Olga Konshina
Sugarland,USA
Summary
I am a Clinical Research Professional with a recent addition as a Start-Up Manager with a strong background in vaccine studies. An excellent team player and collaborator (worked on projects for Euro WHO/CDC). Skilled at preparing specimens and samples, with proven adeptness in troubleshooting, interpreting, and reproducing assays by utilizing different techniques. Excellent problem-solving abilities with detail orientation. I am a Focused Clinical Research Professional well-versed in study protocols, standard operating procedures and general trial oversight. I'm looking to seek a position as Clinical Trial Manager and excited to bring 18 years of research experience to a challenging new role.
Overview
18
18
years of professional experience
Work History
Senior Study Coordinator & Start-Up Manager
DM Clinical Research
07.2022 - Current
- Prepares key reports on study progress and assists in delegated clinical study management responsibilities
- Serves as contact for interacting with and conveying study information to data management, safety, regulatory personnel, and other functional or departmental groups, as necessary
- Provides clinical input in the development of case report forms, data management plans, and data listings reviews
- Leads meetings with CROs, vendors, and multi-functional teams on a day-to-day basis to ensure quality, budget, and timeliness of deliverables, as necessary
- Reviews site invoices to ensure that clinical expenses are in accordance with work conducted
- Assists in the evaluation of vendor performance to ensure early mitigation/resolution of potential issues and serve in a key role to develop/implement corrective action plans as appropriate
- Coordinates training of CRO staff, vendors, investigators, and study coordinators on study requirements and SOPs
- Resolves escalated study conduct issues and provides clinical responses to questions from study centers and institutional review boards/ethics committees
- Reviews escalated issues from CRAs to ensure adequate mitigation plans are implemented
- Provides oversight of CTMS tracking to support evaluation and continual management of clinical study set-up and follow-up study activities, as needed
- Monitors adherence to the regulatory/essential document collection process and release of clinical supplies
- Provides assistance in the management of the trial master file process, including ongoing maintenance, accurate filing, and administration of quality control (QC) plan.
- Mentor in the Peer-to-Peer Program for DM Clinical Research.
Clinical Research Coordinator/Study Coordinator
DM Clinical Research
03.2020 - 07.2022
- Worked on several high enrolling FDA-Approved COVID-19 trials
- Monitoring research participants to ensure adherence to study rules
- Adhering to research regulatory standards
- Adhering to ethical standards
- Maintaining detailed records of studies as per FDA guidelines, including things such as drug dispensation
- Ensuring that the necessary supplies and equipment for a study are in stock and in working order.
Clinical Trials Assistant/Clinical Research Coordinator/Co-Investigator
Research Institute of Influenza, WHO National Influenza Center, Ministry Of Health
09.2009 - 04.2020
- Screened patient records, databases and physician referrals to identify prospective candidates for research studies
- Tracking and management of Case Report Forms (CRFs), queries and clinical data flow
- Maintaining study timelines in MS Project
- Supporting CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
- Assist with review of clinical trial related invoices
- Copying, scanning, filing.
Senior Clinical Research Coordinator/Study Coordinator
Research Institute of Influenza, WHO National Influenza Center, Ministry Of Health
04.2015 - 03.2020
- Coordinated, organized and maintained all study documentation including source documentation, case report forms (maintained accurate records of Adverse Events, expedited reports of Serious Adverse Events), study and regulatory binders and patient binders
- Oversaw adherence to study protocol for influenza vaccine/new influenza treatment and clinical patient evaluations, treatment administration, and collection, processing, and shipping of biological specimens
- Prepared and processed all documentation through the Institutional Review Board (IRB), including submissions, continuing reviews, amendments and adverse event reporting
- Prepared for and participated in audits conducted by sponsors and other oversight entities such as CHOP's Regulatory and Compliance Office
- Managed all day-to-day activities necessary to facilitate the successful completion of a few trials at one time.
Junior Researcher/ Researcher/ Senior Researcher
Research Institute of Influenza, WHO National Influenza Center, Ministry Of Health
08.2006 - 03.2020
- Performs research and development work under the guidance of the Head Laboratory
- Perform ongoing literature review to remain current with new procedures and related research; present findings for lab work group
- Have at 3 first-author paper in a peer-reviewed journal
- Development ELISA test to Coronavirus H228E (from beginning to the final)
- Participate in the preparation of written documents, including procedures, presentations, and proposals
- Compliantly order materials and reagents for ongoing projects in the lab
- Process biospecimens including blood and serum/plasma
- Maintain and organize sample repositories
- Conduct molecular biology assays including qPCR, HI, immunoblotting, ELISAs
- Maintain and organize sample repositories for study herd immunity of population in Russia 2009-2018
- Work with mouse, rabbit, egg embryo.
Education
Master of Science - Applied Mathematics And Physics
St. Petersburg State Polytechnic University
St. Petersburg, Russia06.2008
Master Erasmus Student Program - Quality Control And Safety Technologies
Czech Technical University in Prague (České Vysoké
PRAGUE CZECH06.2007
Bachelor of Science - Technical Physics
St. Petersburg State Polytechnic University
Saint-Petersburg, The Russian Federation06.2006
Skills
Team Player and effective communicator
Great at managing multi tasking and detail oriented
Documentation Management
Problem Resolution
First Aid/CPR
Flexible and Adaptable
Languages
English
Full Professional
Russian
Native or Bilingual
German
Limited Working
Timeline
Senior Study Coordinator & Start-Up Manager
DM Clinical Research
07.2022 - Current
Clinical Research Coordinator/Study Coordinator
DM Clinical Research
03.2020 - 07.2022
Senior Clinical Research Coordinator/Study Coordinator
Research Institute of Influenza, WHO National Influenza Center, Ministry Of Health
04.2015 - 03.2020
Clinical Trials Assistant/Clinical Research Coordinator/Co-Investigator
Research Institute of Influenza, WHO National Influenza Center, Ministry Of Health
09.2009 - 04.2020
Junior Researcher/ Researcher/ Senior Researcher
Research Institute of Influenza, WHO National Influenza Center, Ministry Of Health
08.2006 - 03.2020
Master of Science - Applied Mathematics And Physics
St. Petersburg State Polytechnic University
Master Erasmus Student Program - Quality Control And Safety Technologies
Czech Technical University in Prague (České Vysoké
Bachelor of Science - Technical Physics
St. Petersburg State Polytechnic University
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