Clinical Trials Assistant, Cfsp

hace 3 semanas

Desde casa, México IQVIA A tiempo completo

**Job Overview** Perform daily administrative activities in collaboration with Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) teams to ensure the accurate delivery of the Trial Master File (TMF).**Essential Functions**- Assist CRAs and RSU teams with updating and maintaining clinical documents and systems (e.g., TMF) to track site compliance and performance within project timelines.- Support 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.- Conduct periodic reviews of study files for completeness.- Help CRAs and RSU with the preparation, handling, and distribution of Clinical Trial Supplies and maintain tracking information.- Track and manage Case Report Forms (CRFs), queries, and clinical data flow.- Serve 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**- Life science degree- Minimum of 3 years of administrative support experience.- ** Study Coordinator or CTA related experience is highly valued**- Equivalent combination of education, training, and experience will be considered.- Proficiency in Microsoft Word, Excel, and PowerPoint.- Excellent written and verbal communication skills, with a strong 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, including 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.LI-remote

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