Columbia University Senior IRB Specialist in New York, New York

Position Information

Job Title

Senior IRB Specialist

Job Code Title

Job Requisition Number

090009

Department

0912- RES Institutional Review Board

Location

Medical Center

Job Type

Officer Full-Time Regular

Bargaining Unit

If temporary, indicate duration

Hours Per Week

35

Job Family

General Administration

Salary Grade

Officer 105

Salary Range

Commensurate with experience

Advertised Summary Job Description

The Senior IRB Specialist of the Institutional Review Board (IRB)/ Senior Manager, reports to the Assistant Director for IRB Management of the Columbia University Human Research Protection Office (HRPO). This staff member will join other professionals who are responsible for management of the IRB operation.

Specific responsibilities will include management and supervision of staff assigned to provide administrative and regulatory support to one IRB in a manner that will ensure the respective IRB is in compliance with all federal and regulatory requirements and accreditation standards. Additionally, the team must be managed for efficient and high quality performance.

Other responsibilities include:

  • Ensuring that minutes are in compliance with federal regulatory standards.

  • Conducting pre-review of submissions to CUMC IRBs.

  • Providing regular feedback to the Assistant Director regarding team performance, need for personnel, policy, or procedural changes, and IRB issues.

  • Working closely with the IRB Chair(s) to provide administrative support in the review and processing of submissions.

  • Ensuring that all correspondence related to the respective IRB is accurate, appropriately formatted, and comprehensive prior to release.

  • Serving on committees constituted to improve the functioning of the IRB office.

  • Being aware of institutional entities, policies, and relationships that affect IRB functioning.

  • Advising investigators to facilitate efficient review of submissions.

  • Serving as voting member of IRB.

  • Other work as assigned.

This staff member will also work with other IRB officers of administration and staff to ensure uniformity of review and compliance with IRB standard operating procedures and applicable federal and state regulations.

The Senior IRB Specialist will maintain up to date knowledge of state and federal regulations as well as policies, guidelines and ethical codes related to the protection of human subjects in research.

Minimum Qualifications for Grade

Applicant MUST meet these minimum qualifications to be considered an applicant

A bachelor's degree or equivalent, plus four years of related experience, of which at least two years should be of direct IRB experience.

Additional Position-Specific Minimum Qualifications

Applicant MUST meet these minimum qualifications to be considered an applicant

The Senior IRB Specialist must have up to date knowledge of state and federal regulations and be familiar with policies, guidelines and ethical codes related to the protection of human subjects in research. Strong interpersonal and writing skills, and experience with computerized databases and word processing, are essential.

Special Instructions

Preferred Qualifications

Experience with biomedical, behavioral, and social sciences human research, knowledge of international ethical codes and regulations governing human subjects research, and certification as an IRB professional are preferred.

Experience with biomedical, behavioral, and social sciences human research, knowledge of international ethical codes and regulations governing human subjects, and certification as an IRB professional are preferred.

Essential Functions

Additional Essential Functions (Limit to 3950 characters.)

Special Indications

This position works with:

There are no special indications for this position

HIPAA Compliance training required

Yes

Participation in Medical Surveillance required

No

What type of posting? Is this a waiver request?

Standard Posting

Requisition Open Date

10-11-2017

Requisition Close Date

Open Until Filled

Quick Link

jobs.columbia.edu/applicants/Central?quickFind=165244

EEO Statement

Columbia University is an Equal Opportunity/Affirmative Action employer.

Local Hiring

Columbia University is committed to the hiring of qualified local residents.