Emory University Research Protocol Analyst in atlanta, Georgia
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. Proficiently, and within target turnaround goals, screens and processes new research proposals, amendments, and 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. Attends continuing education offerings sponsored by or recommended by IRB leadership. If attending conference, disseminates new information to rest of IRB staff upon return. Assumes responsibility for continuous learning. Demonstrates willingness to learn new skills. Facilitates staff meetings on a rotating basis and disseminates staff meeting minutes. Provides weekly aging report to pod leader and/or Team Lead, with information on progress on outstanding items. May be assigned listserve monitoring, as described in listserve SOP. Alerts senior staff to problems with current SOPs or P&Ps, as applicable. Contributes to training of new staff members as assigned. May be asked to process Single Study IRB authorization agreements including obtaining legal review, as needed. 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. Recognizes and accepts additional responsibilities to support team and department by covering absences, assisting with increased workloads, sharing expertise and specific knowledge with team/coworkers, preparing for scheduled absences and delegating appropriately, following departmental and institutional policies on absences and leaving early. May be responsible for specialized handling of certain types of studies (e.g. Sponsor-Investigator studies); this may require collaboration with other compliance offices and fellow assigned IRB staff, and adherence to specialized SOPs and checklists. Depending on assignment, may also be responsible for the following: Meeting Facilitator Team: 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 the report after the audit. Manages SOP portfolio for the IRB office. Performs QA/QI internal activities. Theta Team: Under guidance from Senior team member, develops and executes processing and tracking of studies reviewed by external IRBs. Performs related responsibilities as required.
MINIMUM QUALIFICATIONS: Bachelor's degree and one year 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 preferred.
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Job Number 17836
Job Type Regular Full-Time
Division Research Administration
Department Institutional Review Board
This position may involve the following Health and Safety issues: Not Applicable
Job Category Research & Research Administration
Emory University is an equal opportunity/equal access/affirmative action employer fully committed to achieving a diverse workforce and complies with all applicable Federal and Georgia State laws, regulations, and executive orders regarding nondiscrimination and affirmative action in its programs and activities. Emory University does not discriminate on the basis of race, color, religion, ethnic or national origin, gender, genetic information, age, disability, sexual orientation, gender identity, gender expression, and veteran's status. Inquiries about this statement should be directed to the Office of Equity and Inclusion, 201 Dowman Drive, Administration Bldg, Atlanta, GA 30322