IQVIA
Life Sciences
ClinicalTrialsAssistant
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Clinical Trials Assistant at IQVIA. Skills: Clinical documentation, Trial Master File, Regulatory compliance. Perform daily administrative activities. Update and maintain clinical documents”
What You'll Achieve.
Complete Trial Master File delivery
Industry & Context.
Site visits
What They're Looking For.
Must Have
Master's Degree in Life Sciences, Computer skills, Working knowledge of Microsoft Word, Working knowledge of Excel, Working knowledge of PowerPoint, Written communication skills, Verbal communication skills, Good command of English language, Effective time management skills, Organizational skills, Ability to establish and maintain effective working relationships, Awareness of applicable clinical research regulatory requirements, Knowledge of applicable protocol requirements
What You'll Do.
Perform daily administrative activities
Update and maintain clinical documents
Maintain clinical systems
Track site compliance
Track site performance
Assist with preparation of clinical documentation
Assist with handling of clinical documentation
Assist with distribution of clinical documentation
Assist with filing of clinical documentation
Assist with archiving of clinical documentation
Perform periodic review of study files
Assist with preparation of Clinical Trial Supplies
Assist with handling of Clinical Trial Supplies
Assist with distribution of Clinical Trial Supplies
Maintain tracking information for supplies
Track Case Report Forms
Manage Case Report Forms
Track clinical data flow
Manage clinical data flow
Act as central contact for clinical team
Manage project communications
Manage project correspondence
Manage 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; Clinical team
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 • Master's Degree in Life Sciences • 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 company training. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare inte
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