Clinical Research Coordinator I - Kidney Transplant

About the role

The Clinical Research Coordinator I works independently providing study coordination, including screening potential patients for protocol eligibility, presenting non-medical trial concepts and details, 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 to 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) changes in patient condition, adverse events, concomitant medication use, protocol compliance, and response to study drug.
• Maintains accurate source documents related to all research procedures.
• Accurate and timely data collection, documentation, entry, and reporting, including timely response to sponsor queries.
• Schedules and participates in monitoring visits, site initiation visits (SIVs), close-out visits (COVs), and auditing activities.
• Communicates with sponsors regarding exceptions and protocol clarifications.
• Compiles and reports on each study, including information related to 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).
• 1 year of clinical research-related experience (required).
• Certification in Clinical Research (SOCRA or ACRP) upon hire (preferred).