Provide comprehensive training and ongoing support to clinical sites using the pill cam system, ensuring staff are fully prepared to carry out procedures according to protocol. Serve as the primary administrator for the IWRS platform, overseeing randomization processes and maintaining system accuracy throughout the trial lifecycle.
What You'll Do
Lead the coordination of study team meetings by scheduling sessions, capturing detailed minutes, and distributing action items. Manage essential trial supplies, including colonoscopy forceps and shipping materials, while maintaining accurate inventory records. Ensure all study documentation is properly organized and archived in compliance with regulatory standards.
Support end-to-end logistics for clinical trials, following GCP and internal SOPs. Set up and maintain clinical trial databases and tracking tools to ensure data consistency. Assist in the collection, tracking, and shipment of case report forms and data queries to the data management team. Maintain the study data control table to support audit readiness and data transparency.
Conduct site qualification, initiation, monitoring, and closeout visits across multiple locations, ensuring adherence to FDA regulations and ICH guidelines. Verify that each study center receives required materials and that staff are trained to trial-specific standards. Review and approve monitoring reports through Siebel, and support updates to CTM software as needed.
Requirements
- Proven experience as an IWRS administrator and supporting randomization workflows
- Hands-on experience with clinical trial logistics, documentation management, and supply coordination
- Familiarity with Siebel and CTM software systems
- Strong understanding of GCP, FDA regulations, and ICH guidelines
- Experience conducting on-site visits and ensuring regulatory compliance
- Background in maintaining data integrity and supporting data management teams
- Ability to train clinical staff and manage site performance
- Administrative experience with shipment tracking, training records, and inventory control
Work Mode
This position begins with a three-month onsite training period, after which remote work is permitted. Candidates must be available for initial in-person onboarding and periodic site visits as required.
