Research - Laboratory/Non-Laboratory, Staff/Administrative
Position Type : Full Time
The clinical research coordinator will assist in the coordination of clinical trials, Phase I-IV, for the Pulmonary Vascular Disease Program. Screen, recruit, consent and enroll eligible subjects using GCP guidelines. Implement various research protocols and guidelines. Provide education to the patient and/or families. Responsible for management and oversight of research medication administration, monitoring of patient care, monitoring of side effects/adverse events, and maintaining general oversight of patient status throughout study period. Will record and report adverse events and serious adverse events per protocols. Manage patient treatment per protocol, schedule clinical and research office visits, interact with cardiology and pulmonary staff to schedule and oversee research testing. Responsible for drawing labs (phlebotomy training preferred), sample processing and shipping. Responsible for performing vital signs and EKGs for study visits. Responsible for the preparation and processing of all Institutional Review Board (IRB) documentation through the IRB and defined regulatory authorities, including submissions, continuing reviews, amendments and adverse event reporting. Responsible for accurate data collection and data entry. Work closely with study sponsors and physicians. Communicate any research issues to PI and primary MD, communication with research team, including Investigators, project managers, CRC and regulatory team, to ensure patient safety and proper study conduct. Demonstrate vigilance in patient safety, protocol compliance, and data quality. Other duties as assigned. Perform these tasks with minimal supervision after initial training.
Internal Number: 40662
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