- Requisition ID
- 01 - Days
- HHRI IRB Compliance
- Shea Medical Center
- Position Type
- Regular Full-Time
- Physical Work Location and New Employee Orientation Location : Address
- 10290 N 92nd St
- Work Hours
- 8:30 AM - 5 PM
HonorHealth is a non-profit, local healthcare organization known for community service and outstanding medical quality. HonorHealth encompasses five acute care hospitals with approximately 11,500 employees and 4,500 volunteers, over 70 primary and specialty care practices, clinical research, medical education, an inpatient rehabilitation hospital, an Accountable Care Organization, two foundations, and extensive community services.
HonorHealth is a leader in medical innovation, talent and technology with a genuine commitment to your growth. The health system's vibrant careers take place in an environment filled with opportunity and respect because we see the HONOR in you.
Bachelor's Degree or 4 years' related experience in Health Care related field Required
2 years experience and thorough knowledge of existing and new government regulations pertaining to human subject protections Required
Medical Terminology Required
Coordinates all activities related to the Institutional Review Board and assures compliance with IRB guidelines and FDA regulations. In accordance with (45 CFR 46.101-409) the IRB Coordinator facilitates initial and continuing review of research protocols in compliance with policy, and state and federal regulations. Maintains all IRB documentation including all IRB applications, correspondence, continuing review requests, protocol deviations, and information required from the Principal Investigator. Audits compliance of policies and documentation requirements for the involvement of human participants in research. The IRB Coordinator has primary responsibility for the daily management of the IRB Office operations, processes, and activities in support of the Research Program. The IRB Coordinator also provides strong leadership in regulatory interpretation and implementation of all applicable regulations including but not limited to Department of Health and Human Services (DHHS) regulations: 45 CFR 46, and Food and Drug Administration (FDA) regulations: Title 21 Code of Federal Regulations. This includes initial determinations regarding expedited, exempt, or full board review, as well as human subject risk determinations. Supervises the Regulatory Project Assistant.
- Monitors and analyzes current and new regulations affecting human subject protections and research privacy requirements, State and Federal agencies. Develops and implements policy and procedures accordingly
- Independently coordinates/prepares monthly IRB committee meetings by developing agendas, minutes and review material for IRB members. Assembles IRB packets. Assigns reviewers. Attends meeting and transcribes minutes. Composes correspondence within time frame established by the Department of Health and Human Services (DHHS) and the FDA.
- Reviews and revises IRB policy and procedures to maintain national accreditation.
- Educates all IRB personnel, Principal Investigators, Study Coordinators, and staff as necessary.
- Audits clinical research studies to assure compliance with federal regulations. Reports non-compliance to Research Compliance Administrator (RCA) and Research Integrity Officer (RIO).
- Supervises maintenance of database of clinical trials. Retrieves data, compiles reports, and analyzes data.
- Maintains all research records/IRB records according to guidelines established by the Department of Health and Human Services, the Food and Drug Administration and Scottsdale Healthcare Policies (organization/filing/ and maintenance of study files). Acts as a liaison between the IRB and Federal authorities when required.
- Develops, maintains, and reviews IRB budget.
It is the policy of HonorHealth to provide equal opportunity in employment. Selection and employment of applicants will be made on the basis of their qualifications without regard to race, color, religion, creed, national origin, age, disability, sexual orientation, marital status, veteran status or any other legally protected status.
Please review the Equal Employment Opportunity poster.
Please review the Equal Employment Opportunity Poster.HonorHealth wants all interested and qualified candidates to apply for employment opportunities. If you are an applicant with a disability who is unable to use our online tools to search and apply for jobs, please contact us at EmploymentOffice@HonorHealth.com . Please indicate the specifics of the assistance needed. This option is reserved only for individuals with disabilities that are unable to use the online tools and is not intended for other purposes.