of employees under labor contract, the registration of the data for the human resources department. Registration of civil contracts for freelancers. 2. Registration of foreign employees to work. 3. Preparation of necessary documents from the workplace for employees at their request. 4. Making of business trips and reports on business trips. 5. Preparation of documents for payment of suppliers accounting. Signing and approval of contracts with suppliers / contractors. 6. Tracking of payments. 7. Collection of original documents for the reporting of the Moscow office. 8. Provision of data for interpretation, and advance employees' salaries. 9. Registration of orders for hospitality organizations. In submission, two administrative offices, three courier, cleaner, system administrator and the assistant. 2007 – 2008 – office administrator. Main responsibilities: 1. The conduct of negotiations by telephone. 2. Registration of all incoming and outgoing documents. 3. Drafting of business letters, draft administrative documents, taking minutes of meetings. 4. Booking rooms in hotels, air and railway tickets, insurance, etc. 5. Regulating the flow of visitors. 2006 - 2007 гг. – commercial department assistant 1. Implementation of the collection of materials and information required by the Ssales Director, preparation of analytical, informational, reference and other materials and present them to the head. 2. In the absence of the financial manager: а) maintaining a table of shipping managers / clients and report "content advertising № №» for managers. b) Monthly assistance for the preparation of closing documents to be sent to customers. 3. Entering in the CRM (customer database) transactions and sales managers working outside the office. 4. Document Management at the department
January 2005January 2006
1 year 1 month
SCHIBSTED

Saint Petersburg

Journalist/copywriter
Creating advertising texts, headlines, articles and slogans for both clients and personal needs of the commercial service.

Skills

Skill proficiency levels
Английский язык
Organization Skills
Written Translation
Управление проектами
Деловая переписка
Деловое общение
Работа в команде

About me

Microsoft Office, Clinical Trials, maintenance of technical equipment and premises, Standard Operating Procedure, Monthly assistance, Microsoft Word, Microsoft PowerPoint, Microsoft Outlook, Microsoft Excel, Internet explorer,

Portfolio

Higher education

2013
Moscow State Linguistic University
Teaching the English language
2011
Britanian Educational Center
English language
2006
Saint-Peterburg State Agrarian University
Museum affairs
2004
VKS school
English language

Languages

RussianNative


EnglishC1 — Advanced


Professional development, courses

2018
Smart &Talented Personal assistant
Cources, Smart business assistant
2018
Moscow State University
Education, Russian like foreign language
2017
Japanese language school
Foreign languages, Japanese language course

Citizenship, travel time to work

Citizenship: Russia

Permission to work: Russia

Desired travel time to work: Doesn't matter