IQVIA
CTA(Beijing)
Neural analysis suggests this role is
optimal for Mid+ candidates.
“CTA (Beijing) at IQVIA. Skills: Trial Master File delivery, clinical documents and systems, site compliance and performance, clinical documentation and reports, Clinical Trial Supplies, Case Report Forms (CRFs), clinical data flow. 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.. Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU)”
What You'll Achieve.
ensure a complete and accurate Trial Master File delivery; track site compliance and performance within project timelines
Industry & Context.
May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
What They're Looking For.
Must Have
Bachelor's degree and above, 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 company training
What You'll Do.
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.
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
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.
How You'll Work.
Team & Collaboration
in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams; Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team; Assist the clinical team; Assist CRAs and RSU; Act as a central contact for the clinical team; accompany CRAs on site visits
Communication Scope
Written and verbal communication skills; good command of English language; project communications, correspondence and associated documentation
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 • Bachelor's degree and above. • 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 company training IQVIA is a leading global provider of clinical
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