Research Coordinator II - IRB Specialist

About the Role

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. You will serve as a resource for IRB WebKit training and education for HVTI research personnel, coordinate IRB submissions, and prepare documentation for new studies, amendments, continuing renewals, and closures.

Responsibilities

• 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 maintain 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.

Requirements

• 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 healthcare or science-related field 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

• Associate or Bachelor's degree in healthcare 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
• Follows standard precautions using personal protective equipment as required
• May require working irregular hours

Pay

Pay Range Minimum Annual Salary: $47,530.00

Maximum Annual Salary: $72,475.00

The pay range displayed on this job posting reflects the anticipated range for new hires. A successful candidate’s actual compensation will be determined after taking factors into consideration such as the candidate’s work history, experience, skill set, and education. The pay range does not include any applicable pay practices (e.g., shift differentials, overtime, etc.) or the value of Cleveland Clinic’s benefits package (e.g., healthcare, dental and vision benefits, retirement savings account contributions, etc.).

Schedule

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