Clinical Research Coordinator I - Pulmonary Research Program/Lung Institute

About the role

Work alongside physician-scientists and researchers who are making life-saving medical and scientific breakthroughs. Our team of scientists develop some of the most advanced clinical trials in the world. The Clinical Research Coordinator I will work independently providing study coordination, screening of patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process.

Responsibilities

• Schedules patients for research visits and procedures
• In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following: changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug
• Maintains accurate source documents related to all research procedures
• Schedules and participates in monitoring and auditing activities
• Notifies direct supervisor about concerns regarding data quality and study conduct
• Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines
• May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation
• Maintains research practices using Good Clinical Practice (GCP) guidelines
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law
• Participates in required training and education programs
• Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries
• Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information
• Presents study information at research staff meetings and ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB)

Qualifications

• High School Diploma/GED, required
• Bachelor's degree, preferred
• ACRP/SOCRA (or equivalent) certification, preferred
• 1 year of clinical research related experience, required