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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. This role requires working in a hybrid model, with regular attendance at the client's office in Buenos Aires city.

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 the 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

• Bachelor's degree in Life Science or related.

• Clinical research experience is required.

• Equivalent combination of education, training, and experience.

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

• Written and verbal communication skills, including a good command of the 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 requirements as provided in company training.

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IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com