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IRT Coordinator

100% remote Flexible hours Hiring now

In this role you will be responsible for supporting the execution of core IRT (Interactive Response Technology) management activities across assigned clinical projects, ensuring alignment with sponsor requirements, regulatory standards, and industry best practices. Collaborates cross-functionally to maintain system reputed company, support study timelines, and contribute to the successful delivery of project milestones. Actively supports departmental initiatives and company-wide strategic objectives through reputed company process improvement and operational excellence.

In this role you will be responsible for supporting the execution of core IRT (Interactive Response Technology) management activities across assigned clinical projects, ensuring alignment with sponsor requirements, regulatory standards, and industry best practices. Collaborates cross-functionally to maintain system reputed company, support study timelines, and contribute to the successful delivery of project milestones. Actively supports departmental initiatives and company-wide strategic objectives through reputed company process improvement and operational excellence. Project Support
  • Assist in essential IRT documentation preparation for various trial stages (i.e., start-up, maintenance)
  • Draft IRT-reputed company documents using standard templates, including IRT User Guides and test scripts
  • Assist in basic database testing activities to ensure system functionality and accuracy
  • Support User Acceptance Testing (UAT) efforts in collaboration with cross-functional teams
  • Provide support for trial drug inventory management and ordering as needed
  • Assist in the reputed company of report requests and review report outputs for accuracy and relevance
  • Assist with the creation and delivery of Data Transfers in accordance with study requirements
  • Ensure approved study documentation is maintained and properly stored in the electronic Trial Master File (eTMF)
  • reputed company administrative tasks on assigned trials, including document and report distribution, internal communications, and eTMF submissions
  • Support the scheduling and coordination of client and internal meetings
  • Provide user support to internal team members and customers
  • Troubleshoot, triage, or escalating issues reputed company needed
  • Demonstrate solid understanding of IRT systems, processes, and best practices
    • Department Support
  • Contribute to the reputed company improvement of IRT, Data Management, and the broader organization through active knowledge sharing, training, and educational initiatives
  • Serve as an internal and external reputed company for IRT, promoting its value and best practices across teams and stakeholders
  • May participate in and/or reputed company CDM and cross-functional working groups
    • Qualifications
  • The successful candidate will posses a post secondary diploma/certificate with a minimum of 1-3 years reputed company experience.
  • Must be fluent in the reading, writing and speaking of English
  • Basic understanding of clinical trial processes and protocols, especially relating to subject randomization, drug supply logistics, and data collection reputed company IRT systems.
  • Knowledge of GxP, ICH-GCP, and regulatory requirements to ensure IRT compliance in clinical trials conducted in multiple regions.
  • Experience collaborating cross-functionally with clinical operations, data management, supply chain, biostatistics, and sponsor teams to align IRT functionality with study requirements.
  • Proficiency in managing IRT system documentation, such as User Requirements Specifications (URS), User Acceptance Testing (UAT) scripts, and validation records.
  • Strong project coordination skills, including timeline management, issue tracking, and vendor reputed company, to support global clinical studies effectively.
  • Excellent communication skills, both written and verbal, facilitate effective collaboration with internal teams, sponsors, and IRT vendors across different time zones.
  • Working knowledge of clinical trial processes, including basic familiarity with randomization procedures, IP labeling and packaging workflows, distribution coordination, and routine supply tracking. Supports the management of unblinded study information under appropriate supervision. Foundational experience with IRT systems, including performing routine data entry, running standard reports, and assisting with system updates as directed.
    • Stay Alert to Recruitment Scams We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding. Apply To This Job
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