Director, Institutional Review Board (IRB)
Director, Institutional Review Board (IRB)
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1 Vacancy
Job Description
Sanford Health is one of the largest and fastest-growing not-for-profit health systems in the United States. Were proud to offer many development and advancement opportunities to our nearly 50000 members of the Sanford Family who are dedicated to the work of health and healing across our broad footprint.
Work Shift:
8 Hours - Day Shifts (United States of America)Scheduled Weekly Hours:
40Union Position:
NoDepartment Details
Summary
The Director of the Institutional Review Board (IRB) has several duties that include the leadership and responsibility for the oversight administration and coordination of policies and procedures related to the protection of the rights and welfare of human subjects in research and to ensure compliance with all federal state and local regulations and applicable institutional policies as well as Accreditation of Human Research Protection Programs (AAHRPP). Direct both the administrative and educational components of the IRB. Direct the human subject research protection program.Job Description
Delegate tasks and have strategic plans for the flow of work. Establish evaluate and oversee the administrative operations policies and procedures of the (3) Institutional Review Boards. Coordinate problems issues and decisions with IRB leadership staff and board members research investigators Sanford Clinical Research team Sanford Compliance Office and Risk Management Office.
Advise Sanford Institutional Official (IO) regarding the needs of IRB operations upcoming regulatory requirements appropriateness of reliance on external IRBs policy changes and IRB membership. Provide ultimate oversight of IRB office personnel and human resources issues budget and the development of broad educational programs.
Determine business necessity and oversee Research IT during implementation and upgrades to IRB software in order to maintain IRB operations. Manage the interaction process between IRB and government auditors. Responsible for assessment of external IRB functions and IRB workflow decision making during potential merger opportunities. Responsible for leading initial and annual submission process for (AAHRPP) accreditation.
Qualifications
Bachelors degree required. Masters degree preferred.
Minimum of five years of related experience and a thorough knowledge of institutional Review Board (IRB) practices and relevant federal regulations and guidance is required.
Experience as an IRB member is highly desired as well as clinical experience. Training in a medical or allied health field is desired.
Administrative management (financial management and personnel management training and experience) is also desired. Other combination of relevant education and experience will be considered.
Knowledge and understanding with a variety of regulations from the Food and Drug Administration (FDA) Office for Human Research Protections (OSHP) Environmental Protection Agency (EPA) Health Insurance Portability and Accountability Act (HIPPA) and Defender of Justice (DOJ).
Certified IRB Professional (CIP) certification is required. Opportunity to earn certificate once in role.
Sanford is an EEO/AA Employer M/F/Disability/Vet.
If you are an individual with a disability and would like to request an accommodation for help with your online application please call 1- or send an email to
Required Experience:
Director
Employment Type
Full-Time
