PRIM&R accepts advertisements from all institutions seeking to hire for positions in animal and human research ethics and related fields, such as research administration and ethics education; listing does not imply endorsement of the lister or of the qualifications stated for a position.
This position will interact with faculty investigators and members of the IRB and IRB staff.
Independently conduct the detailed administrative audit and processing of new Full Review studies and amendments (including the informed consent documents).
Independently audit and review Expedited submissions to ensure all regulatory elements are found in the submission materials as needed.
Attend monthly IRB meetings, write the minutes (ensuring that regulatory requirements are satisfied and documented), and communicate the outcome to the researchers.
Provide education to the IRB staff on proper IRB procedures, and regulations.
Respond to researcher's questions regarding policy and procedures.
Coordinate appropriate reviews and approvals from other institutional departments/committees including Office for Clinical Trials, Radiation Safety Committee, Conflict of Interest Committee, Finance, and the Clinical Research Center Protocol Review Committee.
Participate in the development and presentation of the IRB Continuing Education Program for faculty, research staff, IRB members.
Provide support to the research community on the web-based systems related to Expedited/ Full Review applications and amendments. Triage questions appropriately.
Responsible to monitor outstanding protocol transactions to facilitate timely approval for new full review protocols.
Immediately inform the Director/Associate Directors of significant staff, procedural or protocol non-compliance issues.
Recommend changes to operating procedures to work more efficiently and effectively.
Oversee the monthly distribution or IRB materials, help prepare the monthly full review agenda, and assist in assigning the primary and secondary reviewers.
Assist in the quality assurance of the department, identify deficiencies, and recommend solution and procedural changes to improve quality and efficiency.
Draft changes to operating procedures to work more efficiently and effectively for review by the IRB Director/Associate Directors and Joint Executive Committee.
Work closely with IRB staff, Director, Associate Directors, Chair, Principal Investigators, and other research staff to ensure the smooth processing of all research transactions.
The Albert Einstein College of Medicine is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Einstein seeks candidates whose skills, and personal and professional experience, have prepared them to contribute to our commitment to diversity and excellence, and the communities we serve.
Bachelor's degree required.
Graduate degree in a relevant field a plus.
3+ years IRB administrative experience.
CIP certification required.
Strong knowledge of applicable federal and state regulations (including 45 CFR 46, 21 CFR 50, 56, 312, 812)
Skills and Competencies:
Demonstrated administrative skills.
Must be able to work independently with minimal supervision.
Excellent written and oral communications skills.
Excellent customer service skills.
Strong familiarity with Microsoft Office (Word, Windows, Excel).
Ability to adapt to custom web-based software.
Ability to develop and lead educational programs, and to train groups and individuals.
Ability to exercise sound judgment and initiative in collection of information from a wide variety of sources