Research Coordinator III - Quantitative Health Sciences

About the position At Cleveland Clinic Health System, we believe in a better future for healthcare. And each of us is responsible for honoring our commitment to excellence, pushing the boundaries and transforming the patient experience, every day. We all have the power to help, heal and change lives — beginning with our own. That’s the power of the Cleveland Clinic Health System team, and The Power of Every One. 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. Groundbreaking discoveries happen every day at Cleveland Clinic. Each member of our team contributes to our mission of caring for life, researching health, and educating those who serve the community. As a Research Coordinator III supporting studies related to diffuse parenchymal lung disease, you will manage complex clinical trials and advanced regulatory responsibilities, including IRB oversight, submissions, and adherence to regulatory requirements for drug trials. Because of these responsibilities, self-drive, strong organization, effective time management, and a desire to continually learn are essential. In this role, your team will encourage and support your growth as you strengthen your skills in both research and study management. A caregiver in this position works days from 9:00 a.m. – 5:00 p.m. After successfully completing the 90-day orientation, caregivers will have the opportunity to work one day remotely each week.

Responsibilities

• Demonstrate exceptional coordination and compliance with the implementation and conduct of human subject research projects.
• Assist with research study design and protocol development as applicable.
• Independently direct large, complex, multi-center clinical research protocols/programs and coordinate the implementation and conduct of research projects, ensuring adherence to research protocol.
• Report Serious Adverse Events and/or safety as they occur and complete Food and Drug Administration (FDA) and sponsor forms in accordance with GCP guidelines.
• 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.
• Collaborate with primary investigators, sponsors and research caregivers to plan, conduct and evaluate project protocols, including research subject recruitment.
• Monitor and report project status.
• Complete regulatory documents, data capture and monitoring plans.
• Complete and oversee protocol related activities.
• As delegated, attain and maintain clinical competencies for unlicensed caregivers, such as phlebotomy, vital signs, ECG, POC testing and other testing as required.
• Oversee and monitor research data to maintain quality.
• Develop and maintain knowledge of research protocols to coordinate the comprehensive and compliant execution of assigned protocols.
• Assist with the preparation for audits and response to audits.
• Develop or assist in the development and maintenance of research tools, such as spreadsheets, questionnaires and/or brochures.
• Maintain study personnel certification records (License, CV, CITI).
• Conduct and document the informed consent process.
• Assist the PI with research study design and development of research protocol.
• Submit the study to appropriate agencies in support of the research programs and assist with annual and other reporting requirements.
• Contribute to or assist with research project budget development.

Requirements

• High School Diploma or GED and five years of experience as a Research Coordinator II or performing the role of a Research Coordinator II OR Bachelor’s Degree in a healthcare or science-related field and three years of experience
• Proficient with a variety of computer-based skills (word processing, Outlook, Excel, spreadsheets, databases and presentation software)
• Understanding of the basic concepts of study design

Nice-to-haves

• Associate’s or Bachelor’s Degree in a healthcare or science-related field
• Experience with managing multiple trials
• Thirst for knowledge to learn research and different disease groups

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