Research Integrity Specialist

Highmark Health - Pittsburgh, PA3.2

Full-time
Company :
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.

ESSENTIAL RESPONSIBILITIES:
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%)

QUALIFICATIONS:
Minimum

BA/BS in Health Sciences of related field
Certified IRB Professional (CIP)
Certified IRB Manager
3 years recent IRB or clinical research coordinator experience
Preferred

CIM or CRC
-

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