Clinical Research Coordinator I -Surgery Chair

About the role

The Clinical Research Coordinator I works independently providing study coordination within the Surgery Chair Department. Responsibilities include screening potential patients for protocol eligibility, presenting non-medical trial concepts, and participating in the informed consent process.

Responsibilities

• Independent study coordination, including screening potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process.
• Schedules patients for research visits and procedures.
• In collaboration with physicians and other medical personnel, documents changes in patient condition, adverse events, concomitant medication use, protocol compliance, and response to study drug on Case Report Forms (CRFs).
• Maintains accurate source documents related to all research procedures.
• Ensures accurate and timely data collection, documentation, entry, and reporting, including responding to sponsor queries.
• Schedules and participates in monitoring and auditing activities.
• Compiles and reports on each study, including protocol activity, accrual data, workload, and other research information; presents this information at regular research staff meetings.
• 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/IRB duties, budgeting duties, and assist with patient research billing and reconciliation.
• Ensures compliance with all federal and local agencies, including the Food and Drug Administration (FDA) and local IRB.
• 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.

Requirements

• High School Diploma/GED required.
• Bachelor's Degree in Science, Sociology, or related field preferred.
• One (1) year of clinical research-related experience required.
• SOCRA or ACRP certification preferred upon hire.
• Prior experience in FDA-regulated interventional clinical trials and/or drug or cell therapy strongly desired.
• Experience with OnCore, Florence eBinders, Redcap, or EDC systems is a bonus.