Institutional Review Board Manager - FT - Days - MHS

Memorial Healthcare

9d•Onsite

About The Position

The Institutional Review Board (IRB) Manager provides operational leadership, regulatory oversight, and staff supervision for the Institutional Review Board (IRB) office. This role ensures that human subjects research conducted at Memorial Healthcare System complies with all applicable federal regulations, state laws, institutional policies, and generally accepted ethical and research standards. The IRB Manager oversees daily office operations, supports Board members, guides investigators through the review process, and promotes a culture of ethical and compliant research.

Requirements

Masters (Required)
Certified IRB Professional (CIP) - Collaborative Institutional Training Initiative (CITI)
Five (5) years of experience working in an IRB office or as a reviewer of human subject research for regulatory compliance.
Master's degreed in a research or science related field.
Certified IRB Professional (CIP) required at time of hire.

Nice To Haves

Critical thinking skills
Effective communication
Decisive judgment
Ability to build and foster positive relationships
Ability to lead others
Ability to take appropriate action when required

Responsibilities

Serves as a subject matter expert and maintains up-to-date knowledge on federal, state, and local regulations related to protections of human subjects in research.
Ensures that IRB policies and procedures are in alignment with current regulations.
Develops training materials for IRB staff, Board members, and investigators.
Serves as the primary resource for investigators, research staff, and institutional leadership on IRB processes and regulatory requirements.
May lead IRB office staff, providing coaching, performance feedback, and professional development.
Fosters a collaborative, service-oriented environment that supports high-quality, and ethical compliance research.
Maintains and optimizes the electronic IRB system, workflows and templates.
Manages day-to-day operations of the IRB office and ensures timely review of new studies, amendments, continuing reviews, reportable events, and reliance requests.
Conducts reviews of complex scientific research protocols to ensure compliance with applicable regulations.
Determines review type, identifies regulatory and ethical issues, and facilitates revisions to submissions.
Makes final outcome determinations for submissions and communicates them to the Board members, study staff, and leadership.
Prepares the agenda and materials for the IRB meetings and distributes to IRB members.
Moderates the IRB meetings to ensure all required submission determinations are made by the Board.
Summarizes any controverted issues, their resolution, and the Board's action in meeting minutes in accordance with regulatory requirements.
Generates IRB correspondence related to action items and outcomes on each submission.