Clinical Trials Regulatory Coordinator - Urology

Job Description

Description

Under the direct\nsupervision of the Clinical Trials Administrator, The Regulatory Coordinator is\nresponsible for submitting and managing all regulatory documentation for the\nInstitute of Urologic Oncology's clinical research portfolio according to\ninstitutional and federal guidelines. Key duties include submitting\napplications to the FDA, IRB, ISPRC, DSMB, ancillary departments, and other\napplicable review committees (including at start-up, for all amendments, and at\ncontinuing review); maintaining communication with aforementioned regulatory\nbodies; developing informed consent forms; and maintaining regulatory files in\npaper and electronic form. The incumbent recognizes and performs necessary\ntasks to manage projects and prioritizes work to meet necessary deadlines. The\nincumbent is responsible for planning and organizing necessary tasks to ensure\nadherence to the study protocol and applicable regulations, such as institutional\npolicy and procedures, FDA Code of Federal Regulations (CFR), and ICH Good\nClinical Practice (GCP). The Clinical Research Coordinator collaborates with\nthe Principal Investigator (PI), ancillary departments, central research\ninfrastructure teams, sponsors, institutions, and other entities as needed to\nsupport the administration of all aspects of studies, including, but not\nlimited to, compliant conduct, financial management, and adequate personnel\nsupport.

\nThe 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\nresearcher.
• Interpersonal skills to effectively communicate\ninformation in a timely, professional manner and establish and maintain\ncooperative and effective working relationships with students, staff, faculty,\nexternal collaborators and administration and to work as a member of a team.
• Ability to set priorities and complete ongoing\ntasks with competing deadlines, with frequent interruptions, to meet the\nprogrammatic and department needs, while complying with applicable University\npolicies and federal and state regulations.
• Analytical skills to assess clinical research\nprotocols and regulatory requirements, define problems, formulate logical\nsolutions, develop alternative solutions, make recommendations, and initiate\ncorrective actions.
• Close attention to detail to ensure accuracy in\na fast-paced, fluctuating workload environment.
• Organization skills to create and maintain\nadministrative and regulatory files effectively as well as independently\nbalance the various tasks to ensure deadlines are met.
• Demonstrated proficiency with Adobe and\nMicrosoft suite software, especially Excel, to perform daily tasks efficiently\nand accurately.
• A learning and professional growth mentality so\nthat new software tools, systems, and processes can be adopted quickly and\nefficiently.
• Working knowledge of clinical research concepts,\npolicies and procedures, and human safety protection regulations and\nlaws.
• Knowledge of and experience working with a\nvariety of local and external IRBs, scientific review and other research\ncommittees, national cooperative group sponsors, industry sponsors, federal and\nfoundation funding organizations, etc.