IRB Analyst ll, Research Reliance - Washington, United States - George Washington University

Description

I. JOB OVERVIEW

Job Description Summary:

Office of Human Research (OHR) supports The George Washington University research community in the conduct of innovative and ethical research by providing guidance, education, and oversight for the protection of human subjects.

The IRB Analyst ll, Research Reliance is responsible for the oversight, implementation, and management of the reliance process and relationships between the GW IRB and external IRBs (institutional and commercial), including the administrative and analytical review and processing of reliance agreements, independent investigator agreements, and memorandums of understanding. This position will develop policies, guidelines, and procedures related to the reliance process; serve as key liaison/point of contact during the reliance process between the GW IRB, GW researchers, and external institutions/IRBs, including relationships utilizing the sIRB model. This position will exercise independence and discretion in managing relationships with external organizations and processing reliance agreement documentation. This position will develop educational materials and serve as a resource in outreach sessions and in meetings with research teams about the reliance agreement process.

GOALS:

• To develop and solidify GW OHR reliance policies and procedures.
• To present to GW researchers and external institutions/researchers a clear, consistent, and transparent reliance process.
• To serve as an educational resource and expert to the GW research community regarding the reliance agreement process.

DUTIES AND RESPONSIBILITIES:

• Determines eligibility to rely on external reviewing IRBs based on institutional policies and standard operating procedures.
• Reviews and manages requests from GW researchers to rely on an external IRB; ensures GW researchers have completed and submitted the required reliance forms, that GW researchers have completed their required training, and that GW required information, if applicable, is incorporated into the local consent forms approved by the reviewing IRB and performs routine follow-up as needed to minimize delays. Submits reliance agreements to the GW institutional official for final review and signature, and/or processes the agreement through SMART IRB or IREx. Conducts reviews of applications for relying sites overseen by the GW sIRB, in compliance with all applicable federal, state, and local regulations as well as institutional policies, procedures, and guidelines.
• Reviews and manages requests from external institutions to rely on the GW IRB; reviews reliance forms to assure that the required information has been completed and submitted and verifies that GW training requirements have been met by the relying sites. Ensures that site-specific consent language is included in the GW IRB approved consent forms as applicable (such as payment for injury, HIPAA). Meets with GW researchers, OHR Staff, and external organizations to develop a clear reliance agreement plan and foster and promote collaboration with external organizations. Solicits local context information and requirements from external participating sites; when GW is reviewing sIRB, identifies requirement(s) for review by the ancillary committees, or communication or coordination with other departments, groups, or individuals within the institution that share responsibility for human subject protections.
• Reviews and manages requests from independent investigators to rely on the GW IRB; reviews reliance forms to assure that the required information has been completed and submitted and verifies that GW training requirements have been met by the independent investigators when appropriate.
• Maintains GW OHR reliance documentation, files, and logs; reviews and acknowledges updates to reliance agreements, including changes in personnel (internal and external). For reliance agreements where GW is IRB of Record, verifies finalized agreements are in place and are kept up to date.
• Assists with the preparation of budget estimates when the GW IRB acts as the reviewing sIRB.
• Serves as the primary liaison for GW investigators relying on external IRBs and for investigators at sites relying on the GW IRB for sIRB oversight in multi-site research.
• Tracks external IRB initial and post-approval reviews; updates records for reporting purposes; requests information from reviewing IRBs, as needed.
• Establishes and manages a process to oversee research projects reviewed by a commercial IRB. Creates a process for running metrics and assessments of the reliance portfolio.
• Interprets and applies federal and state regulations, and institutional policies, relevant to human research and reliance agreements.
• Communicates areas of improvement and growth to GW OHR staff and GW researchers with the goal of improving the reliance process. Approves administrative and procedural modifications.
• Advises and provides guidance to GW OHR staff, GW researchers, and external institutions/independent investigators to facilitate the use of reliance agreements.
• Develops and implements training/educational materials and guidance for the GW research community regarding the use of reliance agreements.
• Works with the GW OCG to address any legal and institutional requirements related to reliance agreements that require unique or additional considerations.
• Performs other related duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.

Minimum Qualifications:

Qualified candidates will hold a Bachelor's degree in an appropriate area of specialization plus 2 years of relevant professional experience, or, a Master's degree or higher in a relevant area of study. Degree must be conferred by the start date of the position. Degree requirements may be substituted with an equivalent combination of education, training and experience.

Additional Required Licenses/Certifications/Posting Specific Minimum Qualifications:

Preferred Qualifications:

• Experience developing IRB policies and procedures
• Certified IRB Professional CIP
  
  
• Master's degree or an equivalent combination of relevant education and experience
• 2+ years experience in IRB operations and/or sIRB/Reliance processes
• Effective communication skills, has the ability to facilitate complex conversations about integrity and ethics
• Extensive working knowledge of federal, state, and local regulations to ensure the GW IRB and Human Subjects Research Program are in compliance with applicable mandates
• Effective problem solving and decision-making skills and the ability to make decisions independently
• Ability to take initiative and simultaneously manage multiple projects with minimal supervision
• Highly organized and able to prioritize and handle multiple tasks simultaneously

Typical Hiring Range

Commensurate with Experience.

II. JOB DETAILS

Campus Location:

Foggy Bottom, Washington, D.C.

College/School/Department:

Office Vice President of Research (OVPR)

Family

Research Administration

Sub-Family

Research Compliance

Stream

Individual Contributor

Level

Level 2

Full-Time/Part-Time:

Full time -> FTE 1.00

Hours Per Week:

40

Work Schedule:

Weekdays (Monday-Friday)

Will this job require the employee to work on site?

Yes

Employee Onsite Status

Hybrid

Telework:

Yes

Required Background Check:

Criminal History Screening, Education/Degree/Certifications Verification, Social Security Number Trace, and Sex Offender Registry Search

Special Instructions to Applicants:

Employer will not sponsor for employment Visa status

Internal Applicants Only?

No

Posting Number:

S012655

Job Open Date:

11/14/2023

Job Close Date:

If temporary, grant funded or limited term appointment, position funded until:

Background Screening

Successful Completion of a Background Screening will be required as a condition of hire.

EEO Statement:

The university is an Equal Employment Opportunity/Affirmative Action employer that does not unlawfully discriminate in any of its programs or activities on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity or expression, or on any other basis prohibited by applicable law.