Clinical Trial Assistant- HYBRID in Columbus, OH
IQVIA•Columbus, OH
•$35,800 - $123,000•Hybrid
About The Position
The Clinical Trial Assistant supports Clinical Research Associates (CRAs) and the Regulatory and Start-Up (RSU) team by maintaining clinical documentation and systems, including the Trial Master File (TMF), and helping track site compliance and performance within project timelines. The role also supports clinical documentation workflows, clinical trial supply tracking, Case Report Form (CRF) and query management, and project communications. After completing required training, the assistant may accompany CRAs on site visits to support clinical monitoring duties.
Requirements
- Bachelor's degree.
- Three years of administrative support experience, or an equivalent combination of education, training, and experience.
- 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
- Accurately update and maintain clinical documents and systems, such as the Trial Master File, to track site compliance and performance within project timelines.
- Prepare, handle, distribute, file, and archive clinical documentation and reports according to the scope of work and standard operating procedures.
- Periodically review study files for completeness.
- Support the preparation, handling, and distribution of Clinical Trial Supplies and maintain related tracking information.
- Assist with tracking and management of Case Report Forms (CRFs), queries, and clinical data flow.
- Serve as a central contact for designated project communications, correspondence, and associated documentation.
- May accompany CRAs on site visits to assist with clinical monitoring duties after completing required training.
Benefits
- Health and welfare benefits may be offered, depending on the position.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
