Clinical Research Coordinator
Austin, TXJobSeen 5 days agoSeen in employer's feed 5 days ago
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Job overview
The Clinical Research Coordinator manages day-to-day clinical trial activities, including participant recruitment, screening, enrollment, and study visits. The role collects and verifies trial data, maintains regulatory documentation, and supports compliance with protocols, regulatory requirements, and Good Clinical Practice guidelines. It also involves informing and consenting participants, monitoring their well-being, and communicating study progress with investigators, research teams, sponsors, and other stakeholders.
Skills & qualifications
Skills
Full job description
Study Coordination Manages the day-to-day activities of clinical trials. Ensures compliance with study protocols and regulatory requirements. Coordinates participant recruitment, screening, and enrollment. Maintains accurate and timely documentation of study activities.Data Management Collects, enters, and verifies clinical trial data. Ensures data integrity and accuracy. Prepares data reports for review by the PI and sponsors. Manages electronic data capture systems.Regulatory Compliance Prepares and submits regulatory documents to IRBs and other regulatory bodies. Ensure ethical approval for studies is maintained, from initial approval through amendments, annual renewals, and terminations. Ensures adherence to Good Clinical Practice (GCP) guidelines. Maintains regulatory binders and essential documents. Coordinates audits and inspections.Participant Interaction Informs and consents study participants. Schedules and conduct study visits. Monitors participant safety and well-being. Provides education and support to participants.Collaboration and Communication Communicates study progress and issues to the PI and research team. Liaises with sponsors, monitors, and other external stakeholders. Participates in team meetings and training sessions. Facilitates effective teamwork and collaboration.
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