Senior Clinical Research Associate

Responsibilities

• Monitor clinical studies of investigational and approved products, including qualification, initiation, interim, and close-out site visits
• Manage and train site personnel on therapeutic area, protocol requirements, and documentation
• 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
• Review source data and case report forms for accuracy, completeness, and integrity
• Review data queries and listings to resolve data discrepancies
• Review regulatory documentation for accuracy and completeness
• Maintain complete and accurate study files
• Maintain consistent and timely contact with study centers, investigators, and client personnel
• Serve as a resource for project team members, including supporting CRA I and CRA II staff

Requirements

• RN or Bachelor/advanced degree in biological sciences or related field
• Previous CRA experience demonstrating career growth
• Extensive knowledge of FDA regulations and practical implementation
• Ability to travel up to 65%, including by air or car on short notice
• Proficiency in Microsoft Word, Excel, and PowerPoint
• Strong organizational, interpersonal, and problem-solving skills

About the Company

ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. We support research behind innovative treatments in the pharmaceutical, biotech, and medical device industries.