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Clinical Research Systems Specialist

Iterative Health - New York, NY, United States - Hybrid - posted 2026-09-09

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Salary: USD 23,000 - 40,000 / annual

Iterative Health is a healthcare technology and services company accelerating clinical research across gastrointestinal, hepatology, obesity, and cardiology. The company operates a network of 100+ research sites globally and combines clinical trial expertise with AI to connect sponsors with high-performing research teams. As a Clinical Research Systems Specialist, you will play a critical operational role in enabling clinical research by ensuring systems, study builds, and operational materials are accurate, efficient, and ready for use by internal teams and research sites. You will work at the intersection of clinical operations, technology, data, and process improvement. Key responsibilities include: - Build and maintain studies within Clinical Trial Management Systems (CTMS) platforms, ensuring configurations accurately reflect protocols and sponsor requirements - Support research sites in effective use of CTMS platforms, troubleshooting issues and ensuring accurate study management - Partner with Clinical Research Specialists and sites to support EHR prescreening workflows and Patient Findings Reports management - Conduct quality control reviews and user acceptance testing (UAT) of study builds prior to launch - Read, interpret, and translate clinical research protocols into appropriate system configurations and workflows - Maintain databases, trackers, and documentation for departmental activities, study builds, quality reviews, and operational deliverables - Provide quality control support to Budget and Contract teams to ensure study information alignment across systems - Monitor quality trends and provide regular reporting to leadership on issues, risks, and improvement opportunities - Partner cross-functionally with Clinical Operations, Regulatory, Finance, and site teams to support study start-up and execution - Identify opportunities to improve workflows, system utilization, and quality controls as the organization scales The role is hybrid with in-office collaboration two days per week in either the NYC or Boston office. REQUIREMENTS: - Associate degree or equivalent relevant experience - Prior experience as a Clinical Research Coordinator (CRC) or comparable clinical research operations role - Experience working with CRIO, RealTime CTMS, or similar clinical research technology platforms - Strong understanding of clinical research workflows and ability to read and interpret clinical trial protocols - Exceptional attention to detail with strong quality control and follow-through skills - Ability to work with clinical and operational data in a confidential, accurate, and compliant manner - Strong technology aptitude and ability to quickly learn new systems and workflows - Proficiency with Microsoft Office (Excel, Word, PowerPoint, Outlook, Teams), Adobe, and web-based applications - Excellent time management, planning, and organizational skills with ability to manage multiple priorities - Strong written and verbal communication skills and ability to collaborate across functions - High degree of professionalism, judgment, integrity, and accountability - Intellectual curiosity and proactive, solutions-oriented problem-solving approach - Ability to thrive in dynamic, evolving environments PREFERRED QUALIFICATIONS: - Experience in healthcare, clinical research, or technology start-up environments - Experience reading and interpreting clinical research protocols, manuscripts, and supporting documentation - Experience supporting or managing external vendors - Familiarity with ICH-GCP and Good Documentation Practice (GDP) guidelines - Familiarity with clinical trial documentation (budgets, CTAs, eCRFs, lab/pharmacy manuals, informed consent forms) - Experience supporting study start-up activities, CTMS implementations, system configuration, or clinical research process improvement

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