Research Coordinator II

at  Cleveland Clinic

Department - Division Institute: 1254
Join the Cleveland Clinic team, where you will work alongside passionate caregivers and provide patient-first healthcare. At Cleveland Clinic, you will work alongside passionate and dedicated caregivers, receive endless support and appreciation, and build a rewarding career with one of the most respected healthcare organizations in the world.
Our Pathology-Diagnostics department is looking to add a Research Coordinator to their multi-disciplinary, talented team. As a Research Coordinator, you will coordinate the compliant implementation and conduct of human subject research projects, typically of medium workload and medium complexity.

The ideal caregiver is someone who:

• Has research and clinical experience.
• Excels working independently and as part of a team.
• Is organized and detail oriented.
• Demonstrates a strong work ethic.

This opportunity allows you to be valued as a team member and supported as you achieve your goals. You will have opportunities for learning, career growth, and professional development.
At Cleveland Clinic, we know what matters most. That’s why we treat our caregivers as if they are our own family, and we are always creating ways to be there for you. Here, you’ll find that we offer: resources to learn and grow, a fulfilling career for everyone, and comprehensive benefits that invest in your health, your physical and mental well-being and your future. When you join Cleveland Clinic, you’ll be part of a supportive caregiver family that will be united in shared values and purpose to fulfill our promise of being the best place to receive care and the best place to work in healthcare.

EDUCATION:

• High School Diploma or GED required.
• Associate’s or Bachelor’s degree in health care or science related field preferred.
• Associate’s or Bachelor’s degree in health care or science related field may substitute for two years of experience requirement.

WORK EXPERIENCE:

• Minimum three years’ experience as a Research Coordinator I or performing the role of a Research Coordinator I. Associate’s or Bachelor’s degree in health care or science related field may offset two years of experience requirement.

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

• Coordinates the implementation and conduct of research projects ensuring adherence to research protocol requirements which may include: maintenance of regulatory documents and binders, data management, IRB submissions and communication of such to the research team.
• May be responsible for reporting/completion of Serious Adverse Events and/or safety log as defined per protocol as they occur and completion of Food and Drug Administration (FDA) and sponsor forms in accordance with GCP guidelines.
• Communicates with sponsors, monitors, research personnel to ensure all aspects of study compliance.
• May 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.
• Collaborates with study team to schedule pre-site selection visits, site initiation visits, webinars, monitoring and close-out visits.
• Collaborates with primary investigator, sponsor and research staff to plan, conduct and evaluate project protocols, including research subject recruitment.
• Monitors and reports project status.
• Completes regulatory documents, data capture and monitoring plans.
• Completes protocol related activities.
• As delegated, may be required to attain and maintain clinical competencies for unlicensed caregivers such as phlebotomy, vital signs, ECG, POC testing and other testing as required.
• Monitors research data to maintain quality.
• Understands basic concepts of study design.
• Demonstrates comprehension of assigned research protocols.
• Develops and maintains knowledge of research protocol to coordinate the comprehensive and compliant execution of assigned protocols.
• Assists with preparation for audits and response to audits.
• May assist in the development and maintenance of research tools, such as spreadsheets, questionnaires and/or brochures.
• Maintains study personnel certification records (License, CV, CITI).
• Maintains professional relationships, including frequent and open effective communication with internal and external customers.
• Documents the education and training of research personnel as needed.
• May participate in the conduct and documentation of the informed consent process.
• May assist PI with research study design and development of the research protocol.
• May contribute to research project budget development.
• Performs other duties as assigned.