Research Protocol Analyst I - Institutional Review Board - Emory Healthcare/Emory University

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Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the diversity and excellence of our academic community.

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. KEY RESPONSIBILITIES: + 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. NOTE: This role will be granted the opportunity to work from home regularly but must be able to commute to Emory University location as needed and at times, on short notice. Emory reserves the right to change this status with notice to employee.

Emory Supports a Diverse and Inclusive Culture

Emory University is dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, gender, genetic information, age, disability, sexual orientation, gender identity, gender expression, and veteran's status. Emory University does not discriminate in admissions, educational programs, or employment on the basis of any factor stated above or prohibited under applicable law. Students, faculty, and staff are assured of participation in University programs and in the use of facilities without such discrimination. Emory University complies with Executive Order 11246, as amended, Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity and affirmative action. Emory University is committed to achieving a diverse workforce through application of its affirmative action, equal opportunity and nondiscrimination policy in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Inquiries regarding this policy should be directed to the Emory University Department of Equity and Inclusion, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Emory University is committed to providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to request a reasonable accommodation, please contact the Department of Accessibility Services at 404-727-9877 (V) | 404-712-2049 (TDD). Please note that one week advance notice is preferred.

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Job Number

_133675_

Job Type

_Regular Full-Time_

Division

_Research Administration_

Department

_Institutional Review Board_

Job Category

_Research Administration_

Campus Location (For Posting) : Location

_US-GA-Atlanta_

_Location : Name_

_Emory Campus-Clifton Corridor_

Remote Work Classification

_Primarily Remote – Monthly_

Health and Safety Information

_Not Applicable_