Резюме: Регуляторный специалист (Україна)

Досвід роботи

<p>OBJECTIVE:
to obtain position of Regulatory Specialist, Start up
coordinator (remote, full-time, part-time)</p>
<p>
</p>
<p>
<strong>Education: </strong>National
Pedagogical University named after Mikhail Drahomanov (Institute
of Correction Pedagogy and Psychology).</p>
<p>
</p>
<p><strong>EXPERIENCE:</strong></p>
<p>
</p>
<p><strong>June
2017-May 2019 AstraZeneca LLC, Regulatory
specialist:</strong></p>
<p>
Duties and responsibilities:</p>
<ul><li>
<p>Assist
in coordination and administration of clinical studies from the
start-up to execution and close-out.</p>
</li></ul><ul><li>
<p>
Collect,
assist in preparation, review and tracking of documents related to
Submissions
to
Expert Center MOH Ukraine.
Interface with Investigators and
Local Study Leaders
during
the collection process to support effective delivery of a study and
its documents. Serve as local administrative main contact and work
closely with
Study Manager
and/or
the LSLs
until finalization of the study.
</p>
</li><li>
<p>
Download clinical
regulatory documents to
the Global Electronic Library according the Global Document List.</p>
</li><li>
<p>
Prepare ICF according local
templates (initial
and actual).</p>
</li><li>
<p>
Maintain regulatory
documents, monitor and recommend improvements for tracking
regulatory documents.
</p>
</li><li>
<p>
Collaborate on development of
standard operating procedures, trainings and documentation.
Participate
in delivering trainings.
</p>
</li></ul><p> <strong>January
2016-May 2017 AstraZeneca,
LLC Clinical Trial Assistant-LEC
Coordinator:</strong></p>
<p>
Duties and responsibilities:</p>
<p>
</p>
<ul><li>
<p>Ensuring overall project
maintenance according
project timelines and goals.</p>
</li><li>
<p>Assisting with the creation and
review of technical and administrative documentation</p>
</li><li>
<p>Prepare and submit IRB/IEC
application and follow up until final approval received (initial
submission and amendments)</p>
</li></ul><ul><li>
<p>Operational
responsibility to set-up the local Trial Master File (eTMF) and ISF
including tracking of documents. Maintain and close the local TMF
(in electronic or paper form depending on study) ensuring
International Conference of Harmonisation Guidelines for Good
Clinical Practice (ICH/GCP) compliance and local requirements.
Support the CRA in the maintenance and close out activities for the
ISF.</p>
</li><li>
<p> Contribute
to the production and maintenance of study documents, ensuring
template and version compliance. Translate or give the appropriate
support with the translation of documents when required.
</p>
</li><li>
<p> Set-up,
populate and accurately maintain information in AstraZeneca tracking
and communication tools (e.g. IMPACT, SharePoint etc) and support
others in the usage of these systems
</p>
</li><li>
<p> Manage
and contribute to coordination and tracking of study materials and
equipment</p>
</li><li>
<p> Coordinate
administrative tasks duringthe study process, audits and regulatory
inspections, according to company policies and SOPs</p>
</li><li>
<p> Prepare,
contribute to and distribute presentation material for meetings,
newsletters and web-sites</p>
</li><li>
<p> Responsible
for layout and language control, copying and distribution of
documents. Support with local translation and spell checks in
English to/from local language</p>
</li><li>
<p> Responsible
for printing and distribution of documents such as letters and
meeting minutes, and for handling and archiving of study related
e-mails</p>
</li><li>
<p>Participation
in internal study team meetings, organizing study-specific meeting
for Investigators; planning and execution of local investigator
meetings
</p>
</li></ul><p><strong>A</strong><strong>pril
2015-December 2015 AstraZeneca LLC, Labor Code Specialist</strong></p>
<p><strong>September
2009-September
2014 Istil
Studios LLC,
Labor
Code Specialist</strong></p>
<p><strong>June
2008-February 2009- Favorit LVP, Labor
Code Specialist</strong></p>
<p>
Duties and responsibilities:</p>
<ul><li>
<p>
Work with department manager
to fill internal positions</p>
</li><li>
<p>Work
with department managers update job descriptions and position
requirements</p>
</li></ul><ul><li>
<p>Work with
managers to source and screen applicants</p>
</li></ul><ul><li>
<p>Work with
recruitment agencies to find ideal contractor candidates</p>
</li></ul><ul><li>
<p>Work with staff to edit and
maintain employee resume library
</p>
</li><li>
<p>Coordinate
and scheduled interviews with interview panelists
</p>
</li><li>
<p>
Develop employee health and
safety policies</p>
</li></ul><p>
</p>
<p><strong>Skills:</strong></p>
<p>
</p>
<ul><li>
<p>Good organizational and time
management skills; ability to adhere to timelines
</p>
</li><li>
<p>Producing weekly and monthly
regulatory reports for Managers
</p>
</li><li>
<p>Ability to solve practical
problems and deal with a variety of concrete variables in situations
where only limited standardization exists
</p>
</li><li>
<p>Very strong attention to detail
</p>
</li><li>
<p>Excellent communication and team
leadership skills with strong managerial skills
</p>
</li><li>
<p>Excellent writing, communication and interpretive skills</p>
</li><li>
<p>English-intermedia</p>
</li></ul><p><strong>Hobbies:</strong></p>
<p>Yoga,
travelling.</p>