HRRP Reliance Specialist

Location:

Rosedale Office Building

Department:

IRB

Shift:
First Shift (United States of America)

Standard Weekly Hours:

40

Summary:

The Reliance Specialist is a key member of the HRPP team who has primary responsibility for the oversight and management of the reliance process and relationships between Cook Children's and external IRBs (institutional, central, and commercial). The Reliance Specialist is the first point of contact for physician investigators and their research teams when needing to initiate and execute a reliance relationship with an external IRB. The role also provides auditing support and post approval monitoring with respect to external IRB approved research protocols in order to ensure compliance with the human subject protection regulations, reliance agreements, and all applicable policies and procedures. The Reliance Specialist regularly interacts with reliance professionals at other institutions, local physician investigators and their research teams, interfacing departments, and internal leadership.

• Bachelor's Degree required in appropriate field (nursing, social or health science, or health-related management field)
• Minimum of 7-10 years of research-related, human subject protection, IRB, or research compliance experience required
• Knowledge of Federal regulations related to human subject protections as well as regulations specific to single IRB under the Revised Final Common Rule and NIH Mandate, e.g., DHHS, FDA, as well as Good Clinical Practice guidelines (as related to research), HIPAA, etc
• National Certification of IRB Professionals (CIP) required or is eligible to test for certification exam
• Ability to obtain certification in Healthcare Research Compliance (CHRC) or is eligible to test within 2 years of hire