Research Coordinator II - IRB Specialist

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Job Title

Research Coordinator II - IRB Specialist

Location

Cleveland

Facility

Cleveland Clinic Main Campus

Department

HVTI Research and Registries-Main Campus Hospital

Job Code

T99498

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 a Research Coordinator II supporting Heart, Vascular & Thoracic Institute (HVTI) Institutional Review Board (IRB) activities for retrospective and minimal risk research studies, you will play an essential role in supporting research operations, ensuring regulatory compliance, and advancing innovative healthcare initiatives. In this role, you will serve as a resource for IRB WebKit training and education for HVTI research personnel, coordinate IRB submissions for new retrospective, minimal risk prospective, and registry studies, and prepare documentation for new studies, amendments, continuing renewals, and closures. You will review and maintain IRB study statuses, including active, expired, and exempt studies, while collaborating with HVTI principal investigators and research team members to ensure accurate records and compliance. Additionally, you will partner with Prospective Clinical Research and CORR team members to support IRB processes, address resource needs, and promote best practices.

While managing multiple priorities can be challenging, you will be supported by a collaborative team dedicated to advancing your research skills and contributing to discoveries that improve patient care. Join a culture committed to innovation, education, and making a meaningful impact on patients’ lives.

A caregiver in this role works days from 8:00 a.m. -- 5:00 p.m.

A caregiver who excels in this role will:

• Coordinate the compliant implementation and conduct of human subject research projects.

• Maintain regulatory documents and binders, conduct data management, complete IRB submissions and communicate with the research team.

• Report and complete serious adverse events and/or safety logs.

• Communicate with sponsors, monitors and research personnel to ensure all aspects of study compliance.

• Serve as a liaison between investigators, research personnel, outside study personnel and central research administration offices to assist in protocol interpretation, enrollment and safety questions.

• Schedule pre-site selection visits, site initiation visits, webinars, monitoring and close-out visits.

• Plan, conduct and evaluate project protocols and research subject recruitment.

• Monitor and report project status and research data.

• Complete regulatory documents, data capture, monitoring plans and protocol-related activities.

• Assist with preparing and responding to audits and maintaining research tools.

• Serve as a resource for IRB Webkit Training and Education of HVTI research personnel.

• Coordinate IRB submissions for new retrospective, (minimal risk) prospective, and registry studies.

• Prepare documents for new IRB studies, amendments, continuing renewals and closures.

• Review and maintenance of IRB status (active, expired, exempt) and study personnel within IRB Webkit in collaboration with HVTI principal investigators and study team members.

• Collaborate with Prospective Clinical Research and CORR team members to assist with IRB processes.

Minimum qualifications for the ideal future caregiver include:

• High School Diploma or GED and three years of experience as a Research Coordinator I or performing the role of a Research Coordinator I

• OR Associate's or Bachelor's degree in health care or science related and one year of experience as a Research Coordinator I or performing the role of a Research Coordinator I

• Proficient with computer-based skills such as word processing, spreadsheets, database and presentation software

• Understand basic concepts of study design

Preferred qualifications for the ideal future caregiver include:

• Associate or Bachelor's degree in health care or science related field

• Computer acumen (Outlook, Excel, research databases)

• IRB experience (submissions, renewals, amendments)

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

• In some locations, ability to move up to 25 pounds

Personal Protective Equipment:

• Follows standard precautions using personal protective equipment as required.

• May require working irregular hours.

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.