This position supports clinical trial execution by coordinating site activities, maintaining regulatory compliance, and ensuring accurate data management. The specialist will deliver training on the pill cam procedure to clinical staff and oversee proper implementation at investigational sites, ensuring adherence to trial protocols.
Key Responsibilities
- Lead training and ongoing support for clinical sites using the pill cam system
- Act as primary administrator for the Interactive Web Response System (IWRS), managing randomization processes
- Coordinate study team meetings, prepare minutes, and ensure timely distribution
- Maintain essential trial documentation, including tracking tools, supply inventories, and user records
- Support setup and maintenance of clinical trial databases and data tracking systems
- Assist in the collection, verification, and shipment of case report forms and data queries
- Update and manage the study data control table and ensure accuracy across systems
- Review and approve monitoring reports through the Siebel platform
- Implement CTM software updates as required
- Oversee the archiving of study-related documents in compliance with regulatory standards
- Support site visits including qualification, initiation, monitoring, and closeout activities
- Ensure each study center is equipped with necessary materials and staff are trained to protocol-specific requirements
- Provide administrative support for clinical operations and data management teams, including shipment coordination and recordkeeping
Qualifications & Requirements
Candidates must have experience in clinical trial coordination, with a solid understanding of GCP, SOPs, FDA regulations, and ICH guidelines. Familiarity with IWRS administration, randomization workflows, and clinical data systems such as Siebel and CTM is essential. The role demands strong organizational skills, precision in documentation, and a commitment to patient safety and data integrity.
Applicants must be available for 28 hours per week and able to complete initial in-person training in New Haven, CT, before transitioning to remote work. Prior experience in site training, supply logistics, and regulatory documentation is required.
