Clinical Research Coordinator II - Pulmonary Research Program / Lung Institute

Benefits

Qualifications

• •High School Diploma/GED, required
• •2 years of clinical research related experience, required

Responsibilities

• •As a Clinical Research Coordinator II, you will work independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process
• •The incumbent will be responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries
• •The CRC II member will be responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information
• •The incumbent will present information at research staff meetings, may plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities
• •This position 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
• •May coordinate training and education of other personnel
• •May participate in centralized activities such as auditing, Standard Operating Procedure development, etc
• •May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality
• •May identify new research opportunities and present to investigators
• •Participates in required training and education programs
• •16 more items(s)