IRB Analyst II

I. JOB OVERVIEW

Job Description Summary:

The 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 II reports to the Assistant Director and manages the review of research study applications at all levels and stages of review and approval to ensure timely and accurate approval consistent with applicable regulations and institutional policy. This position is solution-oriented and provides outstanding, consistent customer service. This position will mentor IRB Analyst I.

• Independently conducts specialized risk, compliance, and protocol analysis of research applications in order to determine the nature and level of risk. Manages the research review process throughout the life cycle of a research proposal, which includes:
  • Management of the convened board meeting process, including serving as the primary consultant to the Board and to the investigators, making solution-oriented recommendations for changes to protocol and other documents to revise, minimize, or mitigate risk associated with the protocol and its use of human subjects and the analysis and documentation of Board discussions and preparation of stipulations.
  • Continued monitoring and management of research applications after the approval process by counseling investigators in regard to changes in study parameters, assisting in the development and implementation of solutions to resolve issues that affect research subject’s rights and welfare, and to ensure compliance with federal guidelines and University policies and procedures.
  • Conducts thorough and complete regulatory review of IRB applications to assure completeness, consistency, and accuracy.
  • Ensures accurate and timely processing, tracking, and filing of submissions and documentation of IRB actions.
  • Triages protocol submissions to determine the appropriateness of IRB review.
  • Determines correct level of regulatory IRB review required based on HHS and FDA regulations.
  • Provides IRB members with synopsis and regulatory guidance for all applications, from initial review through study closure.
  • Attends IRB meeting to serve as the regulatory subject matter expert, advising IRB Members and other OHR team members in management of IRB meetings and adherence to regulatory requirements.
• Self-motivated to independently manage time effectively and prioritize daily tasks, assisting coworkers as needed.
• Manages the Reliance process. This includes the review of Reliance Agreements and communication with internal and external entities to facilitate and execute these agreements. Ensure compliance with applicable regulations and institutional policy both when GW is the Reviewing IRB for multi-site research and when GW will Rely on external IRBs. Liaise with external IRBs, as necessary.
• Provides guidance to research investigators on the IRB application and approval process and requirements; and serves as a liaison to investigators, research coordinators, and other individuals across a variety of academic and medical center departments to analyze, interpret and resolve issues that impact the rights and welfare of human research subjects.
• Serves as a team lead for IRB Analyst I assisting in their professional development by providing guidance on OHR processes and workflows, institutional policy and federal and state regulatory requirements.
• Assists investigators, other members of the research team, and other regulatory partners by providing education and training regarding OHR and IRB requirements.
• Provides outstanding, consistent customer service which includes written and verbal communication with stakeholders and colleagues.
• Consistently evaluates process and workflow to ensure efficiency and compliance in the facilitation of research across the research enterprise and communicates effectively with OHR leadership any gaps or areas for improvement.
• Works with the electronic submission team to resolve problems, suggest improvements and test programming upgrades.
• Assists leadership in human research protection (re)accreditation processes.
• Seeks opportunities to identify self-development needs and takes appropriate action.
• Ensures own career discussions occur with appropriate management.
• Collaborates with OHR leadership on special projects, as needed, in support of the GW Human Research Protection Program.

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:

These qualifications are preferred:

• Certified IRB Professional
• 2+ years direct experience supporting IRB and Human Research Protections Program operations
• 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 communication skills and the ability to facilitate complex conversations about research integrity and ethics
• Effective problem solving, critical thinking, 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
• Customer-service oriented approach to supporting research compliance

Hiring Range

$57,553.66 - $79,165.63

GW Staff Approach to Pay

Healthcare Benefits

GW offers a comprehensive benefit package that includes medical, dental, vision, life & disability insurance, time off & leave, retirement savings, tuition, well-being and various voluntary benefits. For program details and eligibility, please visit

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

Hours Per Week:

40

Work Schedule:

M – F: 8:00 am – 5:00 pm

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:

S013379

Job Open Date:

10/15/2024

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.