An advanced 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 studies including screening, recruitment, data collection, and data entry to ensure protocol compliance and human subjects’ protection.
Serve as the primary coordinator on more-than-minimal-risk, high acuity, and / or complex studies. Serves as the liaison between study team, research cores / units / departments, ancillary hospital departments / services, sponsor, and IRB to ensure cross-communication and protocol compliance
# Delegate tasks to the Clinical Research Coordinator I and Research Assistant in accordance with the delegation of authority log to ensure study is executed appropriately and efficiently
# 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
# 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
Bachelor’s degree in science or health related field
~3 years of prior clinical research coordination or nursing experience required
~ Certified as a Clinical Research Professional, or will obtain CCRP within 6 months of becoming eligible, but no later than 2 years after hire
Computer competency in using Microsoft Office including Word, Excel, and Outlook; prior experience with Electronic Data Capture (EDC) systems or databases is preferred
Proficient knowledge of medical terminology and human subject research
Ability to read, write, speak, and understand English
Ability to communicate effectively, both verbally and in writing
Ability to travel throughout the JHACH service areas in a timely manner.
Compensation will be commensurate with equity and experience for roles of similar scope and responsibility. We are committed to creating a welcoming and inclusive environment, where we embrace and celebrate our differences, where all employees feel valued, contribute to our mission of serving the community, and engage in equitable healthcare delivery and workforce practices.
Johns Hopkins Health System and its affiliates are drug-free workplace employers.
Clinical Research Coordinator • Saint Petersburg, FL, US