Senior Clinical Research Associate

3 days ago

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ProTrials Research Inc.

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Experienced Professionals, Trusted Partners Worldwide

CRO management services • Clinical Monitoring • Clinical Project Management • Clinical Site Management • Clinical Study Start-up

51 - 200

Description

Monitor clinical studies of investigational and approved products • Manage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion • Manage and track the preparation and return of investigational supplies at individual sites • Monitor and document investigational product dispensing, inventory, and reconciliation • Monitor and document laboratory sample storage and shipment • Monitor trial by reviewing and reporting on site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities • Review source data and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issues • Review data queries and listings, and work with study centers to resolve data discrepancies • Review regulatory documentation for accuracy and completeness, and support study centers with regulatory issues • Maintain complete and accurate study files and review files to ensure all appropriate documentation is present • Maintain consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials • Serve as a resource for project team members including supporting CRA I and CRA II staff by providing solutions to resolve issues

Requirements

Detail-oriented • Excellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skills • Flexibility with changing priorities • Ability to efficiently perform and prioritize multiple tasks • Familiarity with the medical and pharmaceutical industries, and related terminology and practices • Extensive knowledge of FDA regulations and their practical implementation • Ability to travel, including by air or by car on short notice • Computer proficiency in Microsoft Word, Excel, and PowerPoint

Benefits

Competitive pay • Career growth • Full medical, dental, and vision benefit packages • 401(k) with match • Commuter benefits • Legal benefits • The best coworkers, if we do say so ourselves