Clinical Trials Regulatory Coordinator – Urology | UCLA

Los Angeles, California, Description Under the directsupervision of the Clinical Trials Administrator, The Regulatory Coordinator isresponsible for submitting and managing all regulatory documentation for theInstitute of Urologic Oncology’s clinical research portfolio according toinstitutional and federal guidelines. Key duties include submittingapplications to the FDA, IRB, ISPRC, DSMB, ancillary departments, and otherapplicable review committees (including at start-up, for all amendments, and atcontinuing review); maintaining communication with aforementioned regulatorybodies; developing informed consent forms; and maintaining regulatory files inpaper and electronic form. The incumbent recognizes and performs necessarytasks to manage projects and prioritizes work to meet necessary deadlines. Theincumbent is responsible for planning and organizing necessary tasks to ensureadherence to the study protocol and applicable regulations, such as institutionalpolicy and procedures, FDA Code of Federal Regulations (CFR), and ICH GoodClinical Practice (GCP). The Clinical Research Coordinator collaborates withthe Principal Investigator (PI), ancillary departments, central researchinfrastructure teams, sponsors, institutions, and other entities as needed tosupport the administration of all aspects of studies, including, but notlimited to, compliant conduct, financial management, and adequate personnelsupport. 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 clinicalresearcher. Interpersonal skills to effectively communicateinformation in a timely, professional manner and establish and maintaincooperative 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 ongoingtasks with competing deadlines, with frequent interruptions, to meet theprogrammatic and department needs, while complying with applicable Universitypolicies and federal and state regulations. Analytical skills to assess clinical researchprotocols and regulatory requirements, define problems, formulate logicalsolutions, develop alternative solutions, make recommendations, and initiatecorrective actions. Close attention to detail to ensure accuracy ina fast-paced, fluctuating workload environment. Organization skills to create and maintainadministrative and regulatory files effectively as well as independentlybalance the various tasks to ensure deadlines are met. Demonstrated proficiency with Adobe andMicrosoft suite software, especially Excel, to perform daily tasks efficientlyand accurately. A learning and professional growth mentality sothat new software tools, systems, and processes can be adopted quickly andefficiently. Working knowledge of clinical research concepts,policies and procedures, and human safety protection regulations andlaws.  Knowledge of and experience working with avariety of local and external IRBs, scientific review and other researchcommittees, national cooperative group sponsors, industry sponsors, federal andfoundation funding organizations, etc.