Research Coordinator II - IRB Specialist

Cleveland Clinic; Cleveland (OH); On-site; USD 48,000 - 72,000; Full time

Job summary

Cleveland Clinic's Main Campus is seeking a Research Coordinator II to support HVTI IRB activities for retrospective and minimal risk studies. You will coordinate IRB submissions, maintain regulatory documents, and assist with data management.

You will collaborate with HVTI investigators and CORR teams to ensure compliance, monitor study status, and prepare documentation for amendments, renewals, and closures.

Qualifications

• High School Diploma or GED with 3 years of experience as a Research Coordinator I.
• Associate's or Bachelor's degree in health care or science plus 1 year of relevant experience.
• Proficient with word processing, spreadsheets, databases and presentation tools.
• Understand basic concepts of study design.

Responsibilities

• Coordinate IRB submissions for retrospective, minimal risk prospective and registry studies.
• Maintain regulatory documents and study binders; perform data management and communications with the research team.
• Report serious adverse events and safety logs; ensure study compliance with sponsors and staff.
• Serve as liaison between investigators, study personnel and central research offices.
• Schedule site visits, webinars and monitoring; assist with protocol interpretation and enrollment.
• Prepare and respond to audits; maintain IRB status in WebKit; collaborate with HVTI and CORR teams.

Skills

IRB submissions

Data management

Regulatory compliance

Research coordination

Sponsor communication

Education

High School diploma or GED

Associate's or Bachelor's degree in health care or science

Tools

Word processing

Spreadsheets

Database software

Presentation software

Outlook

Excel

Job description

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.

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 displayed does not include any applicable pay practices (e.g., shift differentials, overtime, etc.). The pay range does not include the value of Cleveland Clinic’s benefits package (e.g., healthcare, dental and vision benefits, retirement savings account contributions, etc.).