
Administrative Coordinator for Clinical Trials
2 semanas atrás
Clinical Trials Assistant I – Hybrid Role
This position is responsible for performing daily administrative activities in conjunction with the Clinical Research Associates and Regulatory teams to ensure a complete and accurate Trial Master File delivery.
Key Responsibilities- Assist Clinical Research Associates (CRAs) and Regulatory teams with updating and maintaining clinical documents and systems that track site compliance and performance within project timelines.
- Prepare, handle, distribute, file, and archive clinical documentation and reports according to standard operating procedures.
- Review study files for completeness on a periodic basis.
- Support CRAs and Regulatory teams with preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Track and manage Case Report Forms (CRFs), queries, and clinical data flow.
- Act as a central contact for designated project communications, correspondence, and associated documentation.
- May accompany CRAs on site visits to assist with clinical monitoring duties after completion of required training.
- High School Diploma or equivalent.
- Previous experience working with CEP/CONEP.
- Proficiency in Microsoft Word, Excel, and PowerPoint.
- Strong written and verbal communication skills with good command of the English language.
- Awareness of applicable clinical research regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Knowledge of protocol requirements.
IQVIA is a leading 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 improve patient outcomes and population health worldwide.
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