Clinical Research Coordinator I – Pulmonary Research

Are you looking to contribute to pioneering research? We look forward to having you join our team to collaborate on groundbreaking research!

The Clinical Research Coordinator I works independently providing study coordination, 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. This role is also 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 presents study information at regular 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).

Primary Duties and Responsibilities:

• Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.

• 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.

• Responsible for data collection, documentation, entry, and reporting including timely response to sponsor queries.

• 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 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.

High School Diploma/GED is required