Summary: The IRB Compliance & Quality Assurance Specialist isresponsible for assisting with achieving and maintaining accreditation throughthe Association for the Accreditation of Human Research Protection Programs(AAHRPP) and developing continuous quality improvement initiatives that areconsistent with the accreditation standards. This position is also responsiblefor conduct of the post-approval research compliance program.
Bachelor's degree required in nursing, science, or healthrelated management field.
Minimum of 5 years of research-related, IRB, or researchcompliance experience required.
Knowledge of Federal regulations related to human subjectprotections, e.g., DHHS, FDA, as well as Good Clinical Practice guidelines (asrelated to research), HIPAA, etc.
Must have strong organizational, critical thinking, problemsolving, and writing skills.
Excellent attention to detail and must be able to completemultiple tasks independently as well as with direction.
Must have excellent project management skills.
Must possess strong verbal, written and interpersonalcommunication skills.
Able to communicate comfortably with physicianinvestigators, research personnel, and officials from otherdepartments.
Basic computer skills including Microsoft Word, MicrosoftOffice: Excel, Access, PowerPoint, and ability to work in various, otherinternet-based software applications.
Certified in Healthcare Research Compliance or is eligibleto test for certification exam within one year of hire.
Internal Number: 41626
About Cook Children's Health Care System
Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric health care organization comprised of eight entities – a Medical Center, Physician Network, Home Health company, Northeast Hospital, Pediatric Surgery Center, Health Plan, Health Services Inc., and Health Foundation.Cook Children's Medical Center Based in Fort Worth, Texas, the integrated system has more than 60 primary and specialty care offices throughout North Texas. Its service region includes Denton, Hood, Johnson, Parker, Tarrant and Wise counties, with an additional referral area encompassing nearly half the state.Cook Children's traces its roots back to 1918, but throughout its continual change and robust growth, it still embraces an inspiring promise – to improve the health of every child in its region through the prevention and treatment of illness, disease and injury. To live up to this promise, Cook Children's combines the art of caring with the use of leading technology and extraordinary collaboration to provide exceptional care for every child, every day.History – Cook Children's has a rich history of nearly a century of caring for children.Our Promise – Knowing that every child's ...life is sacred, it is the promise of Cook Children's to improve the health of every child in our region through the prevention and treatment of illness, disease and injury.Companies – Based in Fort Worth, Texas, Cook Children's is a not-for-profit organization that is comprised of eight nationally recognized companies.Community Health Outreach – Cook Children's Community Health Outreach works together with over 150 partner organizations to improve the safety and health of at-risk children through education, disease and injury prevention and support.Clinical Research – Cook Children's is home to a skilled team of research-minded physicians, nurses and health care professionals and administrators who drive our commitment to excellent clinical care and the search for medical advances.Public Relations – Cook Children's Public Relations works with national and local media outlets, produces Cook Children's publications, coordinates special events and helps develop key relationships within the community.Contractor & Vendor Information – Cook Children's contractors and vendors must ensure their employees are knowledgeable about working with our organization.Sponsorship guidelines – Cook Children's sponsors a select number of events that are strongly aligned with its promise to improve the health of every child in the region through the prevention and treatment of illness, disease and injury.