group
Category
Specialists (Clinical and Non-Clinical)
business
Department
Research Admin
date_range
Schedule
Full Time
schedule
Shift
Day
timer
Hours
8 Hour Shift
place
Location
Rancho Mirage, CA 92270
info
Job #
R0255696
  • Job Objective: A brief overview of the position.
    • The primary purpose of this position is to run daily operations, while providing oversight and strategic planning for the Eisenhower Medical Center Institutional Review Board (IRB), FWA00001954, IRB00002040.  This includes facilitating the research review and approval process with IRB members and researchers to ensure institutional compliance with federal and state laws, regulations, institutional policies and guidelines governing human research protections.
  • Reports to
    • Director, Research Administration
  • Supervises
    • N/A
  • Ages of Patients
    • Adults
  • Blood Borne Pathogens
    • Minimal/ No Potential
  • Qualifications
    • Education
      • Preferred: A Bachelor’s degree from a college or university in Science, Health Care Administration, Public Administration, Business Administration or a related field
      • Preferred: Graduate degree
    • Licensure/Certification
      • Required: Certified IRB Professional (CIP) from www.primr.org upon eligibility
      • Preferred: Certified IRB Professional (CIP) from www.primr.org
    • Experience
      • Required: 5 years of administrative experience working with an IRB or within a research setting involving human subjects
      • Preferred: 8 years of experience working with an IRB or within a research setting involving human subjects
  • Essential Responsibilities
    • Demonstrates compliance with Code of Conduct and compliance policies, and takes action to resolve compliance questions or concerns and report suspected violations.
    • Manage the activities of the IRB.
    • Develop, maintain and update Standard Operating Procedures for the IRB.
    • Conduct all aspects of the monthly IRB meeting.
    • As needed, conduct weekly status meetings with IRB co-chair and Director of the Clinical Trials Office.
    • Coordinate IRB services with Eisenhower Health system, outside researchers and project sponsors.
    • Identify program problems, determine appropriate action and make recommendations for problem resolution; assist in the implementation of program enhancements and service improvements.
    • Define reporting and information needs and provide supporting products Coordinate systems modifications to continually refine the eIRB tool; coordinate the efforts of administrative, technical, and IT support to the IRB.
    • Evaluate, develop and modify forms/documents to aid both committee members and researchers in the review and submission process.
    • Prepare and present a variety of informational reports and make recommendations in writing, graphic and oral presentations.
    • On-site audits of IRB procedures and records (FDA, OHRP, etc.).
    • Develop, recommend and implement policies and procedures to assure adequate subject protections, compliance with applicable regulations and guidelines, and to enhance research program and IRB committee operations.
    • Understand and remain current on relevant law, guidelines, and policies for human subject research protections and ensure the IRB members and research team members do the same.
    • Participate in ongoing continuing education to keep current with new developments and laws; Analyze and interpret existing, new and proposed regulations for program impacts.
    • Develop a culture of regulatory compliance through training, education, audits and other monitoring processing.
    • Ensure timely, accurate and efficient processing of study documentation and appropriate management of data systems (share folders and eIRB).
    • Advise and guide researchers on the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), and the Department of Health and Human Services (DHHS) and IRB regulations, policies, procedures, and guidelines.
    • Ability to Interpret legislation, regulations, policies, procedures and ethical principles in research compliance.
    • Ability to administer, coordinate and supervise the work of an assigned staff engaged in complex analytical or administrative programs.
    • Report serious or continuing noncompliance with regulations and suspension or termination of IRB approval to institutional officials and others, as required.
    • Performs other duties as assigned.