Переводчик медицинской литературы

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Curric u lu m v it a e


Koro le va V ero nik a

Dze rz h in sky, M osco w r e gio n

+7916 -1 5 1-0 1-4 5

ko ro le va vv1 983@ gm ail. c o m


Pers o nal in fo rm atio n:

Date o f b ir th – 1 6th o f J a nuary 1 983

Fam ily – s in g le


Main e d ucatio n:

2011 – 2 013 – M osco w S ta te L in gu is tic U niv e rs it y . F acu lt y o f

th eory a nd m eth ods o f te ach in g fo re ig n la nguages

2003 – 2 006 – S ain t- P ete rs b urg S ta te A gra ria n U niv e rs it y .

Facu lt y o f m use um m ana gem ent

2000 – 2 003 – In te rn atio na l U niv e rs it y o f n atu re , s o cie ty a nd h um an “ D ubna”. F acu lt y o f

jo urn alis m


Addit io nal e d ucatio n:

2019 – J a panese la nguage c o urs e , T okyo

2017 – In te nsiv e c o urs e fo r th e B usin e ss a ssis ta nts , M osco w

2010 – 2 011 – E nglis h la ng uage c o urs e in B rit is h E du ca tio nal C ente r, M osco w

2008 – S tu dy c e ntr e “ B usin e ss-A sp ect” , s e m in ars “ O ffic e w ork a nd o rg aniz a tio n o f

docu m ents p ro ce dure s”, “ M odern o ffic e m an ager. R esp onsib ilit ie s a nd b usin ess e tiq uette ”,

Mosco w

2005 – E nglis h la nguage c o urs e , M alt a

2004 – S um mer E nglis h c o u rs e in V KS s ch ool, M osco w


Jo b E xp erie n ce:

Jan uary
​ –
​Decem ber 2 0 19
​ –
​ “1 0 00 B ea n ” T oky o E ng li s h s ch o ol.

Englis h te ach er


May 2 016
​ –
​Novem ber 2 01 8
​ –
​His to ric a l e v en t a g en cy “ R ato bortc y”. M osco w , R ussia .

CEO p ers o nal a ssis ta n t.

● Conductin g a nd p artic ip atio n a t b usin e ss m ee tin gs, n egotia tio ns a nd V IP p re se nce a t

agency’s fe stiv a ls

● Reco rd atio n th e m ee tin gs

● Busin ess c o rre sp o nde nce b oth E ngli s h a nd R ussia n la nguages

● Pre para tio n o f a na ly tic a l d ata

● Check o f C EO s e rra nds

● Tra ve l s u pport

● The a cco m plis h m ent o f p riv a te r e qu ests


Jan 2 014 – M ay 2 016 IN C R esea rc h , M osco w , R ussia .

Sit e S ta rt-U p & R eg ula to ry S pecia lis t I.

● Perfo rm s a ssig ne d a ctiv it ie s w it h in th e c o u ntr y th at le ad to th e s ta rt- u p o f

in ve stig ativ e s it e s in a ll p hase s o f c li n ic a l tr ia ls

● Resp onsib le fo r p ro vid in g d eliv e ry a nd e xp e rtis e in o ne o r m ore o f th e fo llo w in g

fu nctio nal a re as: e th ic s a nd r e gula to ry s u b m is sio ns, r e vie w a nd fin aliz a tio n o f

esse ntia l d ocu m ents r e quir e d fo r s it e in it ia tio n

● Ensu re s lo ca l a ctiv it ie s a re u n derta ke n b y a gre e d tim elin es, a llo ca te d b udgets , a nd

re quir e d q ualit y s ta ndard s. P ro vid e s a n e ffic ie nt s ta rt- u p p ro ce ss o n a ssig ned

stu die s. M ay a ct a s th e p rim ary c o n ta ct w it h R egula to ry A uth orit ie s ( R A) a nd

Centr a l/ R egio nal E th ic s C om mit te es ( E C s)

