Clinical Research Coordinator

PRINCIPAL DUTIES AND RESPONSIBILITIES: 

• Recruit and enroll eligible study participants from clinics throughout the hospital and other sites
• Arrange and conduct initial interviews of study subjects and evaluate criteria for inclusion/exclusion
• Perform Institutional Review Board (IRB) submission process by preparing protocol applications, amendments, safety reports, adverse event reports and other documents
• Capture clinical information from record review and patient interview into study database
• Manage and maintain regulatory documents for audit by FDA, as needed
• Prepare and manage regulatory documents for audit by FDA, as needed
• Evaluate and update medical records and maintain study database
• Coordinate subject care by scheduling and arranging follow-up visits, conducting follow-up telephone calls, and communicating concerns with the study investigator
• Conduct regular review of study progress and follow-up

 

EXPERIENCE: 

• Background in biology, immunology, biochemistry, biostatistics, epidemiology or related pre-medicine discipline preferred, but not required
• Experience in a clinical research environment or with specimen biobanking preferred
• A 2-year commitment is preferred, but not required