CTA

IQVIA — Thane, Maharashtra, India

Job Description Summary 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. • 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. Qualifications • High School Diploma or equivalent Req • 3 years administrative support experience. • r. • Equivalent combination of education, training and experience. • 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. • Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training. • Knowledge of applicable protocol requirem

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