Elena Trofimenko

Wet lab & dry lab genetic research specialist. Responsibilities: all stages of genetic laboratory sample processing from DNA extraction to sequencing, processing of sequenced data in Linux (STACKS) and data analysis with home R scripts, Statistica, Admixture, Structure, GenoDive, Excel, GraphPad Prism, etc

CRA in Phase II-III double-blind, double dummy, randomized, placebo/active-controlled studies. Responsibilities: management of clinical sites from initiation to close-out; ensuring protocol and GCP compliance; feasibility and site selection; site staff training; support in regulatory/ethical tasks; onsite and remote monitoring: ICF check, maintenance of CRF/CTMS/ISF/TMF, AE monitoring, IP accountability, query resolution; preparation for audits and regulatory inspections, resolution and FU on audit findings

CTA in Phase III-IV double-blind, double dummy, randomized, placebo/active-controlled studies. Responsibilities: preparation, handling, distribution, filing, and archiving of documentation; communication with the study sites regarding administrative issues; logistics management; supervision of ethical and regulatory submissions; assistance to CRAs and PMs/CTLs in study monitoring and management; maintenance of study tracking systems and databases

Project Assistant in Phase III-IV double-blind, double dummy, randomized, placebo/active-controlled studies. Responsibilities: preparation, handling, distribution, filing, and archiving of documentation; communication with the study sites regarding administrative issues; logistics management; supervision of ethical and regulatory submissions; assistance to CRAs and PMs/CTLs in study monitoring and management; maintenance of study tracking systems and databases; management of Investigator payments

Onsite Coordinator in Phase II-III blind randomized placebo-controlled studies. Responsibilities: communication with subjects regarding study visits, and with CRAs/CTAs regarding administrative issues; ISF maintenance and assistance with CRF data input; safe restricted-access storage of IP; logistics management, including timely dispatch of temperature-sensitive biomaterial for analysis; assistance to Investigator in all organizational issues