Clinical Trial Documentation & Compliance Assistant

Regulatory Toolkit

Columbus (OH)

On-site

USD 36,000 - 123,000

Full time

4 days ago

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Job summary

IQVIA is a leading global provider of clinical research services, insights and healthcare intelligence. This role assists CRAs and the RSU team with updating TMF and handling clinical documentation, ensuring site compliance within project timelines.

The position supports the preparation, filing, and archiving of documents, reviews study files for completeness, and helps manage the distribution of Clinical Trial Supplies and data flow. Base pay range is disclosed with potential bonuses.

Qualifications

Bachelor's Degree required.
3 years administrative support experience.
Equivalent combination of education, training and experience.
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.

Responsibilities

Assist CRAs and RSU with updating TMF and other documents.
Prepare, handle, distribute, file and archive clinical documents and reports.
Review study files for completeness.
Assist with distribution of Clinical Trial Supplies and tracking information.
Track and manage Case Report Forms (CRFs), queries and data flow.
Serve as central contact for designated project communications and associated documentation.
May accompany CRAs on site visits for monitoring duties after training.