Clinical Research Systems Specialist
<div class="content-intro"><p><span style="font-size: 10pt;">Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes.</span></p>
<p><span style="font-size: 10pt;">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.</span></p>
<p> </p></div><p><span style="font-size: 10pt;">A <strong>Clinical Research Systems Specialist </strong>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.</span></p>
<p><span style="font-size: 10pt;">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.</span></p>
<p><span style="font-size: 10pt;">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.</span></p>
<p><span style="font-size: 10pt;"><strong>Where You’ll Drive Impact </strong></span></p>
<ul>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Build and maintain studies within CTMS platforms, ensuring study configurations accurately reflect protocols, sponsor requirements, and internal operational standards.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Support clinical research sites in the effective use of CTMS platforms, troubleshooting issues and helping ensure accurate and consistent study management.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Partner with Clinical Research Specialists and research sites to support EHR prescreening workflows and management of Patient Findings Reports.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Conduct quality control reviews and user acceptance testing (UAT) of study builds prior to launch, identifying and resolving discrepancies to ensure operational readiness.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Read, interpret, and understand assigned clinical research protocols and translate study requirements into appropriate system configurations and workflows.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Maintain databases, trackers, and other documentation used to monitor departmental activities, study builds, quality reviews, and operational deliverables.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Provide quality control support to the Budget and Contract teams, helping ensure study information and documentation are accurate and aligned across systems and materials.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Monitor quality trends and provide regular reporting to leadership, highlighting issues, risks, and opportunities for process improvement.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Partner cross-functionally with Clinical Operations, Regulatory, Finance, and site teams to support study start-up, launch, and ongoing execution.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Participate in project and study meetings as needed, providing systems and operational expertise to support effective decision-making.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Identify opportunities to improve workflows, system utilization, documentation, and quality controls as the organization and clinical research network scale.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Perform operational and administrative responsibilities in accordance with company policies, procedures, and applicable clinical research standards.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Performs related duties as requested </span></li>
</ul>
<p><span style="font-size: 10pt;"><strong>What You Bring to the Team </strong></span></p>
<ul>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Associate degree or equivalent relevant experience </span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Prior experience as a Clinical Research Coordinator (CRC) or in a comparable clinical research operations role.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Experience working with CRIO, RealTime CTMS, or similar clinical research technology platforms.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Strong understanding of clinical research workflows and the ability to read and interpret clinical trial protocols.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Exceptional attention to detail, with strong quality control and follow-through skills.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Ability to work with clinical and operational data in a confidential, accurate, and compliant manner.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Strong technology aptitude and the ability to quickly learn and navigate new systems and workflows.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Proficiency with tools such as Microsoft Office, including Excel, Word, PowerPoint, Outlook, and Teams, as well as Adobe and web-based applications.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Excellent time management, planning, and organizational skills with the ability to manage multiple priorities in a fast-paced environment.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Strong written and verbal communication skills and the ability to collaborate effectively across functions and levels.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">High degree of professionalism, judgment, integrity, and accountability.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Intellectual curiosity and a proactive, solutions-oriented approach to problem-solving.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Ability to thrive in a dynamic, evolving environment where processes and systems continue to scale.</span></li>
</ul>
<h3><span style="font-size: 10pt;"><strong>Preferred Qualifications</strong></span></h3>
<ul>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Experience working within a healthcare, clinical research, or technology start-up environment.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Experience reading and interpreting clinical research protocols, manuscripts, and supporting study documentation.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Experience supporting or managing external vendors.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Familiarity with ICH-GCP and Good Documentation Practice (GDP) guidelines.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Familiarity with clinical trial documentation, including study budgets, Clinical Trial Agreements (CTAs), eCRF guidelines, lab manuals, pharmacy manuals, informed consent forms, and annotated CRFs.</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Experience supporting study start-up activities, CTMS implementations, system configuration, or clinical research process improvement.</span></li>
</ul>
<p><span style="font-size: 10pt;"><strong>How We Work </strong></span></p>
<ul>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Collaborative and low-ego team environment</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">High ownership and accountability culture</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Fast-paced and highly iterative growth environment</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Open communication and continuous learning mindset</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Mission-driven organization focused on improving patient outcomes</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Comfortable navigating evolving business priorities and opportunities</span></li>
</ul>
<p><span style="font-size: 10pt;"><strong>Benefits That Support You </strong></span></p>
<p><span style="font-size: 10pt;">We believe great teams do their best work when they feel supported — professionally and personally.</span></p>
<ul>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Hybrid work environment with in-office collaboration two days per week in either our NYC or Boston office</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Comprehensive medical, dental, and vision coverage, with up to 80% of premiums covered by Iterative Health</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Mental health and wellness support through Spring Health</span></li>
<li style="font-size: 10pt;"><span style="font-size: 10pt;">Health HSA
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