Clinical Trial Assistant- HYBRID in Columbus, OH

IQVIA•Columbus, OH

2d•Hybrid

About The Position

The Clinical Trial Assistant supports Clinical Research Associates (CRAs) and the Regulatory and Start-Up (RSU) team by maintaining clinical documents and systems that track site compliance and performance within project timelines. The role assists with clinical documentation, study files, trial supplies, case report forms, queries, and clinical data flow. It also serves as a central contact for designated project communications and may support CRAs during site visits after completing required training. The position is described as hybrid in Columbus, Ohio.

Requirements

Bachelor's degree required.
Three years of administrative support experience.
Equivalent combination of education, training, and experience may be considered.
Computer skills, including working knowledge of Microsoft Word, Excel, and PowerPoint.
Written and verbal communication skills, including a good command of English.
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.

Responsibilities

Assist CRAs and the RSU team with accurately updating and maintaining clinical documents and systems, including the Trial Master File (TMF), to track site compliance and performance within project timelines.
Assist with preparing, handling, distributing, filing, and archiving clinical documentation and reports according to the scope of work and standard operating procedures.
Assist with periodic reviews of study files for completeness.
Assist CRAs and RSU with preparing, handling, and distributing Clinical Trial Supplies and maintaining tracking information.
Assist with tracking and managing 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 after completing required training.