IRB Associate Analyst

Children's Healthcare of Atlanta

About The Position

Under general supervision, performs a variety of administrative and technical duties to coordinate and support the IRB processes within Children’s Research program to ensure protection of human subjects throughout the research process.

Requirements

Working knowledge of federal regulations related to the protection of human subjects in research
Working knowledge of information systems, including PC and Microsoft Office (Word, Excel, PowerPoint), Adobe Acrobat, electronic IRB systems, CTMS, EMR, Electronic Data Capture (EDC) systems and associated databases.
Bachelor's degree in a scientific or health-related field, or a Bachelor's degree in a non-scientific or health related field with relevant experience.
Collaborative Initiative Training (CITI) within 30 days of employment
Must demonstrate a high degree of clerical accuracy, with attentiveness to detail and the ability to organize data
Demonstrated ability to organize and prioritize work
Excellent customer service skills
Excellent verbal and written communication skills
Ability to maintain standards of confidentiality
Ability to meet deadlines
Ability to work independently with minimal supervision
Experience interpreting and applying federal regulations

Nice To Haves

Knowledge of medical terminology
Graduate degree
Pediatric experience

Responsibilities

Assists leadership with IRB meetings including meeting organization, ensuring quorum, screening studies, preparing, and sending packets and completion of minutes.
Independently providing technical advice, providing problem-solving assistance, and answering questions about research studies. Referring inquiries to others as needed.
Maintains accurate, complete, and confidential IRB records including but not limited to; policies and procedures, submission forms, document templates, federal documents, correspondence with external agencies, studies submitted for IRB; and training certifications.
Works with investigators and other key research personnel, as well as applicable administrative staff and IRB members, to ensure all have obtained the appropriate human subjects research training certification. Monitor expiration dates of studies. Send reminder notices to investigators prior to the expiration date. Identify any studies that have expired and ensure that the studies are administratively closed per federal regulations and institutional policy.
Completes correspondence following IRB reviews of submissions. Including: creating letters from the IRB meeting minutes, drafting approval notices and acceptance/acknowledgement letters and stamping the informed consent forms and recruitment materials as necessary, and drafting response letters to investigators based on the findings of expedited IRB reviews.
Serves as a resource to investigators and research staff regarding Children’s policies, federal regulations, and study status.
Supports the IRB submission intake process, including conducting preliminary review of all human subject’s research submissions for accuracy, completeness, and compliance with federal regulations and Children’s policies.
Reviews and processes IRB applications and other submissions to determine whether the investigator has completely addressed all areas needed by the IRB; will communicate with investigators and provide them with guidance on how to fulfill those requirements; provides feedback to the investigator on privacy, confidentiality, risks, benefits, etc.; Determines which projects are ready for IRB review, and communicates with IRB reviews to identify potential problems that need to be addressed.
Participates in quality and performance improvement activities within the department.
Provides administrative support to the IRB leadership as needed.
Supports leadership in advising the IRB Chair and members.
Assists leadership with AAHHRP requirements including renewal applications and re-accreditation.
Prepares and delivers education to IRB members as necessary and appropriate.