Job Overview

　　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.

　　Essential Functions

　　• 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. 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.

　　• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

　　• May collaborate with the clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.

　　Qualifications

　　• High School Diploma or equivalent Req

　　• 3-4 years administrative support experience.

　　• r Equivalent combination of education, training and experience.

　　• Minimum one year clinical research experience strongly preferred.

　　• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.

　　• Written and verbal communication skills including good command of English language.

　　• 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 requirement, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.

　　• Knowledge of applicable protocol requirements as provided in company training.

　　IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

　　IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

　　To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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