Clinical Trial Assistant - Single Sponsor, Romania

At IQVIA, we are committed to advancing healthcare through innovative clinical research. We are currently seeking an experienced Clinical Trials Assistant to join our Sponsor-Dedicated Functional Service Provider (FSP) team in Romania.

In this role, you will provide essential support to project teams in the successful execution of clinical trials across a variety of therapeutic areas. You will be responsible for managing study documentation, maintaining trial-related systems and records, coordinating communications with internal stakeholders and research sites, and ensuring that study activities are completed in accordance with applicable procedures and timelines.

RESPONSIBILITIES

• 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.

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 3 years clinical research experience strongly preferred
• Written and verbal communication skills including good command of English language.
• 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.