Allegheny Health Network
Job Description :GENERAL OVERVIEW:
Ensures compliance with federal regulations (FDA and NIH) throughout the review and approval process all research protocols involving human subjects.
Plans and manages all activities pertaining to the IRB review and approval process of all research protocols involving human subjects submitted by researchers. (20%)
Provides direction to researchers regarding protocol submission, correcting medical and technical deficiencies or protocols, informed consent documents, amendments, etc. (20%)
Reviews independently protocols submitted by researchers for exempt or expedited review based on clinical expertise/training. (20%)
Maintains the IRB database (RAPID). (20%)
Maintains compliance with all regulatory agencies, including institutional policy, procedures, guidelines, and federal regulations. (20%)
BA/BS in Health Sciences of related field
Certified IRB Professional (CIP)
Certified IRB Manager
3 years recent IRB or clinical research coordinator experience
CIM or CRC
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