IQVIA
life sciences
ClinicalTrialAssistant
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Clinical Trial Assistant at IQVIA. Skills: Clinical documentation, File management. Perform daily administrative activities. Assist with updating and maintaining clinical documents and”
What You'll Achieve.
Ensure complete and accurate Trial Master File delivery
Industry & Context.
What They're Looking For.
Must Have
High School Diploma or equivalent, 3 years administrative support 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, Knowledge of applicable protocol requirements
Nice to Have
Equivalent combination of education, training and experience
What You'll Do.
Perform daily administrative activities
Assist with updating and maintaining clinical documents and
Assist with preparation
Assist with periodic review of study files for
Assist with preparation
handling and distribution of Clinical
Assist with maintenance of tracking information
Assist with tracking and management of Case Report
Assist with tracking and management of queries
Assist with tracking and management of clinical data
Act as a central contact for clinical team
Act as a central contact for project correspondence
Act as a central contact for associated documentation
Accompany CRAs on site visits
Assist with clinical monitoring duties
How You'll Work.
Team & Collaboration
Clinical Research Associates; Regulatory and Start-Up teams
Communication Scope
Written communication; Verbal communication
Full Job Description
**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. * 3 years administrative support experience. * 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 requirements as provided in
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