Clinical Research Coordinator

Job Summary: The Clinical Research Coordinator is responsible for the independent coordination and management of complex clinical trials across multiple therapeutic areas. This role provides advanced clinical and operational support to Principal Investigators and serves as a key liaison between sponsors, regulatory bodies, and institutional departments to ensure the successful execution of clinical research studies. This position supports interventional trials sponsored by pharmaceutical, biotechnology, and medical device industries, and requires a high level of clinical judgement, regulatory knowledge, and organizational expertise.

Essential Job Functions & Accountabilities:

• Independently manages all phases of clinical trials, including start-up, activation, enrollment, maintenance, and close-out.
• Performs and oversees patient screening, recruitment, informed consent, and enrollment processes.
• Coordinates and conducts study visits in accordance with protocol requirements, including clinical assessments and specimen collection.
• Ensures compliance Good Clinical Practice (GCP), institutional policies, and applicable regulatory requirements (e.g. FDA).
• Serves as the primary point of contact for sponsors, monitors, and auditors, lead and support monitoring visits, audits and inspections.
• Maintains accurate and timely documentation, including source documents, case report forms, and regulatory documents, performing quality checks to maintain compliance.
• Identifies and proactively resolves protocol or operational issues, including recruitment barriers and protocol deviations.
• Monitors and documents adverse events and protocol deviations, reporting them to the Principal Investigator in a timely manner.
• Coordinates the scheduling of participant visits in accordance with the research protocol.
• Assists in the development of study-specific source documents and other materials required for proper implementation of the clinical trial.
• Provides mentorship and guidance to Research Associates.
• Collaborates with investigates and leadership to assess study feasibility and support study selection.
• Assists in budget development, and contract review, and resource planning as needed.
• Rotates on an on-call schedule to meet study needs.
• Attends investigator meetings that may require out-of-state weekday and/or weekend travel, as needed.
• Job description is not an all-inclusive list of duties and may be subject to change with or without notice. Staff are expected to perform other duties as assigned.