Clinical Research Systems Specialist

Iterative Health is pioneering the use of artificial intelligence-based precision medicine in cardiology, with the aim of helping to optimize clinical trials. Ultimately, the company aims to establish more meaningful endpoints to serve as better predictors of both therapeutic response and disease outcomes. This is an exciting time in the Clinical Research industry! Our team is driving the advancement of research by implementing streamlined processes, with a mission of getting treatment options to patients in a faster, more efficient way.

The Clinical Research Systems Specialist is responsible for supporting our clinical trial service operations through the development, maintenance, and quality assurance of administrative clinical trial materials.

What you’ll be doing:

• Perform and maintain study builds within CTMS system(s)
• Support clinical research sites within their CTMS
• Support Clinical Research Specialists & clinical research sites in EHR prescreening and management of Patient Findings Report
• Conduct quality review and user acceptance testing of study builds to ensure alignment with protocol, sponsor requirements, and internal standards
• Maintain databases/spreadsheets as necessary to facilitate tracking/documentation of departmental activities
• Provide QC support for budget and contract team
• Attend project meetings as needed
• Read and understand each assigned protocol
• Provide regular reports to advise leadership of quality issues and to guide process corrections & improvements
• Perform administrative duties in conformity with company policies and procedures
• Partner cross-functionally with clinical operations, regulatory, finance, and site teams to support study launch and execution.

Required Skills:

• Clinical Research Coordinator experience
• Experience with CRIO, RealTime CTMS or similar clinical research technology platforms
• Attention to detail and thorough follow-up skills
• Capable of handling and interacting with data in a confidential and compliant manner
• Ability to competently use and learn software such as internet browsers, Adobe, Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams) and clinical trial management system (CTMS)
• Intellectually curious
• Hardworking, forward-thinking, credible, conscientious, and creative
• Thrives when working within a high-paced, fluid environment
• Excellent time management, planning, and organizational skills are required
• Excellent written and verbal communication skills
• High level of tact, integrity, and professionalism

Preferred Qualifications:

• Experience within a healthcare start-up preferable
• Experience reading and understanding clinical research manuscripts and protocols
• Experience with vendor management
• Familiarity with ICH GCP/GDP guidelines
• Familiarity with the following study documents: Budgets, CTAs, eCRF guidelines, lab manuals, pharmacy manuals, informed consent forms, annotated CRFs, etc.