IRB Program Specialist

Hello humankindness Located conveniently in the heart of Phoenix, Arizona,St. Joseph's Hospital and Medical Center is a 571-bed, not-for-profit hospital that provides a wide range of health, social and support services. Founded in 1895 by the Sisters of Mercy, St. Joseph's was the first hospital in the Phoenix area. More than 125 years later, St. Joseph's remains dedicated to its mission of caring for the poor and underserved. We are extremely proud to be a nationally recognized center for quality quaternary care, medical education and research. St. Joseph's includes the internationally renowned Barrow Neurological Institute, Norton Thoracic Institute, Cancer Center at St. Joseph's, Ivy Brain Tumor Center, and St. Joseph's Level I Trauma Center (which is verified by the American College of Surgeons). The hospital is also a respected center for high-risk obstetrics, neuro-rehabilitation, orthopedics, and other medical services. St. Joseph’s is considered a sought-after destination hospital for treating the most complex cases from throughout the world. Every day, approximately 20 percent of the hospital’s patients have traveled from outside of Arizona and the United States to seek treatment at St. Joseph’s. U.S News & World Report routinely ranks St. Joseph's among the top hospitals in the United States for neurology and neurosurgery. In addition, St. Joseph's boasts the Creighton University School of Medicine at St. Joseph's, and a strategic alliance with Phoenix Children's Hospital. St. Joseph's is consistently named an outstanding place to work and one of Arizona's healthiest employers. Come grow your career with one of Arizona's Most Admired Companies. Look for us on Facebook and follow us on Twitter. For the health of our community ... we are proud to be a tobacco-free campus.

Oversees the day-to-day operations of the Institutional Review Board (IRB) in accordance with all applicable institutional, state, federal and other regulatory requirements and guidelines. Requires subject matter expertise and demonstrated working knowledge of ICH, HHS, and FDA regulations pertaining to the ethical conduct of research. Responsibilities include daily operational guidance to all SJHMC/BNI investigators requiring independent judgement and strong critical thinking skills relative to human subject research regulations to ensure the safe and ethical conduct of research.

• Oversees all administrative functions of the Institutional Review Board (IRB) and provides support to the IRB Chairs and Members. Responsible for coordinating aspects of the IRB functions and activities, including scheduling and logistics for meetings, inspections and training sessions.
• Ensure proper compliance with institutional policies and procedures to ensure Dignity Health's compliance with Federal, State and local laws/regulations. Facilitates appropriate review for confirmation of scientific and statistical validity.
• Liaison between IRB Chair, IRB committee members, investigators, Research Program Managers, Accountable Executives, Administration, Legal department, Corporate Compliance departments, as well as government officials and institutional officials.
• Maintain in-depth knowledge of frequently changing federal regulations and guidelines, and other literature related to human subject protection.
• Support IRB and membership to assure efficient processing of communications.
• Support investigators and key study personnel in verifying completeness of IRB submissions.

Required

• Associates Other and/or equivalent combination of education and experience and Three to five years of related experience required upon hire and
• Experience in the area of biosafety, animal care and use, institutional ethics review, research administration, audit or otherarea of research, compliance or oversight.
• Bachelors Degree required

Preferred

• Five + years of related experience
• Clinical Research Associate
• Certified Clinical Research Coordinator ACRP
• Certified Clinical Rearch Coordinator SCRA