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Clinical Administrative Assistant


RESPONSIBILITIES & ACCOUNTABILITIES
o Responsible for study record maintenance.
o Assists clinical operations personnel with study-support activities such as IBIS2 data entry, IBIS2 report generation, site accreditation and activation, study supply creation, organization, preparation and shipment.
o Provides administrative support to the clinical operations department and project teams.
o Assists with QA documentation and record retention per the applicable SOPs.
o Assists with clinical trial record keeping in e-copy and hard copy (as appropriate).
o Operates within the project and department parameters while ensuring compliance with applicable regulatory, internal and project-specific requirements.
o Provides support for clinical operations related activity.
o Assists with Document Control activities, QMS activities and other Clinical Operations department needs.
EDUCATION & EXPERIENCE
o Undergraduate degree, preferably in a science or business, preferred.
o Proficient in Microsoft Word, Excel, PowerPoint and experience using database software.
o Excellent written and oral communication skills.
o Excellent organizational skills and attention to detail.
o Strong interpersonal skills and the ability to work with deadlines and manage multiple priorities.

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