Location:
Rosedale Office BuildingDepartment:
IRBShift:
First Shift (United States of America)Standard Weekly Hours:
40Summary:
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 Childrens 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:
Bachelors 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 Childrens Health Care System
Cook Childrens Health Care System offers a unique approach to caring for children because we are one of the countrys leading integrated pediatric health care delivery organizations. Patients benefit from the integrated system because it allows Cook Childrens 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 Childrens is an equal opportunity employer. As such Cook Childrens 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.
Required Experience:
IC
Whether it's parenting issues or treating the most complex pediatric medical conditions, Cook Children's is here, helping families navigate childhood every step of the way.