Clinical Research Systems Specialist

Iterative Health•Cambridge, NY

About The Position

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. 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.

Requirements

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

Nice To Haves

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.

Responsibilities

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.