Clinical Research Coordinator 臨床研究協調員 (1-year contractor)

The Clinical Research Coordinator manages the day-to-day operations of clinical trials at the investigational site under the direction of the Principal Investigator (PI). The SC ensures strict adherence to the protocol, ICH GCP guidelines, and local regulatory requirements, safeguarding subject safety and data integrity.

• Subject Management & Recruitment

o Assist the PI in identifying, screening, and recruiting eligible trial participants.
o Guide subjects through the Informed Consent Form (ICF) process legally and ethically.
o Schedule patient visits and follow-ups to maintain high subject retention.

• Trial Execution & Administration

o Handle Institutional Review Board (IRB) submissions, amendments, and notifications.
o Maintain and update the Investigator Site File (ISF) to ensure audit readiness.
o Manage trial logistics, including investigational product (IP) accountability and lab speci-men handling.

• Data Management & Compliance

o Abstract data from medical records and perform timely entry into Electronic Data Capture (EDC) systems.
o Apply ALCOA+ principles to guarantee high-quality, verified source documentation.
o Resolve data queries initiated by Clinical Research Associates (CRAs) promptly.
o Assist in processing and reporting Serious Adverse Events (SAEs) within required timelines.

• Stakeholder Coordination

o Act as the primary site contact for sponsors, CROs, and monitoring CRAs.
o Facilitate site monitoring visits, audits, and inspections.
o Coordinate trial logistics across hospital departments (e.g., pharmacy, radiology, central labs).