Clinical Research Coordinator II - Nurse

Clinical Research Coordinator II - Nurse 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 70+ clinical research sites across US and Europe 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. We are seeking a full‑time, experienced Clinical Research Coordinator – LevelII (CRCII). 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, handling an increased number of studies or more complex studies. Lead patient recruitment activities, e.g., perform chart reviews, discuss protocols with patients, and verify 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 consent forms, source documentation, progress notes, 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 the 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. Assist Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations. Cooperate with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and report instances of non‑compliance. Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy. General 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. All employees are required to comply with the company's equal employment opportunity policy and to maintain a respectful and inclusive workplace. For accommodations during the application or interview process, contact View email address on click.appcast.io. #J-18808-Ljbffr