Human Research Protections Specialist, Research & Sponsored Programs
Wake Forest University

Job Info

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** Cover letter required for all positions and optional for facilities, campus services, and hospitality positions unless otherwise specified.Job Description SummaryProvides guidance and problem resolution to researchers in the application of Federal/State laws, regulations, and guidelines, as well as University policies regarding human subjects research. Coordinates the administrative activities of the Institutional Review Board (IRB). Independently reviews and tracks new human subjects research, amendments, and continuing review applications, and documents all application activity. Plans and implements educational activities for IRB members and investigators.Job Description

Essential Functions:

• Advises and assists researchers with new human subject research applications and revisions.
• Conducts administrative review of all applications, amendments, and continuing reviews and assigns Board reviewers.
• Monitors progress of applications. Electronically generates approval letters and other IRB correspondence using eIRB.
• Independently answers queries and provides information regarding regulatory issues and application status to investigators and other study personnel.
• Ensures all study personnel have completed appropriate mandatory training, establishes new eIRB accounts, and troubleshoots account problems.
• Participates in IRB meetings.
• Provides guidance and problem resolution to researchers in the application of 45 CFR 46 and other Federal/State laws, regulations, and guidelines; IRB and University policies; and best practices regarding human subjects research.
• With the Associate Director, plans, implements, and participates in educational sessions for IRB members regarding regulations, policies, and procedures.
• Plans and implements education for investigators on human research protections requirements and best practices as well as updates to eIRB software.
• Maintains current and accurate records.
• Responsible for operation of the Human Research Protections Program in the Associate Director's absence.

Required Education, Knowledge, Skills, Abilities:

• BA/BS degree plus two years of experience in the administration of human subjects research activities.
• Demonstrated knowledge of laws, regulations, and policies relating to the protection of human research participants.
• Ability to work effectively with researchers and IRB members to provide program continuity on a daily basis.
• Presentation and training/education development skills.
• Ability to handle multiple projects.
• Excellent written and verbal communication skills; strong interpersonal skills.
• Expertise in Microsoft Office Suite (Word, Excel, PowerPoint, and Internet Explorer).
• Ability to work as a member of a team and/or independently.

Preferred Education, Knowledge, Skills, Abilities:

• Master's degree.
• Experience in a university environment.
• Certified IRB Professional (CIP) status, or the willingness to sit for the certification when eligible.
• Experience with electronic IRB system.

Accountabilities:

• May provide some work direction and problem solving for other staff and student assistants.

Physical Requirements: N/A

Environmental Conditions: N/A

Additional Job DescriptionTime Type RequirementFull timeNote to Applicant:This position profile identifies the key responsibilities and expectations for performance. It cannot encompass all specific job tasks that an employee may be required to perform. Employees are required to follow any other job-related instructions and perform job-related duties as may be reasonably assigned by his/her supervisor.In order to provide a safe and productive learning and living community, Wake Forest University conducts background investigations and drug screens for all final staff candidates being considered for employment.Wake Forest seeks to recruit and retain a diverse workforce while promoting an inclusive work environment committed to excellence in the spirit of Pro Humanitate. In adherence with applicable laws and as provided by University policies, the University prohibits discrimination in its employment practices on the basis of race, color, religion, national origin, sex, age, sexual orientation, gender identity and expression, genetic information, disability and veteran status and encourages qualified candidates across all group demographics to apply.

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