Senior IRB Specialist at The Trustees of Columbia University in the City of New York Job Listing at DirectEmployers in New York, NY (Job ID 3951504-2024-07-13)

Description

• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Standard Work Schedule: 9am - 5pm
• Salary Range: $80,000-$95,000

Position Summary

The Review Board (IRB)/Manager, reports to the Assistant Director for IRB Management of the Columbia University Human Research Protection Office (HRPO).

The Senior IRB Specialist is responsible for the management of a substantial portfolio of research protocols submitted for IRB review, facilitating regulatory support to a CU IRB and ensuring the respective IRB is in compliance with all federal regulatory and local requirements and accreditation standards. This staff member will join other professionals who are responsible for management of the IRB operation.

Responsibilities

• Core responsibilities

  • Manage a large volume of research protocols and related submissions, from assignment through IRB approval, and ensure high level of quality and uniformity of review of these protocols
  • Ensure research protocols submitted for IRB review are in compliance with CU IRB standard operating procedures (SOPs) and institutional policies as well as applicable federal and state regulations
  • Lead the designated IRB team to meet HRPO's expectation for quality, productivity and goal accomplishment; encourage IRB specialist contribution and provide feedback.
  • Supervise and train direct report(s) to provide administrative and regulatory support to one IRB in accordance with HRPO's policies and procedures
  • Ensure direct report(s) assess research protocols for completeness, accuracy, and level of review according to applicable regulation and/or institutional policy in an efficient manner
  • Train direct report and/or ensure direct report is trained in accordance with the core educational program that is required for research personnel. Participates in the orientation and training of other HRPO personnel, including peers;
  • Assign tasks to team members supporting one IRB to ensure that the following is conducted:
  • A detailed independent analysis of protocols specific events submitted for IRB, document submission-specific findings and generate Principal Investigator (PI) notification regarding the outcome of the review;
  • Evaluate PI responses and identify regulatory items for IRB reviewers; advise as to whether or not the requirements for IRB approval have been met;
  • Evaluate performance of direct report(s) at least annually
  • Participate in the evaluation of the IRB Chairs and members
  • Guide IRB Chairs and IRB reviewers with the application of regulatory requirements and provide them with the necessary information to conduct their reviews
  • Train new IRB members on how to use the CU electronic review system (Rascal) and facilitate onboarding.
  • Ensure the accuracy of the records generated by the team, Chair and IRB reviewers
  • If responsible for supporting a CU IRB that process protocols to be reviewed by the convened IRB:
  • Ensure the organization of convened IRB meetings for review of research as per HRPO pre-determined schedule or more frequently when determined to be necessary.
    • Manage pre-meeting, meeting and post-meeting activities of the convened IRB in partnership CU IRB Chair and other ancillary review committee when applicable; Includes agenda management, meeting facilitation and all aspects of IRB minutes documentation;
    • Provide regul

      Compensation Information:
      $80000.0 / Yearly - $80000.0 / Yearly
      

      
      Starting At: 80000.0 Yearly
      Up To: 95000.0 Yearly