Clinical Trial Assistant - Single Sponsor, Romania
IQVIA · Bucharest
At IQVIA, we are committed to advancing healthcare through innovative clinical research. We are currently seeking a Senior 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.
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.