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Job Title

Senior Director IRB:

Location

Cleveland

Facility

Cleveland Clinic Main Campus:

Department

CRAO Central Administration-Research Innov and Educ:

Job Code

T97816

Shift

Days

Schedule

8:00am-5:00pm

Job Summary

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.

A caregiver who excels in this role will:

• 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.

Minimum qualifications for the ideal future caregiver include:

• 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

Preferred qualifications for the ideal future caregiver include:

• 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

Physical Requirements:

• Ability to perform work in a stationary position for extended periods.

• Ability to operate a computer and other office equipment.

• Ability to communicate and exchange accurate information.

Personal Protective Equipment:

• Follows Standard Precautions using personal protective equipment as required.

The policy of Cleveland Clinic Health System and its system hospitals (Cleveland Clinic Health System) is to provide equal opportunity to all of our caregivers and applicants for employment in our drug free environment. All offers of employment are followed by testing for controlled substances.

Cleveland Clinic Health System administers an influenza prevention program. You will be required to comply with this program, which will include obtaining an influenza vaccination on an annual basis or obtaining an approved exemption.

Decisions concerning employment, transfers and promotions are made upon the basis of the best qualified candidate without regard to color, race, religion, national origin, age, sex, sexual orientation, marital status, ancestry, status as a disabled or Vietnam era veteran or any other characteristic protected by law. Information provided on this application may be shared with any Cleveland Clinic Health System facility.

If applying for a Florida position, please see the following website for more information on the background screening requirements required by the Agency of Health Care Administration: https://info.flclearinghouse.com/

Please review the Equal Employment Opportunity poster.

Cleveland Clinic is pleased to be an equal employment opportunity employer.