Description
IQVIA is seeking an experienced Clinical Trials Assistant to join their 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 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.
- Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports.
- 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, preferably in the medical or pharmaceutical field.
- 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, organisational and planning skills.
- Ability to work independently and to effectively prioritise tasks while working on multiple projects.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.