Clinical Trials Operations Specialist

4 weeks ago


Conshohocken, Pennsylvania, United States RadMD Full time
Job Summary:

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.
What We Offer:
  • Competitive pay
  • Medical, dental, vision, disability, life insurance, and additional supplemental plans
Requirements:
  • 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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