● Under th e d ir e ctio n o f th e P ro je ct M ana ger ( P M ) o r S it e S ta rt- u p L ead ( S SU L) a s

appro pria te , m ay d ir e ctly in te ra ct w it h C usto m ers r e g ard in g r e q uir e m ents fr o m R A o r

anoth er lo ca l r e gu la to ry p arty

● Acco unta ble to th e P M /S S U L a t th e p ro je ct le ve l a nd lin e m an ager fo r d eliv e ra ble s


Sin ce S ep 2 015 d ue t o t r a n sit io n t o t h e d ep artm en t ( C en tr a l H ub), s u pportin g t h e

stu die s o n m ain te n an ce p hases, f u lf ilm en t t h e r o le a s t h e R eg ula to ry L ead w it h t h e

fo llo w in g r e sp onsib ilit ie s:

● Managin g a nd o ve rs e e in g r e gula to ry a ctiv it ie s p re d om in antly w it h in th e m ain te nance

phase o f s tu die s in d if fe re nt c o untr ie s s u ch a s s u bsta ntia l a m en dm en ts

adm in is tr a tiv e c h an ges, A nn ual P ro g re ss R eports ( A PR ) a nnual IB u pdate s; E nd o f

Tria l ( E oT ) n otif ic a tio ns, C SR s u b m is sio ns a s w ell a s o th er a pplic a ble n otif ic a tio ns

● The H UB a ls o p la ys a n in te gra l p art o f th e s it e s ta rt- u p ( S S U ) b y m an agin g th e IP

re le ase p ro ce ss a n d e nsu rin g t h a t a ll e sse ntia l d ocu m en ts ( E D s) a re in p la ce

pro m ptly

● Сom munic a tin g w it h th e p ro je ct te am s to e nsu re th at th e s p onso r is p ro vid ed w it h

re gula r, c le ar, c o ncis e u pd ate s o n r e gula to ry a ctiv it ie s a nd e nsu rin g th at w e a dhere

to tim elin es w it h a n y r is ks h ig hlig hte d


Aug 2 012 - D ec 2 013 C ovan ce, M osco w , R ussia .

Glo bal S it e s erv ic es s p ecia lis t.

● Prim ary c o nta ct w it h in ve stig ativ e s it e s d urin g s it e s ta rt- u p a ctiv it ie s

● Resp onsib le fo r w ork in g w it h in ve stig ativ e s it e s to c o lle ct th e r e q uir e d in ve stig ato r

and r e gula to ry d ocu m ents f o r a s tu dy a nd e nsu rin g th at th e m ate ria ls m eet th e

sp ecif ic a tio ns r e q uir e d b y lo ca l r e gula tio ns, E U C lin ic a l T ria l D ir e ctiv e , IC H-G CP,

FD A r e gula tio ns ( fo r IN D s tu die s) a n d/o r th e s tu dy s p onso r

● Colle ct, r e vie w , a pp ro ve p ro ce ss a nd tr a ck r e g ula to ry & in ve stig ato r d ocu m en ts

re quir e d fo r s tu dy s it e a ctiv a tio n

● Revie w a nd a ppro ve c o re E nglis h , a nd C ountr y p atie nt in fo rm ed c o nse nts fo r

co m plia nce w it h in te rn atio nal r e quir e m ents a nd p ro to co l a s a pplic a ble a nd p er th e

re gula tio ns

● Revie w a nd a ppro ve in ve stig ativ e s it e -s p ecif ic p atie nt in fo rm ed c o nse nts fo r r e quir e d

ele m ents

● Pre pare n ew in ve stig a to r s u bm is sio n p acka g es to L oca l a nd to th e C entr a l IR B /IE C ;

● Subm is sio n th e tr ia ls to t h e M oH a n d L E C s

Sep 2 011 – A ug 2 012 “ E ast S it e M an ag em en t A nd R esearc h ” L td .

Clin ic al T ria l A dm in is tr a to r.

