Hand Study Coordinator

Job Summary

Hand Study Coordinator
Helps with the logistical and administrative aspect of clinical trials and studies, ensuring adherence to protocols and regulatory requirements. Help facilitate participant recruitment, consent processes, and documentation management. Coordinate study visits, monitor adverse events, and maintain accurate records for successful study outcomes.

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Responsibilities

• Assesses protocol for clarity and subject safety, reviews inclusion/exclusion criteria; clarifies concerns and questions with Principal Investigator and sponsor.
• Attends and participates in Investigator and staff meetings.
• Advises team regarding specific study assignments and timelines.
• Explains and obtains informed consent, medical history and demographics; documents in source file and maintains with historical data, status reports, progress notes, and subject log to help ensure subject safety.
• Determines length of visits and coordinates related facility and equipment availability.
• Reports and tracks adverse events (AE). Reports serious AEs to IRB and sponsor.
• Documents all protocol deviations, reconciles test article accountability at study close out and prepares summary report for sponsor.
• Completes, audits, corrects CRFs, relays CRFs to sponsor.
• Assists with negotiating contract budget and payment terms.
• Maintains documents as required by FDA guidelines.
• Incumbents are responsible for coordinating the daily operations of their assigned research team, coordinating the orderly and safe flow of the research project and maintaining adequate resources for the PI to accomplish their research objectives.

May maintain contact with IRB and prepare and submit IRB documents. May ensure proper collection, processing and shipment of specimens. May perform functions required of the Clinical Research Assistant as necessary.