Director IRB Ops

Beth Israel Lahey Health•Boston, MA

4d•$155,002 - $184,995•Onsite

About The Position

When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives. The Director, IRB Operations, reports to the Director, Human Research Protection Program (HRPP). This position is responsible for administrative oversight for all operations supporting the functions of the BIDMC Committee for Clinical Investigations-Institutional Review Board (CCI-IRB). The primary areas of responsibility are 1) management of CCI-IRB staff, including IRB Manager and Reliance Manager, 2) serving as the administrative interface between the Chair and other Vice-chairs and the CCI-IRB staff and the clinical research community, and 3) serving as the primary regulatory/ethical resource for CCI committee members, researchers, and research coordinators on humans subject protection, and 4) works with the Director of the Human Research Protection Program for the development, implementation and management of Institutional Review Board policies and procedures and the related administrative operations of CCI protocol office in order to comply with all federal and state regulations; 5) making determinations of research engagement / human subjects research; 6) work with BILH legal and Sponsors to revise consent language where changes are requested to the template language. Job Description: The following statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities and skills required of this position.

Requirements

Bachelor's degree required.
8-10 years related work experience required in Human Subjects Research, including 3-5 years of supervisory/management experience required.
Advanced skills with Microsoft applications which may include Outlook, Word, Excel, PowerPoint or Access and other web-based applications. May produce complex documents, perform analysis and maintain databases.

Nice To Haves

Master's degree preferred.
CIP certification

Responsibilities

In collaboration with the IRB Manager, manages all CCI-IRB staff, their work product, handles employee relations issues with Human Resources as needed, and all other administrative aspects of the office (essential)
Provides guidance and consultation to CCI board members and staff, and to investigators and research staff, regarding current issues and ethical concerns in human subject protection. This includes guidance on associated HHS, FDA, and institutional regulations, policies, procedures, and guidelines. (essential)
Consults with Committee Chair and administratively manages and coordinates Chair/Vice-chair reviewer schedules, establishes guidelines for Chair/Vice-chair reviewer consistency. Works with Committee Chair to establish review consistency across full board and continuing review board activities and perform IRB Vice Chair and committee member evaluations. Contributes significant administrative and regulatory comments to pre-review of continued protocols (essential)
Provides oversight for the workflow and submission of BILH protocols being submitted to the BIDMC IRB for review. Provides guidance for the institutional reviews at the home institution and ensure non-compliance is communicated with home institutional leadership. (essential)
Works with the Chair, Vice Chairs, Institutional Official, and HRPP Director to formulate short-term and long-term goals and objectives for the CCI and administrative staff, including planning the annual IRB retreat. (essential)
Prepares training materials: Revises forms and documents, web content and other materials as needed to ensure adherence to regulations and policies. (essential)
Maintains IRB committee membership in accordance with regulations, assuring breadth of experience, expertise, and diversity in accordance with the institutional Assurance and orients new IRB members. (essential)
Serves as a key member of the IRB Executive Committee and the Vice Chair Committee, and Conflict of Interest Committee. Serves as the key user representative on the IRB system changes. (essential)
Updates HRPP Director when reports/updates must be made to BIDMC research community, other institutional departments, and external regulatory agencies. (essential)
Has the authority to direct and support managers with functional area responsibilities. Has the direct responsibility to undertake the following employment actions: hiring, termination, corrective action and performance reviews.
Assists in planning, monitoring and/or managing budget in functional area of department.