Research Coordinator III

Cleveland Clinic • Cleveland, OH

343d • $27 - $42

About The Position

The position involves exceptional coordination and compliance in the implementation and conduct of human subject research projects, typically characterized by a high workload and complexity. The role includes assisting with research study design and protocol development as applicable.

Requirements

• High School Diploma or GED required.
• Associate's or Bachelor's degree in health care or science related field strongly preferred.
• Five years experience as a Research Coordinator II or performing the role of a Research Coordinator II.

Nice To Haves

• Bachelor's degree in health care or science related field may substitute for two years of experience requirement.

Responsibilities

• Independently directs large, complex, multi-center clinical research protocols/programs and coordinates the implementation and conduct of research projects ensuring adherence to research protocol requirements.
• Maintains regulatory documents and binders, data management, IRB submissions, and communication of such to the research team.
• Develops data capture and monitoring plans.
• Reports Serious Adverse Events and/or safety logs as defined per protocol and completes FDA and sponsor forms in accordance with GCP guidelines.
• Communicates with sponsors, monitors, and research personnel to ensure all aspects of study compliance.
• Serves as a liaison between investigators, research personnel, outside study personnel, and central research administration offices.
• 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 and may oversee protocol-related activities.
• Attains and maintains clinical competencies for unlicensed caregivers as required.
• Oversees and monitors research data to maintain quality.
• Develops and maintains knowledge of research protocol to coordinate the execution of assigned protocols.
• Assists with preparation for audits and response to audits.
• Develops or assists in the development and maintenance of research tools, such as spreadsheets, questionnaires, and brochures.
• Maintains study personnel certification records (License, CV, CITI).
• Maintains professional relationships with effective communication with internal and external customers.
• Assists with the development of training and educational material for assigned research protocols.
• Conducts and documents the informed consent process.
• Assists PI with research study design and development of research protocol.
• Submits the study to appropriate agencies in support of the research programs and assists with reporting requirements.
• Contributes to or assists with research project budget development.
• Performs other duties as assigned.

Benefits

• Healthcare, dental, and vision insurance
• Retirement benefits
• Professional development opportunities
• Paid time off

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Ambulatory Health Care Services
• Education Level: Associate degree