Clinical Research Systems Specialist

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes.

We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology. By combining deep clinical trial expertise with cutting-edge AI, we connect sponsors' scientific ambitions with high-performing research teams that expedite and expand access to novel therapeutics for patients in need.

Today, Iterative Health is headquartered in Cambridge, Massachusetts, and New York City with 250+ employees world-wide.

A Clinical Research Systems Specialist at Iterative Health plays an important role in enabling our clinical research operations by ensuring the systems, study builds, and operational materials that support our trials are accurate, efficient, and ready for use by our teams and research sites.

In this role, you will support the development, maintenance, and quality assurance of clinical trial systems and administrative study materials, with a particular focus on Clinical Trial Management Systems (CTMS). You will partner closely with Clinical Operations, research sites, Regulatory, Finance, and other cross-functional teams to support successful study launch and execution.

This is an opportunity for someone with hands-on clinical research experience who enjoys working at the intersection of clinical operations, technology, data, and process improvement.

• Build and maintain studies within CTMS platforms, ensuring study configurations accurately reflect protocols, sponsor requirements, and internal operational standards.
• Support clinical research sites in the effective use of CTMS platforms, troubleshooting issues and helping ensure accurate and consistent study management.
• Partner with Clinical Research Specialists and research sites to support EHR prescreening workflows and management of Patient Findings Reports.
• Conduct quality control reviews and user acceptance testing (UAT) of study builds prior to launch, identifying and resolving discrepancies to ensure operational readiness.
• Read, interpret, and understand assigned clinical research protocols and translate study requirements into appropriate system configurations and workflows.
• Maintain databases, trackers, and other documentation used to monitor departmental activities, study builds, quality reviews, and operational deliverables.
• Provide quality control support to the Budget and Contract teams, helping ensure study information and documentation are accurate and aligned across systems and materials.
• Monitor quality trends and provide regular reporting to leadership, highlighting issues, risks, and opportunities for process improvement.
• Partner cross-functionally with Clinical Operations, Regulatory, Finance, and site teams to support study start-up, launch, and ongoing execution.
• Participate in project and study meetings as needed, providing systems and operational expertise to support effective decision-making.
• Identify opportunities to improve workflows, system utilization, documentation, and quality controls as the organization and clinical research network scale.
• Perform operational and administrative responsibilities in accordance with company policies, procedures, and applicable clinical research standards.
• Performs related duties as requested

• Associate degree or equivalent relevant experience
• Prior experience as a Clinical Research Coordinator (CRC) or in a comparable clinical research operations role.
• Experience working with CRIO, Real Time CTMS, or similar clinical research…