Posting Summary:

The Institutional Review Board (IRB) Office at the Teachers College (TC) functions to ensure that all human subject research conducted at the University is in compliance with applicable laws, regulations, and University policies.

In support of TC’s mission and vision, the IRB is seeking a Reliance Agreement Specialist who will serve as the primary point of contact for multisite research when Teachers College will either rely on the review of an external IRB, or serve as the single IRB for other sites.

Job Summary/Basic Function:

The External IRB Administrator serves as the primary point of contact for multisite research when Teachers College will either: 1) rely on the review of an external IRB, or 2) serve as the single IRB for other sites. Reviews, negotiates terms and facilitates the execution of IRB reliance agreements. Coordinates and oversees activities related to institutional responsibilities as outlined in the agreements and/or dictated by federal, state or local laws and policies.

JOB DESCRIPTION
– Serves as the primary point of contact and provides guidance to investigators who wish to establish the use of the Teachers College as a single IRB or rely on an external IRB for multi-center research.
– Develops policies, procedures, and tools to facilitate and streamline practices related to the reliance agreement review process, institutional responsibilities, and local review as applicable.
– Reviews, negotiates terms, and facilitates the execution of reliance agreements.
– Acts as the liaison between Teachers College, the local investigator/staff and any external IRB(s).
– Provides review of local considerations for studies as outlined in the terms of the reliance agreements (i.e., verifying training of the research team, reviewing consent forms for local context, reviewing financial disclosures for conflicts of interest, or ensuring local ancillary reviews are completed).
– Performs administrative review of and processing of documents from participating institutions; coordinates IRB review when serving as the single IRB.
– Oversees and participates in monitoring activities to ensure all regulatory and compliance requirements are met, protocol files are maintained, and to ensure all responsibilities of reliance agreements are fulfilled.
– Identifies and tracks key metrics relating to IRB review under reliance agreements (studies for which Teachers College relies on an external IRB, studies/sites for which Teachers College serves as the single IRB, turnaround times, etc.).
– Manages and updates all reports, tracking systems, and documents pertaining to reliance agreements, single IRB, and/or multisite negotiations.
– Maintains advanced knowledge of federal regulatory requirements and institutional policies and procedures.
– Develops and implements related training/educational materials for the research community and IRB staff.
– Reviews unanticipated problems or suspected noncompliance; reports to the IRB, applicable institutions and regulatory agencies as dictated in the agreements.
– Facilitates or supports local context reviews for international sites.
– Other job functions as assigned.

Minimum Qualifications:

● Bachelor’s degree in a related field required.
● 3 years IRB related experience as a Research Compliance Coordinator (IRB Analyst)
level;
● Detailed knowledge of federal, state, and local regulations and an in-depth understanding of ethical principles regarding the protection of human subjects in research. Working knowledge of local and federal regulations for human subjects research (OHRP, FDA regulations).
● Excellent customer service, project management, and process improvement skills.
● Ability to take initiative, prioritize tasks to meet deadlines, produce results and cope with the inherent pressures.
● Excellent organizational and analytical skills: ability to apply sound judgment and take initiative in collection of information from a wide variety of sources; ability to identify and resolve issues.
● Excellent oral and written communication skills; effectively communicates with all levels of the organization; good presentation and training skills.
● Ability to perform multiple tasks with a high level of accuracy and attention to detail.
● Proficient computer skills (Excel, Word, Outlook, Access, PowerPoint; Google Docs).

Preferred Qualifications:

● Demonstrates the knowledge and skills necessary to provide care appropriate to the ages served on the assigned unit/department, as indicated in the competency skills checklist.
● Certification or eligibility to sit for Certification Exam for Certified IRB Professional (PRIM&R).
● Experience at Teachers College.
● Master's degree.

Salary Range:

$60,800-$76,000

Work Modality:

Hybrid