CTA or Senior CTA, Single Sponsor dedicated, office-based in Warsaw, Poland

at  IQVIA

The IQVIA Sponsor-Dedicated Clinical Trials Assistant Team is supporting the project teams in the execution of clinical trials. Joining the team provides the opportunity to work with the preparation and documentation of clinical research projects in different therapeutic areas. You will be involved in data management, creation of study related documents and correspondence with internal departments, research sites and our client.
We currently have the exciting opportunity to join the team as Clinical Trials Assistant or Senior CTA in full-time to work in our office in Warsaw.

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
• Minimum of one year clinical research experience strongly preferred
• Fluent languages skills in Polish 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.

• Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.
• 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.
• Assist the clinical team with 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 for completeness.
• Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Assist with 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.
• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.