Senior IRB Analyst
Senior IRB Analyst
Posted on :
06-04-2025
Employer Active
1 Vacancy
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Job Description
POSITION RESPONSIBILITIES
- Independently understands and applies the Federal Regulations for human research to all project applications (prereview rereview clarifying issues post meeting noncommittee review) to ensure adherence to regulatory and ethical standards.
- Independently conducts regulatory and administrative reviews of Exempt Expedited and Full Board submissions
- Evaluate investigator responses/requests
- Provides engagement determinations.
- Serves as an IRB member.
- Independently oversees Board meeting including but not limited to: making assignments to staff and Board members obtaining & maintaining quorum for the meeting and providing regulatory guidance at the meeting and writing minutes.
- Serve as the administrator for one of the following ancillary committees: Global Research Stem Cell Research or Fetal Tissue research. Ancillary committees function as an added level of review according to regulatory and/or institutional requirements and are conducted on an as needed basis. This will involve acting as a liaison between the IRB the research community the Office of General Counsel or other entities as required; ensuring all additional requirements are fulfilled before releasing approval. Supporting and educating and training board members in the review and approval of research subject to ancillary committee reviews. The administrator will also be involved in the oversight of the Committee functions including writing and maintaining minutes and relevant policies.
- Participate in IRB Analyst candidate interviews and provide onboarding training for new Analysts.
- Serves as ongoing mentor and educator for IRB Analysts assisting managers and directors with daytoday oversight of the department.
- Works closely with managers and directors within OHRA to set and implement priorities and to update policies and procedures.
- Assists OHRA leadership with internal QI monitoring and compliance.
- Participates in regional and national conferences and educational events.
- Provides regulatory and ethical consults for investigators and research personnel on human subjects research related issues.
- Gives presentations to IRB staff Board members and the research community.
- Other duties as assigned.
QUALIFICATIONS
- Bachelors Degree and 3 or more years of direct IRB experience required. Equivalent combination of experience and education will be considered
- Knowledge of applicable federal and state regulations (including 45 CFR 46 21 CFRrequired.
- CIP required within one year; CCRP certification a plus
- Must be able to work independently with minimal supervision.
- Excellent written and oral communications skills.
- Excellent customer service skills.
- Excellent ability to think creatively and demonstrate superb analytical reasoning ability.
- Strong familiarity with Microsoft Office (Word Windows Excel).
- Ability to adapt to custom webbased software.
- Ability to develop and lead educational programs and to train groups and individuals.
- Ability to exercise sound judgment integrity and initiative in implementing effective solutions.
Additional Information
In compliance with NYCs Pay Transparency Act the annual base salary range for this position is listed below. Albert Einstein College of Medicine considers factors such as (but not limited to) scope and responsibilities of the position candidates work experience education/training key skills internal peer equity as well as market and organizational considerations when extending an offer.
Minimum Salary Range
USD $75000.00/Yr.
Maximum Salary Range
USD $80000.00/Yr.
Required Experience:
Senior IC
Employment Type
Full-Time
Key Skills
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