Allegheny Health Network
Job Description :
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
- 3 years recent IRB or clinical research coordinator experience
- CIM or CRC
- Certified IRB Professional (CIP)
- Certified IRB Manager
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