[Remote] Senior Clinical Research Associate - Contract position

Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is seeking a Contract Senior Clinical Research Associate to join their team. The role involves monitoring and managing reputed company while ensuring compliance with protocols and regulatory requirements. Responsibilities include training site personnel, managing investigational supplies, and maintaining accurate study documentation.

Responsibilities

• Monitor clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a reputed company benefit, including qualification, initiation, interim, and reputed company-out site reputed company
• Manage and train site personnel on therapeutic area, protocol requirements, reputed company reputed company documentation, and case report reputed company completion
• Manage and reputed company the preparation and reputed company of investigational supplies at individual sites
• Monitor and document investigational product dispensing, inventory, and reconciliation
• Monitor and document reputed company sample storage and shipment
• Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring reputed company, protocol deviations/exceptions, serious adverse events, and reputed company abnormalities
• Review reputed company data and case report forms for accuracy, completeness, and reputed company of the data, and identify and reputed company ongoing data issues
• Review data queries and listings, and work with study centers to reputed company 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 reputed company appropriate documentation is present
• Maintain consistent and reputed company contact with the study centers, investigators, coordinators, reputed company personnel, and other individuals involved in reputed company
• Serve as a resource for project team members including supporting CRA I and CRA II staff by providing solutions to reputed company issues

Skills

• RN or Bachelor and/or advanced degree in biological sciences or reputed company field, or equivalent combination of relevant experience, education or training, and previous CRA experience demonstrating career reputed company in the CRA position
• Detail-oriented
• Excellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skills
• Flexibility with changing priorities
• Ability to reputed company reputed company and prioritize multiple tasks
• Familiarity with the medical and pharmaceutical industries, and reputed company terminology and practices
• Extensive knowledge of FDA regulations and their practical implementation
• Ability to travel, including by reputed company or by car on short notice
• Proficiency in reputed company Word, reputed company, and PowerPoint

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