What are the responsibilities and job description for the Institutional Review Board (IRB) Administrator position at Cherokee Nation?
Job Summary
GENERAL DESCRIPTION
The Institutional Review Board (IRB) Administrator is responsible for reviewing ad assessing research involving human subjects. Their primary responsibility is assuring that appropriate steps are taken to protect the rights and welfare of people participating in research studies by assessing the ethics of the research and its methods. The IRB Administrator will fully promote informed and voluntary participation and seek to maximize the safety of subjects.
Job Duties
ESSENTIAL DUTIES AND RESPONSIBILITIES
· Responsible for overseeing day-to-day operations of the Cherokee Nations IRB, ensuring that research involving human subjects is conducted ethically.
· Provides guidance to researchers regarding protecting participant rights and welfare by assuring the accuracy of submissions and modifications; responds to investigators regarding deficiencies, inconsistencies or concerns.
· Responsible for the automation of the CNIRB review and oversight processes by implementing appropriate software.
· Communicate with the Cherokee Nation Directors of Health Services, Public Health, Education, Language, and Community Outreach Departments to identify individuals who may have the appropriate skills and knowledge to assist with efforts.
· The IRB Administrator will assist in identifying community members interested in participating in the Cherokee Nation IRB meetings.
· Some occasional travel is required, including travel for training, professional development, and meetings.
· Maintain working knowledge of applicable legal requirements and regulatory agency guidance (e.g. Federal regulations, FDA, ICH/GCP, OHRP guidance, state and local laws, HIPAA, and ethical principles) related to the protection of the rights and welfare of human subjects.
· Ensure compliance with all relevant regulations and guidelines by reviewing and assessing proposed research documentation, plans and consent forms, and providing written feedback, conducting continuous reviews of ongoing trials.
· Maintains accurate records, including database management and aids in the performance of internal quality improvement activities.
· Performs related duties as required.
LEVEL OF RESPONSIBILITY
· No supervisory responsibility.
· Sets work procedures, priorities, levels of responsibility and objectives.
· Possesses comprehensive knowledge of subject matter.
Qualifications
QUALIFICATIONS
· Master's degree in Biological Science, Public health, and/or Social Sciences is preferred; or nine (9) years of related experience; or an equivalent combination of education and experience.
· At least one (1) year of experience in human subject regulatory compliance or at least three (3) years combination of education and experience in human subject regulatory compliance and Biological Science, Public Health, and/or Social Sciences field of studies.
COMPETENCIES
· Relevant regulatory acuity
· Experience with IRB Manager
· Experience with IRB Net Electronic
· Practical and Pragmatic reasoning
· Experience with IRB Record Management Systems
· Excellent written and verbal communication
· Moral Reasoning
Physical Requirements
While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel and talk or hear. The employee is occasionally required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
CERTIFICATES, LICENSES, REGISTRATIONS
· Certified IRB Professional (CIP) required within 12 months of hire date.
· Valid Driver's License with a driving history verified through a motor vehicle report that meets requirements for Cherokee Nation underwriting rating.
Other Requirements
The employee must not be and will not be under sanction by the United States Department of Health and Human Services Office of the Inspector General (OIG) or by the General Services Administration (GSA) or listed on the OIG's Cumulative Sanction Report, or the GSA's List of Excluded Providers, or listed on the OIG's List of Excluded Individuals/Entities (LEIE).
If you would like to schedule time to speak with a HR Recruiter to discuss your application/resume, please click, book time with the HR Recruiter.
GENERAL DESCRIPTION
The Institutional Review Board (IRB) Administrator is responsible for reviewing ad assessing research involving human subjects. Their primary responsibility is assuring that appropriate steps are taken to protect the rights and welfare of people participating in research studies by assessing the ethics of the research and its methods. The IRB Administrator will fully promote informed and voluntary participation and seek to maximize the safety of subjects.
Job Duties
ESSENTIAL DUTIES AND RESPONSIBILITIES
· Responsible for overseeing day-to-day operations of the Cherokee Nations IRB, ensuring that research involving human subjects is conducted ethically.
· Provides guidance to researchers regarding protecting participant rights and welfare by assuring the accuracy of submissions and modifications; responds to investigators regarding deficiencies, inconsistencies or concerns.
· Responsible for the automation of the CNIRB review and oversight processes by implementing appropriate software.
· Communicate with the Cherokee Nation Directors of Health Services, Public Health, Education, Language, and Community Outreach Departments to identify individuals who may have the appropriate skills and knowledge to assist with efforts.
· The IRB Administrator will assist in identifying community members interested in participating in the Cherokee Nation IRB meetings.
· Some occasional travel is required, including travel for training, professional development, and meetings.
· Maintain working knowledge of applicable legal requirements and regulatory agency guidance (e.g. Federal regulations, FDA, ICH/GCP, OHRP guidance, state and local laws, HIPAA, and ethical principles) related to the protection of the rights and welfare of human subjects.
· Ensure compliance with all relevant regulations and guidelines by reviewing and assessing proposed research documentation, plans and consent forms, and providing written feedback, conducting continuous reviews of ongoing trials.
· Maintains accurate records, including database management and aids in the performance of internal quality improvement activities.
· Performs related duties as required.
LEVEL OF RESPONSIBILITY
· No supervisory responsibility.
· Sets work procedures, priorities, levels of responsibility and objectives.
· Possesses comprehensive knowledge of subject matter.
Qualifications
QUALIFICATIONS
· Master's degree in Biological Science, Public health, and/or Social Sciences is preferred; or nine (9) years of related experience; or an equivalent combination of education and experience.
· At least one (1) year of experience in human subject regulatory compliance or at least three (3) years combination of education and experience in human subject regulatory compliance and Biological Science, Public Health, and/or Social Sciences field of studies.
COMPETENCIES
· Relevant regulatory acuity
· Experience with IRB Manager
· Experience with IRB Net Electronic
· Practical and Pragmatic reasoning
· Experience with IRB Record Management Systems
· Excellent written and verbal communication
· Moral Reasoning
Physical Requirements
While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel and talk or hear. The employee is occasionally required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
CERTIFICATES, LICENSES, REGISTRATIONS
· Certified IRB Professional (CIP) required within 12 months of hire date.
· Valid Driver's License with a driving history verified through a motor vehicle report that meets requirements for Cherokee Nation underwriting rating.
Other Requirements
The employee must not be and will not be under sanction by the United States Department of Health and Human Services Office of the Inspector General (OIG) or by the General Services Administration (GSA) or listed on the OIG's Cumulative Sanction Report, or the GSA's List of Excluded Providers, or listed on the OIG's List of Excluded Individuals/Entities (LEIE).
If you would like to schedule time to speak with a HR Recruiter to discuss your application/resume, please click, book time with the HR Recruiter.
