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Clinical Research Support Specialist
hace 2 meses
Clinical Trial Support Specialist, Dedicated to a Single Sponsor
Job Overview:
The Clinical Trial Assistant (CTA) is responsible for executing daily administrative tasks in collaboration with Clinical Research Associates (CRAs) and the Regulatory and Start-Up teams. This role is crucial for ensuring the comprehensive and precise delivery of the Trial Master File. By aiding in the coordination and management of study activities from initiation through execution and closure, the CTA guarantees the quality and consistency of study outputs in alignment with time, cost, and quality objectives.
Key Responsibilities:
Support CRAs and the Regulatory and Start-Up team in accurately updating and maintaining clinical documents and systems, such as the Trial Master File, to monitor site compliance and performance within project timelines. Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports, adhering to the defined scope of work and standard operating procedures. Conduct periodic reviews of study files to ensure completeness and accuracy. Collaborate with CRAs and the Regulatory and Start-Up team in the preparation, handling, and distribution of Clinical Trial Supplies, as well as maintaining tracking information. Oversee the management of Case Report Forms (CRFs), queries, and the flow of clinical data. Serve as a primary contact for the clinical team regarding designated project communications, correspondence, and related documentation. May work alongside the clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports in accordance with the scope of work and standard operating procedures.Qualifications:
High School diploma or University degree. Preferred experience in clinical research administrative support. Proficient in computer applications, including Microsoft Word, Excel, and PowerPoint. Strong written and verbal communication skills, with proficiency in both Spanish and English. Excellent time management and organizational abilities. Capacity to build and maintain effective working relationships with colleagues, supervisors, and clients. Basic understanding of relevant clinical research regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, as provided in company training. Familiarity with applicable protocol requirements as outlined in company training.IQVIA stands as a premier global provider of advanced analytics, technology solutions, and clinical research services tailored for the life sciences sector. Our mission is to challenge the limits of human science and data science to achieve significant impacts, ultimately aiding our clients in fostering a healthier world. Discover more about our initiatives at
