Clinical Research Coordinator II

divh2Clinical Research Coordinator II/h2pIterative 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./ppWe 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./ppstrongResponsibilities:/strong/pulliAdministratively and clinically manage industry-sponsored clinical trials including problem solving, communication and protocol management. Manage a full schedule of complex study visits and corresponding tasks with minimal direction./liliLead 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, with accountability for achieving enrollment goals/liliSchedule all patient research visits and procedures consistent with protocol requirements/liliConduct patient visits as outlined within each study protocol/liliDispense study medication, collect vital signs and perform ECGs/liliPerform blood draws, process and ship specimens per study protocol and IATA regulations/liliEnsure 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. Maintain high quality data entry within established timelines/liliAct as point of contact for study participants/liliAdhere to Research SOPs, Good Clinical Practices, and the study protocols/liliMaintain ongoing communication with the CRO, sponsor, research participants, Site Manager, central Iterative Health team, and PI throughout the study. Resolve routine sponsor and CRO issues independently/liliEnsure all safety data is reviewed by the PI in a timely manner/liliMaintain inventory of study equipment and supplies onsite at all times/liliContribute to status updates to management; contribute and implement ideas to improve site performance/liliAssist 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./liliSchedule and prepare for monitor visits/liliAssists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations/liliCooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance/liliComplete and maintain case report forms per FDA guidelines, and review them against the patients medical record for completeness and accuracy/li/ulpstrongIterative Health Expectations/strong/ppAll employees are expected to:/pulliPerform quality work within deadlines with or without direct supervision/liliInteract professionally with other employees, customers and suppliers/liliWork effectively as a team contributor on all assignments/liliWork independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations/li/ulpstrongQualifications/strong/pulliMedical Assistant, LPN, Associates or Bachelors degree in a clinical or scientific-related discipline preferred/liliMinimum 3 years of clinical research experience/liliAbility to own issues and problem solve independently/liliExperience in phlebotomy preferred/liliStrong written and verbal communication skills/liliAbility to read, interpret, and apply clinic policies and research protocols/liliAbility to use standard office software/liliMust be able to lift up to 25 pounds/li/ulpAt Iterative Health, were 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./p/div