IRB Reg. Affairs Administrator, Institutional Review Board at Carilion Clinic in Roanoke, Virginia

Job Description:

How You'll Help Transform Healthcare:

Provides expertise in and works independently to administer IRB regulatory review of expedited and exempt research protocols. Determines whether full committee review of research is required. Leads targeted reviews and audits of human subjects research to address IRB-related concerns about compliance with federal and state regulations and internal guidelines. Develops and leads education programs for principal investigators, clinical research professionals and other research staff about Good Clinical Practices governing human subjects research as well as IRB requirements for research. Manages IRB review of human subjects protocols in biomedical, and social and behavioral sciences. Leads assessment of quality assurance and quality improvement studies to determine if they qualify as human subjects research.

Job duties include but are not limited to:

• Determines if research proposal are classified as expedited, exempt, or non-human subjects research and oversee review of these studies. Determines whether full committee review of research is required. Determine when protocols require special attention due to their complexity and sensitivity. Provides review and feedback about the IRB application, data collection forms, and informed consent document. Processes and maintains records of these studies.
• Lead targeted reviews and audits of research compliance issues in consultation with the Director of Biomedical and Research Ethics, IRB Chair, and others involved in oversight of clinical research.
• Develops and implements appropriate procedures for the submission, review and approval, and amendment of research projects. Conducts reviews for continuing approval and other reportable events. Provide expertise and guidance to investigators and other research staff involved in the conduct of biomedical, and social and behavioral research studies. Meet with students from VTCSOM to provide education and answer questions about research topics.
• Determine whether the IRB is functioning in compliance with federal and state regulations and guidelines through the use of checklists and guidance documents issued by the Office of Human Research Protections, the Food and Drug Administration and other governmental and professional agencies.

What We Require:

Education: Bachelor's degree required preferably in the biomedical or social/behavioral sciences, ethics, or related discipline or equivalent 8 years of experience required. Master's Degree is preferred, Clinical experience is helpful.

Experience: Minimum of 8 years experience in health administrative, regulatory compliance, research, or related field. Preferred experience in working with an IRB and/or human subjects research oversight.

Licensure/certification: Possession of Certification as a Certified IRB Professional (CIP) or obtaining CIP within two years of employment. Certification as a Clinical Research Professional is an acceptable alternative.

About Carilion

This is Carilion Clinic ...

An organization where innovation happens, collaboration is expected and ideas are valued. A not-for-profit, mission-driven health system built on progress and partnerships. A courageous team that is always learning, never discouraged and forever curious.

Headquartered in Roanoke, Va., you will find a robust system of award winning hospitals, Level 1 and 3 trauma centers, Level 3 NICU, Institute of Orthopedics and Neurosciences, multi-specialty physician practices, and The Virginia Tech Carilion School of Medicine and Research Institute.

Carilion is where you can make your own path, make new discoveries and, most importantly, make a difference. Here, in a place where the air is clean, people are kind and life is good. Make your tomorrow with us.

Requisition Number: 150003
Employment Status: Full time
Location: CASB - Carilion Administrative Services Building
Shift: Day
Shift Details: Monday through Friday; 8:00 a.m. to 4:30 p.m.
For more information, contact the HR Service Center at 1-800-599-2537.

Equal Opportunity Employer

Minorities/Females/Protected Veterans/Individuals with Disabilities/Sexual Orientation/Gender Identity

Carilion Clinic is a drug-free workplace.

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