Clinical Trials Operations Specialist
4 weeks ago
This role is responsible for the management of the RadMD Blinded Reader & Investigator Training Institute (BRITI) and Reader management and qualification activities within the Reader Management Qualification System (RMQS).
Key Responsibilities:- Develop and deploy new BRITI training modules, manage revisions, and become an expert in the BRITI system.
- Lead User Acceptance Testing (UAT) for new modules, including stress testing and documentation.
- Educate the RadMD team on BRITI functionality, tools, and enhancements.
- Maintain and update existing BRITI training materials based on literature and FDA regulations.
- Maintain the library of all live BRITI training modules in the RadMD Document Management System.
- Propose improvements and enhancements for the BRITI platform by gathering user feedback and evaluating usage reports.
- Collaborate with BRITI developers and QA to implement and test new features.
- Support internal and external BRITI training sessions, including GCP training and onboarding.
- Manage the Reader Management Qualification System (RMQS), including creating and maintaining user accounts and documentation.
- Track verification processes and follow up with readers to complete the process.
- Collect and maintain required reader documentation, such as CVs and experience statements.
- Process Reader Management Qualification Forms and collaborate with RadMD Principals for reader selection.
- Prepare and maintain reader and client contracts, work orders, and amendments.
- Manage reader schedules and travel arrangements.
- Collaborate with the finance team to ensure reader billing is up-to-date.
- Oversee the annual renewal process, including documentation collection, FDA debarment checks, and financial disclosures.
- Ensure readers complete GCP renewal training every 2 years.
- Conduct quarterly process reviews and propose improvements for RMQS.
- Provide regular status updates and reports to the Director of Project Management.
- Lead training sessions and presentations as required.
- Competitive pay
- Medical, dental, vision, disability, life insurance, and additional supplemental plans
- Excellent communication and client/reader service skills
- Strong problem-solving abilities and comfort with complexity
- Knowledge of learning management systems
- Experience with clinical trial training programs
- Comfortable managing client/reader interactions on behalf of RadMD
- Proficient in Microsoft Word, Excel, Outlook, PowerPoint, and Project
- Minimum BA/BS (preferred but not required)
- At least 2 years of experience in the pharmaceutical, biotechnology, or medical device industry
- Advanced knowledge of Quality Management System principles and industry standards
- Familiarity with FDA/HIPAA and other global regulatory compliance guidelines
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