Senior Director IRB

Cleveland Clinic

11d•Hybrid

About The Position

At Cleveland Clinic Health System, we believe in a better future for healthcare. And each of us is responsible for honoring our commitment to excellence, pushing the boundaries and transforming the patient experience, every day. We all have the power to help, heal and change lives — beginning with our own. That’s the power of the Cleveland Clinic Health System team, and The Power of Every One. Job Details Join Cleveland Clinic’s Main Campus where research and surgery are advanced, technology is leading-edge, patient care is world class and caregivers are family. Here, you will work alongside a passionate and dedicated team, receive endless support and appreciation, and build a rewarding career with one of the most respected healthcare organizations in the world. As Senior Director, IRB, you will lead the Cleveland Clinic Human Subjects Protection Program and oversee all Institutional Review Board (IRB) operations, including policies, functions, technology and infrastructure across the enterprise. This role is responsible for the development, review and approval of IRB policies and procedures to ensure the protection of human research subjects and compliance with governmental regulations, ethical principles and accreditation standards. By providing expert leadership, education and guidance to IRB members and staff, you will advance continuous improvement in IRB operations, support timely and compliant review of research protocols, strengthen external partnerships and safeguard the rights and welfare of human research participants. This position plays a vital role in advancing Cleveland Clinic’s mission of caring for life, researching for health and educating those who serve by ensuring ethical integrity and regulatory excellence in research that drives innovative, life-changing medical advancements within a world-renowned academic medical center. This position follows a hybrid work schedule of 8:00 a.m. -- 5:00 p.m., with 2–3 days of remote work per week.

Requirements

Master's in Public Health, Business, Science or related fields, Law or Ph.D
10 years of experience in Medical Research
Healthcare background
Knowledge of IRB protocols and regulatory requirements
Strong interpersonal communication skills
Critical thinking skills, decisive judgment and ability work autonomously

Nice To Haves

Certified IRB Professional (CIP)
Extensive knowledge of research ethics, regulatory compliance and human subject protection
Experience managing IRB operations, overseeing staff and ensuring adherence to federal, state and institutional policies
Collaborative mindset to work with researchers and stakeholders effectively

Responsibilities

Lead the Cleveland Clinic Human Subjects Protection Program and IRB operations and functions, technology and infrastructure for all human research throughout the Enterprise, including the development.
Review and approve of IRB policies and procedures related to the management and protection of human research subjects.
Ensure compliance with governmental human subject regulations, ethical principles and accreditation.
Ensure efficient and effective processes for submission, acceptance and timely review of research protocols in compliance with regulatory and ethical principles by developing appropriate programs, systems and infrastructure.
Establish processes for the review of existing policies and procedures to ensure continuous improvement.
Provide determinations on regulatory questions, concerns, clarifications or issues of interpretation regarding IRB requirements and human research protections.
Provide expertise, advice, guidance, education and training to IRB members and IRB support staff regarding criteria for review and approval.
Serve on Clinic committees and various enterprise-wide groups requiring assistance from the IRB.
Work with various National and State organizations and universities to develop cooperative IRB initiatives and research arrangements and various other central IRBs and reliant IRB agreements.
Review, edit and approve IRB correspondence to inform Investigators of IRB actions to approve, modify, disapprove, suspend, or terminate research involving human subjects.
Other duties as assigned.