Clinical Trials Regulatory Coordinator - Urology

Description Under the direct supervision of the Clinical Trials Administrator, The Regulatory Coordinator is responsible for submitting and managing all regulatory documentation for the Institute of Urologic Oncology's clinical research portfolio according to institutional and federal guidelines. Key duties include submitting applications to the FDA, IRB, ISPRC, DSMB, ancillary departments, and other applicable review committees (including at start-up, for all amendments, and at continuing review); maintaining communication with aforementioned regulatory bodies; developing informed consent forms; and maintaining regulatory files in paper and electronic form. The incumbent recognizes and performs necessary tasks to manage projects and prioritizes work to meet necessary deadlines. The incumbent is responsible for planning and organizing necessary tasks to ensure adherence to the study protocol and applicable regulations, such as institutional policy and procedures, FDA Code of Federal Regulations (CFR), and ICH Good Clinical Practice (GCP). The Clinical Research Coordinator collaborates with the Principal Investigator (PI), ancillary departments, central research infrastructure teams, sponsors, institutions, and other entities as needed to support the administration of all aspects of studies, including, but not limited to, compliant conduct, financial management, and adequate personnel support. The full hourly salary range for this position is $ 31.51 - $62.64. Please note that the department's target hourly pay is $31.51. Qualifications Required: Minimum of 1+ years of experience as a clinical researcher. Interpersonal skills to effectively communicate information in a timely, professional manner and establish and maintain cooperative and effective working relationships with students, staff, faculty, external collaborators and administration and to work as a member of a team. Ability to set priorities and complete ongoing tasks with competing deadlines, with frequent interruptions, to meet the programmatic and department needs, while complying with applicable University policies and federal and state regulations. Analytical skills to assess clinical research protocols and regulatory requirements, define problems, formulate logical solutions, develop alternative solutions, make recommendations, and initiate corrective actions. Close attention to detail to ensure accuracy in a fast-paced, fluctuating workload environment. Organization skills to create and maintain administrative and regulatory files effectively as well as independently balance the various tasks to ensure deadlines are met. Demonstrated proficiency with Adobe and Microsoft suite software, especially Excel, to perform daily tasks efficiently and accurately. A learning and professional growth mentality so that new software tools, systems, and processes can be adopted quickly and efficiently. Working knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws. Knowledge of and experience working with a variety of local and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and foundation funding organizations, etc. #J-18808-Ljbffr