Clinical Research Coordinator II - Nurse

Clinical Research Coordinator II - NurseIterative 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. 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.We are seeking a full-time, experienced Clinical Research Coordinator - Level II (CRC II). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.Responsibilities:Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication and protocol management. Able to manage an increased number of studies and/or more complex studiesLead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation to meet enrollment targets on assigned studiesSchedule all patient research visits and procedures consistent with protocol requirementsConduct patient visits as outlined within each study protocolDispense study medication, collect vital signs and perform ECGsPerform blood draws, process and ship specimens per study protocol and IATA regulationsIf assigned, place IVs, administer IV medication, and fluids according to protocol. Monitor patients' IV medications and tubing. Give intramuscular and subcutaneous injections according to protocol. Monitor patients during infusion and discharge patients as policies indicate.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 participantsAdhere to Research SOPs, Good Clinical Practices, and the study protocolsMaintain ongoing communication with the CRO, sponsor, research participants, Site Manager and PI throughout course of the studyEnsure all safety data is reviewed by the PI in a timely mannerMaintain inventory of study equipment and supplies onsite at all timesParticipate actively in communication of status and results to management; contribute and implement ideas to improve site performanceAssist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol. Meet requirements for data query resolution times and qualitySchedule and prepare for monitor visitsAssists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulationsCooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncomplianceComplete and maintain case report forms per FDA guidelines, and review them against the patient's medical record for completeness and accuracyIterative Health ExpectationsPerform quality work within deadlines with or without direct supervisionInteract professionally with other employees, customers and suppliersWork effectively as a team contributor on all assignmentsWork independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizationsQualificationsRegistered NurseSolid nursing background, concentration, or willingness to obtain advanced knowledge in GI specialtyMinimum 3 years of clinical research experienceAbility to own issues and problem solve independentlyExperience in phlebotomy preferredStrong written and verbal communication skillsAbility to read, interpret, and apply clinic policies and research protocolsAbility to use standard office softwareMust be able to lift up to 25 poundsAt Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact View email address on click.appcast.io.