Clinical Research Coordinator II

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 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies. 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. Clinical Research Coordinator II - Nurse 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 studies 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 If 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 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 Employee Expectations Perform quality work within deadlines with or without direct supervision Interact professionally with other employees, customers and suppliers Work effectively as a team contributor on all assignments Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations Qualifications Registered Nurse Solid nursing background, concentration, or willingness to obtain advanced knowledge in GI specialty Minimum 3 years of clinical research experience Ability to own issues and problem solve independently Experience in phlebotomy preferred Strong written and verbal communication skills Ability to read, interpret, and apply clinic policies and research protocols Ability to use standard office software Must be able to lift up to 25 pounds Iterative Health is committed to equal employment opportunity and welcomes applicants from all backgrounds. Please contact View email address on click.appcast.io for any accommodations needed to ensure an accessible application experience. #J-18808-Ljbffr Iterative Health