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IQVIA · 1 day ago

Clinical Trial Assistant- Wilmington, DE

Parsippany, NJ

Full-time

Onsite

Mid Level

$34K/yr - $119K/yr

3+ years exp

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. The Clinical Trial Assistant will support CRAs and the RSU team in maintaining clinical documents and systems, assisting with documentation and reports, and managing study files.

AnalyticsHealth CareLife Science

Responsibilities

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

Qualification

Clinical research knowledgeMicrosoft Office proficiencyTime managementOrganizational skillsGCP awarenessICH guidelines awarenessWritten communicationVerbal communicationInterpersonal skills

Required

Bachelor's Degree Required

3 years administrative support experience

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