Clinical Research Systems Specialist

Iterative Health is a healthcare technology and services company accelerating clinical research to improve patient outcomes. The Clinical Research Systems Specialist supports the development, maintenance, configuration, and quality assurance of clinical trial systems, particularly CTMS platforms, and related study materials. The role collaborates with Clinical Operations, research sites, Regulatory, Finance, and other teams to support study launch, execution, reporting, and process improvement.

Responsibilities

• 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

Preferred

• 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
• Healthcare experience
• Clinical research experience
• Technology start-up experience
• Reading clinical protocols
• Interpreting manuscripts
• Managing external vendors
• ICH-GCP
• Documentation Practice
• Clinical trial documentation
• Study budgets
• Clinical Trial Agreements
• eCRF guidelines
• Lab manuals
• Pharmacy manuals
• Informed consent forms
• Annotated CRFs
• Study start-up activities
• CTMS implementations
• System configuration
• Clinical research process improvement

Benefits

• 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

Company

• Clinical research technology and services for accelerating novel therapies
• Cambridge, Massachusetts, USA
• https://iterative.health/
• Founded in 2017
• 51-200 employees

Qualifications

• 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
• 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

Required skills

• Clinical Trial Management Systems (CTMS), Clinical Research Operations, Clinical Trial Protocol Interpretation, Quality Control, User Acceptance Testing (UAT), EHR Prescreening Workflows, Microsoft Office, Adobe, ICH-GCP, Documentation Practice (GDP), Clinical Trial Documentation, Clinical Research Process Improvement

Preferred skills

• Experience supporting or managing external vendors

Experience

• Mid level