● Assis t w it h th e E th ic s / R egula to ry S ubm is sio ns; k e ep tr a ck o f s u bm is sio ns &

appro va ls fo r th e s tu dy

● Setu p a nd m ain te na nce o f th e T ria l M aste r F ile s ( T M F) o r E le ctr o nic filin g s yste m s/

se t u p o f th e In ve stig ato r S it e F il e ( IS F)

● Managin g a nd m ain ta in in g s tu d y d ocu m ents & tr ia l s u pplie s, e .g ., P atie nt In fo rm atio n

Sheets , P atie nt D ia rie s, L a b K it s & M edic a l e quip m en t fo r s it e s

● Pre parin g e sse ntia l c lin ic a l tr ia l d ocu m enta tio n, d is tr ib utin g, tr a ckin g a nd filin g o f

docu m ents o n r e tu rn

● Sendin g o ut S tu dy N ew sle tte rs / S tu dy C orre sp ondence to a ll p artic ip atin g s it e s o n

an o ngoin g b asis

● Pro ce ssin g S U SAR ( A dve rs e E ve nts ) n otif ic a tio ns o n tim e

● Arra ngin g tr a nsla tio n o f p atie n t d o cu m ents

● Assis tin g C lin ic a l R ese arc h A sso cia te s o n m on it o rin g v is it s

● Ensu re th at a ny c li n ic a l t r ia l d a ta base s/ tr a ckin g to ols a re s e t u p a nd m ain ta in ed

th ro ughout th e tr ia l

● Re-o rd erin g c lin ic a l d ru g s u p plie s f o r s it e s


2010 – 2 011 - T ria l A dm in is tr a to r A ss is ta n t.

● Assis ta nce to C lin ic a l R ese arc h C oord in a to r in in fo rm in g a nd m ain ta in o f th e tr ia l

maste r file in th e o ffic e

● Revie w o f c o rre sp on dence o f th e c o m pan y fo r a ll p ro je cts

● Assis ta nce to C lin ic a l R ese arc h C oord in a to r in r e ce ip t o f n ece ssa ry d ocu m en ts fr o m

sit e s ( in clu din g s o urc e d ocu m en ts r e la te d to A E/S AE, r e so lv e d q uerie s)

● Main te nance o f tr a ckin g o f S AE: r e ce ip t o f S AE r e p ort, c o ntr o l te rm s o f th eir

su bm is sio n to S ponso r, P ha rm aco lo gic a l C entr e / E C , s it e s

● In te ra ctio n w it h F in ancia l D epa rtm ent o f S po nso r r e g ard in g p aym ents to th e s it e s,

any d is cre pancie s b e tw een in vo ic e s a n d p aym en t o rd e rs , e tc .


Jan 2 010 – A ug 2 010 f r e e la n ce w ork in c lo th es d esig n.


Ju l 2 009 – J an 2 010, " C opir -c lu b" L TD .

Offic e m an ag er.

● Document flo w in t h e c o m pa ny

● Pla nnin g c o urie r’s d ay

● The o rg anis a tio n o f th e D ir e cto r’s b usin ess tr ip s

● Conductin g m eetin g s

● Main ta in s o ffic e s ta ff b y r e cru it in g , s e le ctin g, o rie ntin g, a nd tr a in in g e m plo ye es


Nov 2 008 – A pril 2 009 W WF, R ussia .

Head o f S ecre ta ria t.

● Work in g u nder th e s ta nda rd o p era tin g p ro ce dure s

● Tim ely p ro vid in g w it h in co m in g a nd o utc o m in g c o rre sp ondence

● Org aniz a tio n a nd m ain te na nce o f th e S ecre ta ry d epartm en t, r e cru it in g th e n ew

em plo ye es

● Support o f th e c o urie r w ork

● Pro vid in g th e m ark e tin g a naly sis a nd p re para tio n o f n ew s u pplie d c o m panie s

● Assis tin g to H eads o f W WF

● Passp ort a nd v is a s u ppo rt fo r th e fo und e m plo ye e. C olla bora tio n w it h th e c o nsu la r

departm ent o f th e M in is tr y o f F ore ig n A ffa ir s

● In s u bm is sio n: th re e s e cre ta rie s a nd c o urie r


Ju n 2 004 – N ov 2 008 – M ed ia c o m pan y S C H IB STE D , n et o f n ew sp ap ers « M oi R aio n»,

Mosco w .

2008 – o ffic e m an ag er.

