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SWORN/CERTIFIED LEGAL TRANSLATOR with 15-year experience
Account type
Freelance translator and/or interpreter, Verified member
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Affiliations
This person is not affiliated with any business or Blue Board record at ProZ.com.
Services
Translation, Editing/proofreading, Interpreting, Software localization, Training
English to Slovak: Clinical Trial Agreement General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English 1. SCOPE OF WORK.
1.1 Principal Investigator. The Institution shall conduct and supervise the Study through ___________________ (“Principal Investigator”). The Institution shall notify the Sponsor promptly if the Principal Investigator is unable or unwilling to continue the Study or if the Principal Investigator’s affiliation with the Institution ceases, whereupon the Sponsor will have a right of approval with respect to the designation of a new Principal Investigator.
1.2 Conduct of the Study. The Institution shall (and shall cause the Principal Investigator to) conduct the Study in accordance with this Agreement, the Protocol, all reasonable written instructions of the Sponsor, and all applicable laws and regulations, including, without limitation, any applicable requirements of the European Medicines Agency (“EMA”), United States Food and Drug Administration (“FDA”) and the International Conference on Harmonization Good Clinical Practice (“ICH GCP”) guidelines, (“Applicable Law”). The Institution shall refrain from, and shall cause the Principal Investigator and any other employee, contractor, or agent performing or assisting with the Study on behalf of the Institution (“Study Staff”) to refrain from using the Investigational Drug in any manner that is contrary to the provisions of, or outside the scope of, the Protocol or that is contrary to Sponsor’s written instructions.
1.3 Approvals. The Institution shall seek approval of the Study, the Protocol, and a written form of Informed Consent (as defined in Section 1.4) mutually acceptable to the Institution and the Sponsor, from the appropriate ethics committee(s) (the “EC”), and shall seek any other approvals required for the Study from applicable internal safety or review boards.
1.4 Informed Consent. The Institution shall obtain from each person participating in the Study (“Study Subject”) a valid informed consent (“Informed Consent”), signed by the Study Subject (unless such signature is waived by the EC) and appropriately documented. The Institution shall conduct the Study in a manner consistent with the Informed Consents.
1.5 Amendment of the Protocol. The Sponsor may amend the Protocol at any time. Any such amendment shall be in writing and sent to the Institution.
Translation - Slovak 1. ROZSAH PRÁC.
1.1 Zodpovedný skúšajúci. Inštitúcia bude vykonávať klinické skúšanie a dohliadať naň prostredníctvom ___________________ (ďalej len „zodpovedný skúšajúci“). Inštitúcia zadávateľovi bezodkladne oznámi, ak zodpovedný skúšajúci nie je schopný alebo ochotný pokračovať v klinickom skúšaní alebo ak sa skončí vzťah zodpovedného skúšajúceho s inštitúciou. Následne bude mať zadávateľ právo schváliť vymenovanie nového zodpovedného skúšajúceho.
1.2 Vykonávanie klinického skúšania. Inštitúcia bude (a zabezpečí, že zodpovedný skúšajúci bude) vykonávať klinické skúšanie v súlade s touto zmluvou, protokolom, všetkými primeranými písomnými pokynmi zadávateľa a všetkými platnými zákonmi a predpismi, a to aj vrátane všetkých platných požiadaviek Európskej agentúry pre lieky (ďalej len „EMA“), Amerického úradu pre potraviny a lieky (ďalej len „FDA“) a Zásad správnej klinickej praxe Medzinárodnej konferencie pre harmonizáciu (ďalej len „ICH GCP“), (ďalej len „platné právne predpisy“). Inštitúcia nebude, a zabezpečí, že zodpovedný skúšajúci a žiadni iní zamestnanci, dodávatelia ani zástupcovia vykonávajúci klinické skúšanie alebo pomocnú činnosť pri vykonávaní klinického skúšania v mene inštitúcie (ďalej len „personál klinického skúšania“) nebudú používať skúšaný liek spôsobom, ktorý je v rozpore s ustanoveniami tohto protokolu alebo mimo ich rozsahu, alebo v rozpore s písomnými pokynmi zadávateľa.
1.3 Povolenia. Inštitúcia sa bude usilovať o schválenie klinického skúšania, protokolu a písomného formulára informovaného súhlasu (definovaného v časti 1.4), vzájomne prijateľných pre inštitúciu a zadávateľa, od príslušnej etickej komisie, resp. komisií (ďalej len „EK“) a bude sa usilovať o ďalšie povolenia potrebné na klinické skúšanie od príslušných interných komisií pre bezpečnosť či kontrolu.
1.4 Informovaný súhlas. Inštitúcia získa od každej osoby zúčastňujúcej sa na klinickom skúšaní (ďalej len „účastník klinického skúšania“) platný informovaný súhlas (ďalej len „informovaný súhlas“) podpísaný účastníkom klinického skúšania (pokiaľ EK nerozhodne, že takýto podpis sa nevyžaduje) a riadne zdokumentovaný. Inštitúcia bude vykonávať klinické skúšanie spôsobom, ktorý je v súlade s informovaným súhlasom.
1.5 Zmena protokolu. Zadávateľ môže protokol kedykoľvek zmeniť. Každá takáto zmena musí byť písomná a musí sa zaslať inštitúcii.
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Translation education
Master's degree - University of Ss. Cyrill and Methodius, Slovakia
Experience
Years of experience: 15. Registered at ProZ.com: May 2011. Became a member: May 2011.
