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 performing essential administrative functions in collaboration with Clinical Research Associates (CRAs) and the Regulatory and Start-Up teams. This role is crucial for ensuring the accurate and complete 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 established time, cost, and quality objectives.
Key Responsibilities:
Collaborate with CRAs and the Regulatory and Start-Up team to ensure the precise updating and maintenance of clinical documents and systems, such as the Trial Master File, which monitors site compliance and performance against project timelines. Support the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports, adhering to the scope of work and standard operating procedures. Conduct periodic reviews of study files to verify completeness and accuracy. Assist CRAs and the Regulatory and Start-Up team with the preparation, handling, and distribution of Clinical Trial Supplies, as well as maintaining tracking information. Manage the tracking and flow of Case Report Forms (CRFs), queries, and clinical data. Serve as a primary contact for the clinical team regarding designated project communications, correspondence, and related documentation. May collaborate with the clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports in accordance with the defined scope of work and standard operating procedures.Qualifications:
High School diploma or University degree. Previous experience in clinical research administrative support is preferred. 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 establish and maintain effective working relationships with colleagues, supervisors, and clients. Basic understanding of relevant clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, as provided through company training. Familiarity with applicable protocol requirements as outlined in company training.IQVIA is a premier global provider of advanced analytics, technology solutions, and clinical research services tailored for the life sciences sector. Our mission is to advance human science and data science to maximize impact, ultimately assisting our clients in fostering a healthier world. Discover more about our initiatives at
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