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IRT Coordinator

3 hours, 3 minutes ago
India
Full-time
Junior
Customer Support
Project and Program Management
Apply Now
Alimentiv

Alimentiv

Alimentiv specializes in providing comprehensive clinical research services for gastrointestinal and liver diseases, leveraging a global site network, advanced medical imaging, and biomarker discovery to enhance patient recruitment and accelerate clini...

Professional Services
251-1K
Founded 1986
View All Jobs 28

Description

  • Support execution of core IRT management activities across assigned clinical projects.
  • Prepare IRT documentation for trial start-up and maintenance phases.
  • Draft IRT User Guides, test scripts, and other study-specific documents using standard templates.
  • Assist with database testing and User Acceptance Testing (UAT) to verify system functionality and accuracy.
  • Support trial drug inventory management and ordering as needed.
  • Generate report requests, review outputs, and ensure report accuracy and relevance.
  • Create and deliver data transfers in line with study requirements.
  • Maintain approved study documentation in the electronic Trial Master File (eTMF).
  • Perform administrative trial support, including document distribution, internal communications, and eTMF submissions.
  • Coordinate client and internal meetings and provide user support to internal teams and customers.
  • Troubleshoot, triage, and escalate issues when required.
  • Contribute to process improvement, knowledge sharing, and cross-functional working groups within IRT and Data Management.

Requirements

  • Post-secondary diploma or certificate.
  • 1-3 years of related experience.
  • Fluent in reading, writing, and speaking English.
  • Basic understanding of clinical trial processes and protocols, including subject randomization, drug supply logistics, and data collection within IRT systems.
  • Knowledge of GxP, ICH-GCP, and regulatory requirements.
  • Experience collaborating cross-functionally with clinical operations, data management, supply chain, biostatistics, and sponsor teams.
  • Proficiency with IRT system documentation such as User Requirements Specifications (URS), UAT scripts, and validation records.
  • Strong project coordination skills, including timeline management, issue tracking, and vendor oversight.
  • Excellent written and verbal communication skills.
  • Working knowledge of clinical trial workflows, including randomization procedures, IP labeling and packaging, distribution coordination, and routine supply tracking.
  • Ability to support the management of unblinded study information under supervision.
  • Foundational experience with IRT systems, including data entry, standard reporting, and assisting with system updates.

Interested in this position?

Apply directly on the company website

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