CLINICAL RESEARCH COORD B
Duties: With minimal supervision the clinical research coordinator will coordinate Phase I-IV clinical trials and registries for the Pulmonary Vascular Disease Program. Screen, recruit, consent and enroll eligible subjects per protocol 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. Organize and maintain all documentation required by the sponsor or CRO- includes source documentation, case report forms, and research charts. Responsible for accurate data collection and data entry. 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. 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. Participate in initiation, monitoring, audit and close-out visits. Participate in study team meetings and ongoing protocol training/compliance meetings. Demonstrate vigilance in patient safety, protocol compliance, and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines.
Qualifications: A Bachelor's degree and 2 years to 4 years of experience or equivalent combination of education and experience required. Phlebotomy expertise preferred. Effective problem solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations. Position contingent upon funding.
Reference Number: 40-27928
Salary Grade: 026
Employment Type: Exempt
Org: DM-Pulmonary, Allergy and Critical Care
Job Family: I-Technical/Professional Research