Institutional Review Board Analyst

2 weeks ago

Rancho Mirage, United States Eisenhower Health Full time
  • Job Objective: A brief overview of the position.
    • Provides administrative support for the Eisenhower Medical Center Institutional Review Board (IRB), FWA00001954, IRB00002040. This includes conducting preliminary research reviews and working with IRB members and researchers to monitor 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
      • N/A
  • Blood Borne Pathogens
      • Minimal/ No Potential
  • Qualifications
    • Education
        • Required: Bachelor's degree in Science, Health Care Administration, Public Administration, Business Administration or a related field
        • Preferred: Master's degree in related field
    • Licensure/Certification
        • Preferred: Certified IRB Professional (CIP) from PRIM&R, Certified Clinical Research Associate (CCRA) from ACRP or Certified Clinical Research Professional (CCRP) from SOCRA
    • Experience
        • Required: Two (2) years of experience working with an IRB or three (3) years of experience with clinical trials in research setting involving human subjects
        • Preferred: Experience with an electronic IRB system (IRBNet or OneAegis/IRB Manager); human subject research performed at an academic medical center
  • Essential Responsibilities
    • 1. Demonstrates compliance with Code of Conduct and compliance policies, and takes action to resolve compliance questions or concerns and report suspected violations.
      2. Provides support for the activities of the IRB.
      3. Evaluates submissions to the IRB electronic IRB system to assure completeness of the submission.
      4. Works with Investigator and research team to assure that the submission is complete and ready for IRB review.
      5. Conducts preliminary regulatory reviews.
      6. Assists IRB Administrator with preparations for monthly convened meeting
      7. Upholds Standard Operating Procedures for the IRB.
      8. Coordinates IRB services with Eisenhower Health system, outside researchers and project sponsors.
      9. Monitors studies for compliance with OHRP, FDA regulations and institutional policies and procedures.
      10. Identifies and reports program problems to IRB Administrator and Director of Research Administration.
      11. Assists in the implementation and tracking of program enhancements and service improvements.
      12. Participates in system modifications to continually improves the eIRB operations.
      13. Contributes to evaluation, development and modification of forms/documents to aid both IRB members and researchers in the review and submission process.
      14. Performs on-site internal audits of IRB procedures and records (FDA, OHRP, etc.).
      15. Upholds and adheres to policies and procedures to assure adequate subject protections, compliance with applicable regulations and guidelines, and to enhance research program and IRB committee operations.
      16. Remains current on relevant law, guidelines, and policies for human subject research protections and supports IRB members and research team members do the same.
      17. Promotes a culture of regulatory compliance through education, audits and other monitoring processing.
      18. Reports serious or continuing noncompliance with regulations to Director of Research Administration, IRB Administrator and IRB Co-Chairs.
      19. Performs other duties as assigned.

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