About this role

Scheduling of research participants for research visits and procedures.
In collaboration with the physician and other medical personnel, documents on Case Report Forms (CRFs) information about changes in research participant condition, adverse events, concomitant medication use, protocol compliance, and response to study drug.
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 following 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.
Participates in required training and education programs.
Coordinates training and education of other personnel.

Clinical Research Coordinator I – Biobank Research Program

Key skills