Senior Clinical Research Coordinator - Cardiovascular Lab

Cleveland Clinic; Cleveland (OH); In loco; USD 70.000 - 100.000; Tempo pieno

Descrizione del lavoro

Cleveland Clinic Main Campus in Cleveland hosts the Nguyen Lab within the Cardiovascular Innovation Research Center. The Research Coordinator III role supports complex trials at the intersection of cardiology and bioengineering, translating innovations into clinical context.

You will coordinate multi-center studies, manage regulatory tasks, ensure GCP compliance, and collaborate with investigators, sponsors and care teams to drive study success and patient outcomes.

Competenze

• High School Diploma or GED and five years of experience as a Research Coordinator II or equivalent
• 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 and presentation software)
• Understanding of the basic concepts of study design

Mansioni

• 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 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.

Formazione

High School Diploma or GED

Bachelor’s Degree in healthcare or science-related field

Proficient with Word processing, Outlook, Excel, databases and presentation software

Understanding of basic study design

Strumenti

Excel

Outlook

Word processing

Databases

PowerPoint

Descrizione del lavoro

Cleveland Clinic Main Campus in Cleveland hosts the Nguyen Lab within the Cardiovascular Innovation Research Center. The Research Coordinator III role supports complex trials at the intersection of cardiology and bioengineering, translating innovations into clinical context.

You will coordinate multi-center studies, manage regulatory tasks, ensure GCP compliance, and collaborate with investigators, sponsors and care teams to drive study success and patient outcomes.