Clinical Research Coordinator II

Job Description

Job Description

POSITION SUMMARY :

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.

Shift : Full Time / Day Shift

Location : St Petersburg, FL

KEY ACCOUNTABILITIES :

• 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

QUALIFICATIONS :

Salary Range : Minimum / hour - Maximum / hour. Compensation will be commensurate with equity and experience for roles of similar scope and responsibility. In cases where the range is displayed as a $0 amount, salary discussions will occur during candidate screening calls, before any subsequent compensation discussion is held between the candidate and any hiring authority.

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