Senior Clinical Trials Assistant, Single Sponsor dedicated, office-based in Kyiv, Ukraine
PharmaCROClinical ResearchRegulatory AffairsQuality Assurancecroinform
Job description
We currently have the exciting opportunity as Senior CTA in full-time to work in our office in Kyiv. Join our FSP team and play an important role in supporting the smooth delivery of clinical trials through effective coordination, documentation, and study support. Working closely with CRAs and RSU colleagues, you will help ensure quality and compliance while sharing your experience with newer CTAs. RESPONSIBILITIES Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines. Collaborate with clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files and completeness. Collaborate with CRAs and RSU on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow. Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation. Act as a mentor for less experienced Clinical Trial Assistants (CTAs). Assist with training and onboarding of new CTAs. May serve as subject matter expert for business processes. May lead CTA study teams. May assist with interviewing and screening of potential new team members May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training. May participate in departmental quality or process improvement initiatives. REQUIRED KNOWLEDGE, SKILLS AND EXPERIENCE Bachelor’s or higher-level Degree in life science or an apprenticeship in life science or office management plus administrative experience, preferable in the medical or pharmaceutical field of education and experience At least 2 years of clinical research experience as a CTA or in a similar role within a CRO or healthcare organization. Fluent languages skills in Ukrainian on at least C1 level and good command of English Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint Effective communication, organizational and planning skills Ability to work independently and to effectively prioritize tasks while working on multiple projects Ability to establish and maintain effective working relationships with coworkers, managers and clients. Please apply with your English CV. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
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