HRRP Reliance Specialist

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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.

Qualifications:

• 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

About Us:

Cook Children's Health Care System

Cook Children's Health Care System offers a unique approach to caring for children because we are one of the country's leading integrated pediatric health care delivery organizations. Patients benefit from the integrated system because it allows Cook Children's to use all of its resources to treat a patient and allows for easy communication between the various companies by physicians with a focus on caring for children and adolescents.

Cook Children's is an equal opportunity employer. As such, Cook Children's offers equal employment opportunities without regard to race, color, religion, sex, age, national origin, physical or mental disability, pregnancy, protected veteran status, genetic information, or any other protected class in accordance with applicable federal laws. These opportunities include terms, conditions and privileges of employment, including but not limited to hiring, job placement, training, compensation, discipline, advancement and termination.