Professional Freelancer

• Feb 2022 - Present

In-house Clinical Research Associate I

• Aug 2019 - Feb 2022

Serving as contact for project team and investigative sites, •Assisting CRAs with preparation for site visits (i.e. running reports, QC of files (checking for missing documents), resolving action items from previous visits). •Performing Case Report Form review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management. •Liaising with the international Project Team in the performing of project-specific tasks. •Assisting in submissions and notifications to Ethics Committees and Regulatory Authorities. •Responsible for General On-Site Monitoring: Assisting Senior CRAs, CRA-2 and CRA-1 with on-site tasks as required and according to training goals (e.g. reviewing of Case Report Forms and Study File Notebook, drug accountability). •Performing eTMF maintenance (uploading documents, QC) •Facilitating translation and back translation of all necessary documents, as appropriate for local country requirements. •Undertaking other project related administrative tasks (i.e. system access tracking, visits tracking, site document preparation) as appropriate, as assigned by the project Manager and CTL. •Submitting SUSARs to Russian Ministry of Healthcare Show less

CRA Assistant

• Nov 2015 - Aug 2019

Acting as contact for project team and study sites. •Assisting with generation and reconciliation of queries to investigative sites/clients to resolveproblem data. Ensuring compliance with Covance S.O.P.s, FDA, ICH, and GCP regulationsfor clinical conduct in all aspects of daily work. •Assisting in submissions and notifications to Ethics Committees and Regulatory Authorities. •Co-ordinating teleconferences with clients, investigators, and project team, including takingminutes. •Keeping electronic Trial Master File up-to-date (different systems for different projects). • Reviewing written translations performed by third-party vendors. •Working with currier services (DHL, Translog). •General On-Site Monitoring Responsibilities: •Assisting Senior CRAs, CRA-2 and CRA-1 with on-site tasks as required and accordingto training goals (review of Case Report Forms and Study File Notebook). •Performing other duties as assigned by management. Show less

Head of the Translations Department

• May 2013 - Nov 2015

•Performing the analysis of the complexity of documents and distributing tasks amongtranslators; •Facilitating translation and editing in pairs English/Russian and German/Russian of documentsin the field of medicine, pharmaceuticals, clinical trials, technical documentation; •Liaising with third-party translation vendors; •Reviewing translations performed by third-party vendors; •Cooperating with company departments to meet the requirements to translation quality; •Performing consecutive translation in pairs English/Russian as necessary; Show less

Translator

• Nov 2007 - May 2013

•Performing translation in pairs English/Russian and German/Russian of documents in the fieldof medicine, pharmaceuticals, biotechnology, clinical studies as well as technical and regulatorydocumentation; •Drafting and translating business letters; •Performing consecutive translation in pairs English/Russian as necessary; •Performing translation in pairs English/Russian and German/Russian of documents in the fieldof medicine, pharmaceuticals, biotechnology, clinical studies as well as technical and regulatorydocumentation; •Drafting and translating business letters; •Performing consecutive translation in pairs English/Russian as necessary;