Credentials
English (Slovakia: Univerzita sv. Cyrila a Metoda, Filozofická fakul, verified) English (Slovakia: UCM, verified) Slovak to English (Ministry of Justice of the Slovak Republic, sworn translator, verified) English to Slovak (Ministry of Justice of the Slovak Republic, sworn translator, verified)
Memberships
N/A
Software
Adobe Acrobat, memoQ, MemSource Cloud, Microsoft Excel, Microsoft Word, Powerpoint, Trados Studio
"Gabriela is a fantastic translator. Very talented and lovely to work with. During the long project she worked on for us, she always demonstrated a positive attitude and willingness to help. Highly recommended!" (Ketty Tirrito, Comtec Translations)
AT A GLANCE
- LANGUAGES: ENGLISH, ITALIAN AND FRENCH INTO SLOVAK AND VICE VERSA
- SWORN/CERTIFIED LEGAL TRANSLATOR (English-Slovak-English)appointed by the Ministry of Justice of the Slovak Republic
- CONFERENCE AND BUSINESS INTERPRETER - consecutive and simultaneous - English-Slovak-English and Italian-Slovak-Italian
- TEACHER OF LEGAL ENGLISH - courses for attorneys and lawyers preparing them for the TOLES certificate exam, tailor-made courses of Legal English
***15 years as a professional translator***
***More than 1,500,000 words in Legal***
***More than 100 happy clients all over the world***
With the proven experience as an EU in-house translator and one of four national experts in English legal terminology at the European Commission I have been providing flawless translations from English, Italian and French into Slovak in a legal field and other fields for 15 years. Being a sworn/certified translator appointed by the Ministry of Justice of the Slovak Republic is a guarantee that you always receive accurate, terminologically correct and perfectly readable translations that save your time and money and improve your reputation.
SPECIALIZATION
LAW – contracts and agreements, court documentation, judgements, litigations, EU and national legislation, clinical trial agreements and clinical trial documentation etc.
EUROPEAN UNION DOCUMENTS – regulations, directives, decisions, communications, annual reports, press releases, website content etc.
COMPANY DOCUMENTATION – Memorandum and Articles of Association, company policies, handbooks, Code of Conduct, annual reports, trainings, extracts from the Register of Companies
LEGAL WEBSITE CONTENT – GDPR related texts, Privacy Policy, Terms and Conditions, Terms of Use, Return Policy, Imprint, legislation
OFFICIAL DOCUMENTS – ID cards and passports, birth certificates, marriage certificates, diplomas, criminal record extracts, work permits, residence permits
MARKETING AND LOCALIZATION – translation and localization of websites, translation of all kinds of marketing materials including product descriptions, marketing campaigns etc.
STUDIES AND TRAININGS
- Master’s Degree in English Language and Literature at the Philosophical Faculty of the University of Ss. Cyril and Methodius in Trnava, Slovakia
- Trainings at the European Commission: Fundamentals of Law, Pharmaceutical Terminology, Economy and Economics, IT trainings (Trados), Multicultural Communication, language trainings (Italian courses, French courses), proofreading training
- Legal training preparing for the examination to become a sworn translator, Presov University, Slovakia
PROFESSIONAL EXPERIENCE
Freelance translator, interpreter and teacher of Legal English (since 2011)
Linguistic consultant of the former Italian Vice-Minister of Labour in the field of the English labour law terminology (since 2018)
In-house full-time translator at the European Commission in Luxembourg (3 years)
National expert in English legal terminology (translator) at the European Commission in Luxembourg (2 years)
Teacher of English legal terminology at the Law Faculty of Trnava University in Trnava, Slovakia (2 years)
Translator at the News Agency of the Slovak Republic in Bratislava, Slovakia (3 years)
Business interpreter English-Slovak-English for Techo, a.s., Slovakia (1 year)
MAIN PROJECTS
- translation and revision of European Union regulations, directives, decisions, communications, press releases, website content, speeches of commissioners, ISO norms, UN ECE regulations, international contracts and other documents for various DGs of the European Commission
- various documents for other EU bodies and agencies including the European Parliament and European Data Protection Officer
- judgements of UK and Slovak courts and other court documentation
- official documents (birth certificates, marriage certificates, passports, etc.)
- childcare documentation for UK social services
- contracts for various companies
- legal website content - Terms and Conditions, Privacy Policy
- GDPR-related texts for various companies
- Articles of Association, extracts from business registers
- various training materials for private companies
- development of Slovak language tests for European Personnel Selection Office (EPSO)
- interpreting for private companies and international conferences
- giving courses of Legal English to lawyers and attorneys in Rome including the former Italian vice-minister of labour
- preparing clients for the TOLES - international certificate in Legal English
- description of medicinal products (Summary of Product Characteristics + Patient Information Leaflet) for the European Medicine Agency
- clinical trials - patient questionnaires, instructions for various tests, clinical trial contracts etc.
- various public opinion questionnaires including Eurobarometer questionnaires and questionnaires for Google
- hotel descriptions and marketing material for Booking.com and other leaders in the travel industry
- marketing campaigns and cosmetic products for the most famous cosmetic brands
TRANSLATION SOFTWARE
SDL Trados Studio 2019
Memsource
MemoQ
CateMat
Stream
CONTACT
gsimonova@gmail.com
I provide my CV and reference letters on request.
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Member since May '11
Expertise