Clinical Research Coordinator I

Duties And Responsibilities

• Maintain all aspects of study protocol during recruitment, screening, enrollment, and follow-up visits
• Auxiliary the PI and team in the informed consent process with patients and their families
• Execute patient visits including patient demography, vitals, EKG, phlebotomy, photography, administration of investigational drugs, physical exams, and scheduling follow-up visits
• Communicate with contract research organizations, IRBs, sponsors, central lab facilities, and other vendors to manage trial needs
• Manage regulatory documents related to ISF
• Follow Standard Operating Procedures (SOPs), policies, and procedures as outlined by the company
• Enter source data into Electronic Data Capture (EDC) systems efficiently and accurately
• Monitor EDC for accuracy and completeness, and resolve queries as needed
• Support direct patient care procedures, such as biopsies, surgeries, cosmetic procedures, and related tasks
• Handle prescription processing and prior authorization requests, addressing patient/pharmacy inquiries about medications
• Enroll patients in patient education/assistance programs
• Scan correspondence into electronic medical records (EMR)
• Practice safety, environmental, and infection control methods
• Assist the clinical research manager with assigned tasks
• Perform miscellaneous job-related duties as directed
• Process blood and urine samples in compliance with International Air Transport Association (IATA) and Occupational Safety and Health Administration (OSHA) standards
• Prepare necessary documentation for site initiation visits (SIV), interim monitoring visits (IMV), and other sponsor-related meetings