Research Coordinator III - Pediatrics

Cleveland Clinic

2d•Hybrid

About The Position

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. Cleveland Clinic Children’s is an inclusive, supportive team providing world-class care for our youngest patients. As a Research Coordinator III for Pediatrics, you play a crucial role in supporting clinical studies by following policies and protocols and conducting patient visits in clinic, including consenting patients, completing questionnaires, and assisting with sample collection. You will also perform data entry and maintain various systems to ensure the smooth operation of the studies. Research is a foundational tenet of the Cleveland Clinic, enabling the organization to prioritize patients by providing access to innovative, cutting-edge therapies. Cleveland Clinic Children’s embodies an inclusive and collaborative environment, delivering world-class care to our youngest patients. A caregiver in this position works days from 9:00 a.m. – 5:30 p.m. This role offers flexibility to work hybrid up to 3 days a week after completing the initial new hire period, depending on the needs of the department and studies. A caregiver who excels in this role will: Demonstrate exceptional coordination and compliance of 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
Clinical research experience in pediatric research that includes IRB submissions and maintenance, consenting, patient visits both onsite and remote and monitoring visits
Regulatory experience

Responsibilities

Demonstrate exceptional coordination and compliance of 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.