Olga S Konshina

• Manage global clinical trials (technical, clinical utility, clinical performance) from start-up through close-out, ensuring delivery on time, within budget, and in full regulatory compliance (GCP, FDA, ISO, IVDR).
• Lead cross-functional teams and serve as the primary liaison among internal stakeholders, CROs, vendors, investigators, and clinical sites to drive efficient study execution.
• Oversee protocol development, CRF design, data management plans, and clinical data review to ensure accuracy, consistency, and regulatory readiness.
• Prepare key study metrics and progress reports; proactively identify and resolve issues escalated by CRAs, sites, and vendors.
• Coordinate training for study teams, review site invoices for compliance with contracted terms, and monitor vendor performance, implementing corrective actions as needed.
• Maintain real-time CTMS tracking and ensure audit-ready Trial Master File (TMF) and essential documentation throughout the study lifecycle.
• Support regulatory submissions by ensuring high-quality clinical data and documentation aligned with global regulatory requirements.

• Coordinated daily activities of research protocols, including screening, enrollment, monitoring, and scheduling study visits for participants.
• Managed participant visits, ensuring all clinical procedures, lab tests, and protocol-specific activities were completed per study requirements.
• Identified and reported adverse events/serious adverse events in compliance with protocol, regulatory guidelines, and institutional policies.
• Developed methods for tracking and reporting data to sponsor’s monitors, ensuring data integrity and regulatory compliance.
• Collaborated with cross-functional teams to ensure smooth study operations and adherence to timelines and regulatory standards.

• Coordinated and maintained study documentation, including source documents, case report forms, and patient binders, ensuring accurate records of adverse events and serious adverse events.
• Oversaw adherence to study protocols for influenza vaccine trials, including clinical evaluations, treatment administration, and specimen collection.
• Managed IRB submissions, continuing reviews, amendments, and adverse event reporting.
• Prepared for and participated in audits by sponsors and regulatory bodies, ensuring compliance with study protocols.
• Managed multiple clinical trials simultaneously, ensuring timely and successful completion of all study activities.

• Conducted Site Initiation Visits (SIV), training sites on protocols, regulatory standards, study procedures and monitoring visits.
• Coordinated site closeout activities, ensuring all study documentation was complete, data integrity was maintained, and regulatory requirements were met.
• Managed IRB submissions, adverse event reporting, patient visits, and audit preparation, ensuring compliance with study protocols and regulatory standards.
• Worked on both investigator-initiated and industry-sponsored trials, contributing to traditional and mRNA-vaccine research, as well as therapeutic studies focused on treatment efficacy and public health outcomes.
• Known for strong attention to detail, organizational skills, and the ability to manage multiple studies simultaneously while ensuring high standards of patient safety and data integrity.
• Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.

• Conducted research and development under the guidance of the Head of Laboratory; performed ongoing literature reviews to refine lab methodologies and protocols.
• Authored 3 first-author publications in peer-reviewed journals, contributing to advancements in virology and immunology.
• Developed an ELISA test for Coronavirus H228E, leading the project from concept through final validation.
• Processed biospecimens (blood, serum/plasma) and maintained organized sample repositories for long-term herd immunity studies (Russia, 2009–2018).
• Performed molecular biology assays including qPCR, hemagglutination inhibition (HI), immunoblotting, and ELISA techniques.
• Participated in drafting lab procedures, research presentations, and grant proposals.
• Managed compliant procurement of lab materials and reagents to support ongoing research projects.
• Worked with animal models including rabbits, mice, and chicken embryos, supporting in vivo experiments and sample generation.

• Coordinated, organized, and maintained all study documentation including source documentation, case report forms (maintaining accurate records of Adverse Events and expedited reports of Serious Adverse Events), study and regulatory binders, and patient binders.
• Oversaw adherence to study protocols involving influenza vaccines and novel influenza treatments, including clinical patient evaluations, treatment administration, and collection, processing, and shipping of biological specimens.
• Prepared and submitted all necessary documentation to the Institutional Review Board (IRB), including initial submissions, continuing reviews, amendments, and adverse event reporting.
• Prepared for and actively participated in audits conducted by sponsors and oversight bodies such as CHOP’s Regulatory and Compliance Office.
• Managed the day-to-day operational aspects of multiple concurrent clinical trials to ensure timelines and regulatory requirements were met.
• Contributed to vaccine production research, including studies on mRNA-based vaccines, focusing on immunogenicity, stability, and delivery mechanisms.
• Participated in research on herd immunity thresholds and population-based vaccine coverage models to support public health strategies.
• Conducted statistical analysis for publications assessing the clinical efficacy of vaccines, including data management, outcome interpretation, and manuscript preparation for peer-reviewed journals.

• Studied the main evolutionary patterns of the development of intellectual activity in primates of different levels of phylogeny, from representatives of lower monkeys (marmoset) to the most highly organized primates (chimpanzees)
• Prepared fact sheets, tables and graphs to summarize research results
• Interpreted and analyzed research data to draw conclusions on outcomes
• Basic animal care