JOB DESCRIPTION: This is a human research regulatory compliance position that, depending on team assignment, may involve: pre-review and tracking of new research proposals; amendments and continuing reviews of existing research protocols; and adverse event reports. May also involve meeting facilitation and recording of meeting minutes, and/or education and outreach; and/or quality assurance monitoring.
Depending on assignment, may also be responsible for the following: Meeting Facilitators: With guidance from senior team member, proficiently facilitates and documents IRB Committee Meetings according to institutional and IRB policies and procedures and federal regulations; QA/Education Team: Leads and/assists with QA/QI external activities, preparing reports after audits in collaboration with study teams; Manages SOP portfolio for the IRB office; Performs QA/QI internal activities; Assists with outreach program and IRB website management.
Screens and processes new research proposals and amendments applications according to institutional and IRB policies and procedures and federal regulations. Screens and processes continuing review applications according to institutional and IRB policies and procedures and federal regulations. Offers guidance to study teams on the applicable regulations and policies, on how to prepare quality IRB submissions, including the preparation of protocol and informed consent documents, and how to navigate the eIRB system. Provides education to the Emory research community in the form of outreach presentations and/or webinars in topics such as reportable events, IRB submission and informed consent process. Attends continuing education offerings sponsored by or recommended by IRB leadership; disseminates new information to rest of IRB staff upon return.
Facilitates staff meetings on a rotating basis and disseminates staff meeting minutes. Provides weekly aging report to group leader and/or Team Lead, with information on progress on outstanding items. May be assigned listserve monitoring, as described in listserve SOP. As needed, collaborates with senior staff to improve current SOPs or P&Ps. Contributes to training of new staff members as assigned. Collaborates with colleagues as needed to ensure that all applicable institutional approvals and external IRB reliance agreements are in place before finalizing Emory IRB approval. Ensures the integrity and security of IRB data, whether in paper or electronic format. Adheres to institutional and departmental confidentiality and security policies and procedures. Performs related responsibilities as required.
MINIMUM QUALIFICATIONS: Bachelor's degree and 18 months of experience in health care, research or regulatory positions or an equivalent combination of education, training and experience. Experience utilizing basic analytic skills desirable (e.g., behavioral/social sciences, education, business, math, engineering or criminology) desirable. Previous IRB experience and CIP certification preferred. |
Emory is an EEO Employer-Disability/Veteran. Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. |
Human Resources