Clinical Trial Assistant
About The Position
The Clinical Trial Assistant supports Clinical Research Associates (CRAs) and the Regulatory and Start-Up (RSU) team with maintaining clinical documents and systems, preparing and managing trial documentation and supplies, tracking study data and communications, and reviewing study files. The role may include accompanying CRAs on site visits to assist with clinical monitoring duties after completing required training. IQVIA is a global provider of clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries. The company describes its work as connecting these capabilities to accelerate the development and commercialization of medical treatments and improve patient outcomes and population health.
Requirements
- Bachelor's degree required.
- Three years of administrative support experience.
- Equivalent combinations of education, training, and experience are accepted.
- 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, to track site compliance and performance within project timelines.
- Assist the clinical team 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.
- Serve as a central contact for designated project communications, correspondence, and associated documentation for the clinical team.
- 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
