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. **Where You’ll Drive Impact** - 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 **What You Bring to the Team** - 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, RealTime CTMS, or similar clinical research technology platforms. - Strong understanding of clinical research workflows and the 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 the ability to quickly learn and navigate new systems and workflows. - Proficiency with tools such as Microsoft Office, including Excel, Word, PowerPoint, Outlook, and Teams, as well as Adobe and web-based applications. - Excellent time management, planning, and organizational skills with the ability to manage multiple priorities in a fast-paced environment. - Strong written and verbal communication skills and the ability to collaborate effectively across functions and levels. - High degree of professionalism, judgment, integrity, and accountability. - Intellectual curiosity and a proactive, solutions-oriented approach to problem-solving. - Ability to thrive in a dynamic, evolving environment where processes and systems continue to scale. ### **Preferred Qualifications** - Experience working within a healthcare, clinical research, or technology start-up environment. - Experience reading and interpreting clinical research protocols, manuscripts, and supporting study documentation. - Experience supporting or managing external vendors. - Familiarity with ICH-GCP and Good Documentation Practice (GDP) guidelines. - Familiarity with clinical trial documentation, including study budgets, Clinical Trial Agreements (CTAs), eCRF guidelines, lab manuals, pharmacy manuals, informed consent forms, and annotated CRFs. - Experience supporting study start-up activities, CTMS implementations, system configuration, or clinical research process improvement. **How We Work** - Collaborative and low-ego team environment - High ownership and accountability culture - Fast-paced and highly iterative growth environment - Open communication and continuous learning mindset - Mission-driven organization focused on improving patient outcomes - Comfortable navigating evolving business priorities and opportunities **Benefits That Support You** We believe great teams do their best work when they feel supported — professionally and personally. - Hybrid work environment with in-office collaboration two days per week in either our NYC or Boston office - Comprehensive medical, dental, and vision coverage, with up to 80% of premiums covered by Iterative Health - Mental health and wellness support through Spring Health - Health HSA or FSA options, and commuter FSA contributions supported by Iterative Health - Unlimited PTO, 12 company holidays, and a company-wide shutdown between Christmas and New Years - 401(k) program with a company match of up to 3% (up to $3,000 annually) - Weekly in-office lunch benefit every Tuesday - 100% company-paid short-term and long-term disability coverage - Annual wellness and professional development stipend to support your health and growth - And more! New York pay range $23—$40 USD At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact .