Clinical Research Coordinator I, Hybrid

About the role

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. They are responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. They compile and report on each study including information related to protocol activity, accrual data, workload, and other research information. They present this information at regular research staff meetings. They ensure compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

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.
• 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.
• Accurately and timely collects, documents, enters, and reports data including timely responses to sponsor queries.
• Schedules and participates in monitoring and auditing activities.
• Compiles and reports on each study including information related to protocol activity, accrual data, workload, and other research information; present 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 / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
• Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
• 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 - minimum
• Bachelor's Degree Science, Sociology or related degree - preferred
• 1 year Clinical research related experience - minimum
• No license or certification required - minimum
• Certification In Clinical Research - Upon Hire preferred SOCRA or ACRP certification