CLINICAL RESEARCH COORD A
Duties: Clinical Research Coordinator A will assist in the coordination of registry, observational, and occasionally clinical trials Phase I-IV for the Pulmonary Advanced Lung Disease Program.
Prescreen, recruit, consent and enroll eligible subjects. Implement various research protocols and guidelines. Responsible for management and oversight of research regulatory administration, monitoring of patient care, and maintaining general oversight of patient status throughout study period. Will record and report adverse events and serious adverse events per protocols (if applicable to studies). Under the supervision of the project manager, manage patient visit schedule (and, if applicable, study treatment) per protocol, including scheduling all clinical and research office visits in PennChart. Responsible for drawing labs (phlebotomy training preferred but can be taught), sample processing (including blood, urine, and sputum), and shipping samples on dry ice. Responsible for performing vital signs for study visits. Responsible for the preparation and processing of 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 monitors. Communicate any research issues to PI, communication with research team, including Investigators, project manager, other team members to ensure patient safety and proper study conduct. Demonstrate vigilance in patient safety, protocol compliance, and data quality. Other duties as assigned.
Qualifications: BA/BS with a minimum of 1-3 years clinical research experience, or an equivalent combination of education and experience, required. Pulmonary experience preferred. Phlebotomy expertise preferred. Effective communication and writing skills; ability to multi-task and problem solve. Energetic, interactive, and demonstrated ability to work as part of a team as well as independently. Knowledge of IRB and human research protection regulations. Must possess strong computer skills and be able to independently and proficiently work in MS office suite. Position contingent upon funding.
Reference Number: 40-27842
Salary Grade: 025
Employment Type: Exempt
Org: DM-Pulmonary, Allergy and Critical Care
Job Family: I-Technical/Professional Research