Clinical Trials Regulatory Coordinator - Urology

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.

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.