Clinical Research Coordinator I

Duties And Responsibilities

• Maintain all aspects of study protocol during recruitment, screening, enrollment, and follow-up visits
• Aid the PI and team in the informed consent process with patients and their families
• Conduct and coordinate patient visits including patient demography, vitals, EKG, phlebotomy, photography, administering investigational drug, assisting PI and sub-investigators with physical exam, and scheduling appropriate follow-up visits
• Communicate frequently with contract research organizations, IRB, Sponsors, Central Lab Facilities, and other outside vendors to manage the day-to-day needs for current and prospective trials
• Maintain all source documents and investigational drug accountability records
• Enter source data into EDC efficiently and accurately
• Maintain regulatory documents related to ISF
• Follow SOPs, policies, and procedures as set forth by the company
• Review EDC for accuracy and completion, and resolve queries as they arise
• Aids with direct patient care procedures, as required by the study, including biopsies, surgeries, cosmetic procedures and related tasks
• Processes prescriptions and prior authorizations as directed by physician. Addresses patient and/or pharmacy questions concerning medication. Enrolls patients in patient education/assistance programs
• Ensures necessary study related documentation and correspondence between study subjects, study teams, vendors, and sponsors
• Scans correspondence into EMR
• P Practices safety, environmental, and/or infection control methods
• Aids in delegated tasks for the clinical research manager
• Performs miscellaneous job-related duties as assigned
• Processes blood and urine samples in accordance with IATA and OSHA standards
• Prepares necessary documentation for SIV, IMV, COVs and other sponsor related meetings