Iterative Health is focused on accelerating clinical research to bring gastrointestinal (GI) and hepatology novel therapies to market faster, by empowering clinical research sites with tech-enabled services and AI-driven solutions.
Requirements
- RN license required
- 1-3 years of Clinical Research Coordinating experience preferred
Responsibilities
- Communicate study requirements to all individuals involved in the study.
- Develop and implement recruitment strategies in accordance with GI Alliance RESEARCH and IRB requirements and approvals.
- Pre-screen and Screen subjects for eligibility using protocol specific inclusion and exclusion criteria.
- Entry of participant information and study visit procedures into the Clinical Trial Management System to ensure billing to appropriate funding sources.
- Maintains adequate inventory of study supplies. When handling investigational drugs/devices, follows the sponsor protocol and/or GI Alliance RESEARCH Policy on Investigational Drug/Device Accountability.
- Complete study documentation and maintenance of study files in accordance with sponsor requirements and GI Alliance RESEARCH policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
- Maintains effective and ongoing communication with sponsor, research participants, site manager, Regional Director, and PI during the course of the study.
Other
- Protects the rights and welfare of all human research participants involved in research in accordance with Federal regulations
- Cooperates with GI Alliance RESEARCH compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance to the appropriate compliance office
- Arranges secure storage of study documents that will be maintained according to Good Clinical Practice guidelines or for the contracted length of time, whichever is longer
- Collects and reports ongoing patient recruitment/ enrollment metrics to site manager and PI
- Manage the day to day activities of the study including problem solving, communication and protocol management.
