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Clinical Research Associate I
70191, Stuttgart, Im Goetzen, 10
[
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Available working permit in Germany.
Education 2001–2007
National Technical University of Ukraine “Igor Sikorsky Kyiv Polytechnic
Institute”, Ecological devices, Specialist degree.
Professional May 2022 - July 2023
Experience Clinical Research Associate I
ICON Clinical Research GmbH, Langen
- Responsibilities include identification, selection, initiation, and
close-out of appropriate investigational sites for clinical studies.
Monitor those sites in order to ensure that studies are carried out
according to the study protocol,
- ICON SOPsfWPs, applicable regulations and the principles of ICH-
GCP
- Involvement, when required, in other areas of study management
and staff training.
- Contribute to the review of ICON systems and procedures, as
appropriate.
- Contribute to the culture of process improvement with a focus on
streamlining our processed adding value to our business and
meeting client needs.
- Recognize, exemplify and adhere to ICON's values which center
around a commitment to People, Clients and Performance.
- Independently and proactively coordinate the necessary activities
required to set up and monitor a study.
Study Assignments:
A multicenter, randomized, double-blind, placebo-controlled, parallel
group study to evaluate the efficacy and safety of XXX in adult patients
with bullous pemphigoid
• Countries handled: Germany (5 sites)
• Study stage handled: Monitoring and Readiness to Study
Closeouts
• Trial Master File reconciliation
April 2018 - February 2020
Study Support Assistant
LLC «ICON Clinical Research», Kyiv
- Provide general administrative support to Study Start Up team,
Support the Study Start Up leads including tracking, filing and other
coordinating tasks,
- Amendments to contracts preparation, budget calculation,
negotiation with external Sites, coordinate amendments signing, filing,
inform account department,
- Assist in coordination of payments to authorities, tracking acts of
accepting with authorities,
- Perform timely and accurate data entry of regulatory documents,
submission status in the appropriate clinical trial management systems,
- Local Ethics Committee approvals collect from the Sites,
communicates with Sites on document updates and corrections,
- Organize printing of submission documents by vendor according
to the Regulatory Authority requirements
- Assist in the translation of documents required to authorities,
- Assemble and distribute study materials to study Sites.
February 2015 – April 2018
Facilities and Administration, Receptionist
LLC «ICON Clinical Research», Kyiv
- Act of Acceptance to the Sites (preparing Act of Acceptance on
base of agreements with hospitals and investigators, solving issues with
costs refund with Finance department, sending letter about refunds,
control bank details changing according Beneficiary details form, Site
payments file update, control documents signing on the Sites, organize
documents pick ups from the Sites, keep Acts of acceptance register)
- Finance (submission invoices from Suppliers to the finance
departments, invoices coding, setting expense reports of employees,
organizing signing specimen signature and seal card for the bank, way
bills and fuel reports submittion)
- IT (Cooperation with telecommunication company, local IT
supplier, helping Colleagues by urgent IT issues, organizing visits of local
IT specialist, accepting IT equipment, control storing)
- HR (Helping by process of Employees Income/Outcome,
coordinate signing HR documents, sick leaves list register, cooperation
with HR department).
- Front Desk Reception Services (business trip orders and
certificates preparation, travel plan update, housekeeping, coordinate
car service, visitors registration, incoming courier tracking form,
coordinate dispatch of interoffice consignment, control shipments, faxes
blinded\unblinded information, monitor and respond to customer
requests through Facilities Online, ensuring timely response and
resolution of issues)
Skills Languages: English – upper-intermediate,
German – B2.
Computer skills: Proficient in MS Office
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