● Work in g w it h th e c o nstit u e nt d ocu m ents a nd o th er le gally -re le va nt d ocu m en ts o f th e

co m pany

● Coopera tio n w it h t h e a cco untin g d epartm en t in c h arg e o f r e gis tr a tio n o f th e c u rre nt

ta ngib le a sse ts o f th e M osco w b ra nch o f th e c o m pa ny

● Negotia tin g, c o ntr a ctin g a n d im ple m enta tio n o f o ngoin g w ork w it h th e la ndlo rd ,

te le co m munic a tio n s a nd in su ra nce c o m panie s ( w ork in g w it h C BO s a nd p ro perty

in su ra nce c o m pan y)

● Pro vid e o ngoin g m ain te na nce o f te ch nic a l e quip m en t a nd p re m is e s o f th e c o m pa ny

● Purc h ase s o f g oo ds, s e rv ic e s, a nd w ork s to e nsu re th e s m oo th o pera tio n o f th e

offic e , c o ntr o l e xh ib it e d fo r p aym ent o f in vo ic e s fo r g oods s u pplie d, s e rv ic e s a nd

activ it ie s


Sin ce A pril 2 008, d ue t o A dm in is tr a tiv e d ir e cto r m ate rn it y le ave, c arrie d o ut h er

dutie s:

● Colle ctio n o f d ocu m en ts fo r r e gis tr a tio n o f e m plo ye es u nder th e la bour c o ntr a ct, th e

re gis tr a tio n d ata , c iv il c o n tr a cts fo r fr e e la nce rs a nd fo re ig n e m plo ye es

● Busin ess tr a ve l s u ppo rt

● Pre para tio n o f d ocu m ents f o r p aym ent o f s u pplie rs a cco untin g. S ig nin g a nd a ppro va l

of c o ntr a cts w it h s u p plie rs /c o ntr a cto rs

● Keep u p th e d ocu m en ts c ir c u la tio ns o f th e M osco w b ra n ch

● In s u bm is sio n, tw o r e ce ptio n is ts , th re e c o urie rs , c le aner, IT a dm in is tr a to r


2007 – 2 008 – o ffic e a d m in is tr a to r.

● The c o nduct o f n e gotia tio ns b y te le p hone

● Regis tr a tio n o f a ll in co m in g a nd o utg o in g d ocu m en ts

● Dra ftin g o f b usin ess le tte rs , d ra ft a dm in is tr a tiv e d ocu m en ts , ta kin g m in ute s o f

meetin gs

● Bookin g r o om s in h ote ls , a ir a nd r a ilw ay tic ke ts , in su ra n ce , e tc .

● Regula tin g th e flo w o f v is it o rs


2006 - 2 007 – c o m merc ia l d ep artm en t a ssis ta n t.

● Im ple m enta tio n o f th e c o lle ctio n o f m ate ria ls a nd in fo rm atio n r e q uir e d b y th e S ale s

Dir e cto r, p re para tio n o f a n aly tic a l, in fo rm atio nal, r e fe re n ce a nd o th er m ate ria ls a nd

pre se nt th em to th e h ea d

● Keep u p th e C RM ( c u sto m er d ata base ) tr a n sa ctio ns a nd s a le s m anagers w ork in g

outs id e th e o ffic e

● Keep u p th e document M anag em ent a t th e d epartm en t.


2004-2 006 – F re ela n ce c o p ywrite r.

● Cre atin g a dve rtis in g te xts , h e adli n es, a rtic le s a nd s lo gans fo r b oth c lie nts a nd

pers o nal n eeds o f th e c o m merc ia l s e rv ic e .


Addit io nal In fo rm atio n:
​Flu ent E nglis h , P C - a n e xp erie nce d u se r: M S O ff ic e ( w оrd, e xce l,

outlo ok, p ow erp oin t) , iO S, s ta n dard o ffic e e quip m en t.


Hobbie s:
​Readin g, m usic , tr a ve llin g, k n it tin g a nd e m bro id ery .


Pers o nal c h ara cte ris tic s :
​Org aniz a tio n, r e sp onsib ilit y , d ili g ence , c o m mit m en t, r e sis ta nce t o

str e ss, e asy tr a in abilit y .