Clinical Research Coordinator - PRN

Cleveland Clinic is a healthcare system committed to excellence and transforming the patient experience. The Clinical Research Coordinator coordinates the compliant implementation and conduct of low-workload, low-complexity human subject research projects, including regulatory documentation, data management, study coordination, monitoring, and recruitment activities.

What you'll do:

• Assists with the coordination, 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 as applicable
• Communicates with sponsors, monitors, research personnel to ensure all aspects of study compliance
• Collaborates with study team to schedule pre-site selection visits, site initiation visits, webinars, monitoring and close-out visits
• May collaborate 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
• Assists with completion of 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

What they're looking for:

• High School Diploma or GED
• Language required
• Requires excellent organizational, written, and verbal communication skills
• Must be able to take direction and appropriate action in a stressful environment
• Demonstrated proficiency with a variety of computer-based skills, especially in the use of word processing spreadsheets, database and presentation software, and the ability to undertake internet searches
• Solid written and verbal communication skills
• Must be self-directed with demonstrated ability to work in collaboration and cooperation with members of a multidisciplinary team
• Within 90 days of hire, must successfully complete certification in Human Subjects Research as required by the Responsible Conduct of Research guidelines adopted by Cleveland Clinic
• Minimum two years clinical research or healthcare experience required
• Associate or bachelor's degree in healthcare or science field may offset experience requirement
• Demonstrated proficiency with a variety of computer-based skills, especially in the use of word processing, spreadsheets, database and presentation software, and the ability to undertake internet searches
• Solid written and verbal communication skills

Benefits:

• Remote work option in the United States