What You'll Do
In this role, you will coordinate key aspects of clinical trial operations for the pill cam procedure, ensuring adherence to regulatory standards and internal protocols. You will deliver training and ongoing support to clinical site staff, helping them implement study procedures accurately and efficiently.
You will serve as the primary administrator for the Interactive Web Response System (IWRS), managing user access and system functionality. This includes supporting the randomization process and maintaining accurate records throughout the trial lifecycle.
Daily responsibilities include organizing and documenting study team meetings, maintaining comprehensive trial documentation, and overseeing the logistics of trial supplies such as colonoscopy forceps and shipping materials. You will ensure clinical databases and tracking tools are properly configured and updated, and assist in the management of case report forms and data queries.
You will also coordinate site visits for qualification, initiation, monitoring, and closeout, ensuring compliance with FDA regulations, ICH guidelines, and company SOPs. This includes verifying that each study center is properly equipped and that staff are trained to protocol-specific standards.
Requirements
- Availability to work 28 hours per week (70% of a standard work week)
- Ability to complete initial training onsite in New Haven, CT
- Proven experience supporting clinical trial logistics in compliance with GCP and SOPs
- Direct experience administering IWRS systems and managing user access
- Experience maintaining study documentation, data control tables, and inventory records
- Background in coordinating trial-related meetings and producing accurate minutes
- Familiarity with clinical trial databases, including Siebel, and tracking tools
- Experience handling shipment and tracking of CRFs and data queries
- Knowledge of CTM software updates and study archiving procedures
- Understanding of FDA regulations and ICH-GCP guidelines
- Commitment to patient safety and data integrity across all trial activities
- Experience conducting site management activities including staff training and site setup
Work Mode
This position begins with required onsite training in New Haven, CT. Following this phase, remote work is permitted. The role requires a consistent weekly commitment of 28 hours.
Technical Environment
You will work with established clinical systems including IWRS for randomization and trial management, Siebel for monitoring reports, and CTM for software updates and trial logistics.
