Clinical Research Systems Specialist
Iterative Health, Cambridge, MA, United States
Cambridge, Massachusetts, United States, New York, New York, United States
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, advancing the path to market for gastrointestinal (GI) and hepatology novel therapies. We combine deep expertise in clinical trials with cutting‑edge AI to empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
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.
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
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.
Compensation
New York pay range: $70,000 - $90,000 USD
We are an equal‑opportunity employer. As set forth in Iterative Health’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.
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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, advancing the path to market for gastrointestinal (GI) and hepatology novel therapies. We combine deep expertise in clinical trials with cutting‑edge AI to empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
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.
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
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.
Compensation
New York pay range: $70,000 - $90,000 USD
We are an equal‑opportunity employer. As set forth in Iterative Health’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.
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