Clinical Trial Coordinator
hace 2 meses
Job Summary:
Clinical Trial Assistant - Sponsor Dedicated
Job Overview:
The Clinical Trial Assistant plays a crucial role in ensuring the smooth execution of clinical trials by providing administrative support to the Clinical Research Associates and Regulatory and Start-Up teams. This includes coordinating and administering study activities from start-up to execution and close-out, ensuring quality and consistency of study deliverables within time, cost, and quality objectives.
Key Responsibilities:
- Assist in updating and maintaining clinical documents and systems, such as the Trial Master File, to track site compliance and performance within project timelines.
- Support the clinical team in preparing, handling, distributing, filing, and archiving clinical documentation and reports according to the scope of work and standard operating procedures.
- Review study files for completeness and assist in maintaining accurate records.
- 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.
- Collaborate with the clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports.
Requirements:
- High School or University Diploma
- Clinical research administrative support experience preferred
- Computer skills, including working knowledge of Microsoft Word, Excel, and PowerPoint
- Strong written and verbal communication skills, including proficiency in English and Spanish
- Effective time management and organizational skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
- Basic knowledge of applicable clinical research regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Knowledge of applicable protocol requirements
About IQVIA:
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We strive to make a meaningful impact by pushing the boundaries of human science and data science to create a healthier world.
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