Clinical Research Coordinator I - Pulmonary Research Program / Lung Institute

Benefits

Qualifications

• •High School Diploma/GED, required
• •1 year of clinical research related experience, required

Responsibilities

• •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
• •This position is responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries
• •The incumbent will be responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information
• •The CRC I member will present 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)
• •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
• •Shift Duration : 8 hour
• •12 more items(s)