Clinical Research Coordinator II

Johns Hopkins Medicine•Saint Petersburg, FL

37d•$27 - $44

About The Position

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.

Requirements

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
Demonstrates knowledge and skills in accordance with Good Clinical Practice (GCP) guidelines, HIPAA, FDA regulations and other federally mandated guidelines
Must be comfortable working with patient populations
Computer competency in using Microsoft Office including Word, Excel, and Outlook; prior experience with Electronic Data Capture (EDC) systems or databases is preferred

Responsibilities

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
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