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 80+ global clinical research sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies.
Requirements
- Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication and protocol management.
- Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation to meet enrollment targets on assigned studies
- Schedule all patient research visits and procedures consistent with protocol requirements
- Conduct patient visits as outlined within each study protocol
- Dispense study medication, collect vital signs and perform ECGs
- Perform blood draws, process and ship specimens per study protocol and IATA regulations
- Ensure relevant study and subject specific information is entered into the CTMS system on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms.
- Act as point of contact for study participants
- Adhere to Research SOPs, Good Clinical Practices, and the study protocols
- Maintain ongoing communication with the CRO, sponsor, research participants, Site Manager and PI throughout course of the study
- Ensure all safety data is reviewed by the PI in a timely manner
- Maintain inventory of study equipment and supplies onsite at all times
- Participate actively in communication of status and results to management; contribute and implement ideas to improve site performance
- Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol. Meet requirements for data query resolution times and quality
- Schedule and prepare for monitor visits
- Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
- Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance
- Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy
Benefits
- Generous Paid Time Off
- 401k Matching
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
