Clinical Research Coordinator I

Johns Hopkins Medicine • Saint Petersburg, FL

50d

About The Position

The Clinical Research Coordinator I (CRC I) is a member of the study team who under the direction of the Principal Investigator and Director of Research Operations is responsible for the overall coordination of assigned minimal-risk studies including regulatory submissions, screening, recruitment, data collection, and data entry to ensure protocol compliance and human subjects protection.

Requirements

• Bachelor's degree in science or health related field
• 2 years of prior clinical research assistant, direct patient care services, or nursing or other healthcare related certification experience
• Computer competency in using Microsoft Office including Word, Excel, and Outlook
• Ability to follow protocols and directions very closely
• Ability to read, write, and speak, English, and be comfortable communicating with patient populations
• Prior experience utilizing Electronic Medical Records (EMR)
• Ability to travel throughout the JHACH service areas in a timely manner.

Responsibilities

• Serve as the primary coordinator on minimal-risk studies. Serve as liaison between study team, research cores/units/departments, ancillary hospital departments/services, sponsor, and IRB to ensure cross-communication and protocol compliance
• Coordinate the preparation and submission of regulatory documentation to the sponsor and Institutional Review Board (IRB) during all phases of study conduct including start-up, continuing reviews, changes in research, problem events, and closure to ensure human subjects protections and regulatory compliance
• Operationalize the recruitment plan and obtain or coordinate the informed consent process to ensure the participant understands the information and volunteers to participate free of coercion
• Coordinate and/or perform study visits/interventions/observations to ensure they are conducted according to protocol
• Monitor participants for adverse events and study conduct for protocol deviations and events and report accordingly to Principal Investigator, sponsor, and IRB to ensure participant safety and protocol compliance, and participate in the Corrective and Preventative Action planning where applicable
• Coordinate and perform data collection from various sources including medical records and enter data into research database to ensure accurate and timely data entry
• Maintain organized and up-to-date research records including regulatory binders and participant records to ensure study documentation is audit-ready

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Hospitals
• Number of Employees: 5,001-10,000 employees